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Police arrest landlord accused of running over tenant, killing him
PAHRUMP, Nev. (Gray News/KVVU) - A man is charged with open murder after police said he allegedly ran over his tenant with his vehicle and dragged his body down the road.
The Nye County Sheriff’s Office reported that 70-year-old William Stanley was arrested in the death of 66-year-old Frank Brink after Brink’s body was found on the side of the road on Sept. 6.
Deputies who responded to the report of a body found said there was evidence the body had been dragged to the location where it was discovered, according to Captain Davide Boruchowitz with the Nye County Sheriff’s Office.
Boruchowitz said deputies then followed a trail of blood and clothing to an address nearby where it appeared the dragging had begun.
The sheriff’s office identified the owner of the property as Stanley and said he was Brink’s landlord.
Upon further investigation, Boruchowitz reported deputies discovered the incident began with an argument between Stanley and Brink. A declaration of probable cause and detention obtained by KVVU reported Stanley admitted to running Brink over with his vehicle, killing him.
Stanley then reportedly used a rope to tie Brink’s leg to the back of the vehicle before dragging his body to the spot where it was later found, according to the declaration.
Boruchowitz said deputies found sufficient evidence during an executed search warrant to arrest Stanley.
Stanley was charged with open murder and was booked into the Nye County Detention Center without bail.
Copyright 2022 Gray Media Group, Inc. All rights reserved. KVVU contributed to this report. | https://www.ktre.com/2022/09/10/police-arrest-landlord-accused-running-over-tenant-killing-him/ | 2022-09-10T18:58:03 | en | 0.980093 |
Police: Man offers mother cash for daughter in attempted kidnapping
Published: Sep. 10, 2022 at 1:33 PM CDT|Updated: 23 minutes ago
CHICAGO (CNN) - Chicago police say they are searching for a suspect in an attempted kidnapping.
Authorities say a man tried to kidnap a 5-year-old girl Friday morning.
The girl and her mother were walking on a sidewalk when they said the man had approached them.
The man allegedly offered the mother cash for her daughter. Police said he tried to pull the girl toward him when she refused.
The mother and daughter were able to escape, but police are now looking for the man.
Police said the suspect is believed to be a white man, between the ages of 20 and 25, with bright red hair and a thin beard. He was last seen wearing a black T-shirt, red shorts and a black hat.
Copyright 2022 CNN Newsource. All rights reserved. | https://www.ktre.com/2022/09/10/police-man-offers-mother-cash-daughter-attempted-kidnapping/ | 2022-09-10T18:58:10 | en | 0.981221 |
Puerto Rico star Ricky Martin faces sexual assault complaint
SAN JUAN, Puerto Rico (AP) — A sexual assault complaint has been filed against Puerto Rico pop star Ricky Martin, who recently sued his nephew over what he said were false allegations of sexual abuse.
The complaint was filed Friday at a police precinct in the capital of San Juan, police spokesman Edward Ramírez told The Associated Press on Saturday. Information including who filed the complaint and details of the allegations are not public, given the nature of the complaint.
A person who was not authorized to speak about the case confirmed that Martin’s nephew, Dennis Yadiel Sánchez Martin, filed the complaint. The person said the complaint does not automatically trigger an arrest because the alleged incident is not recent, adding that police will investigate and determine whether charges are warranted.
Sánchez previously requested a restraining order against Martin in July, but a judge later archived the case after Sánchez admitted under oath that he had never been sexually assaulted by the singer.
Flavia Fernández, a spokeswoman for Martin, told the AP that his legal team is evaluating the situation and not issuing public comment for now.
On Thursday, the artist’s attorneys filed a lawsuit against his nephew, whom they described as “troubled.” They accused him of extortion, malicious persecution, abuse of law and damages.
They said Sánchez’s allegations cost Martin at least $10 million worth of canceled contracts and projects, plus another $20 million in damages to his reputation.
The lawsuit states that Sánchez would send up to 10 messages a day to Martin, the majority “meaningless diatribes without any particular purpose.” It also accuses him of publishing Martin’s private number, forcing him to change it.
In addition, the lawsuit said Sánchez falsely claimed he had a romantic relationship with Martin for seven months and that the singer didn’t want it to end and would call Sánchez with frequency.
“Nothing further from the truth,” the lawsuit stated.
Attorneys also noted that a judge previously issued Sánchez two restraining orders in an unrelated stalking case.
Copyright 2022 The Associated Press. All rights reserved. | https://www.ktre.com/2022/09/10/puerto-rico-star-ricky-martin-faces-sexual-assault-complaint/ | 2022-09-10T18:58:16 | en | 0.974907 |
Advertising Sponsors Include:
Procter & Gamble, Honda, AT&T, Stellantis, Walmart, Toyota, Bank of America, Verizon, Lexus, Meta, Allstate, Boost Mobile, Lowes, Kia, SC Johnson, UnitedHealthcare, Safelite, Macy's, Taco Bell, T.J. Maxx, Dairy Queen, Capital One, Geico, Pizza Hut, Mastercard, Target and Many More
LOS ANGELES, Sept. 9, 2022 /PRNewswire/ -- Byron Allen's Allen Media Group (AMG) is proud to announce it has secured numerous major Madison Avenue advertising sponsors for the launch of Historically Black Colleges and Universities (HBCU) sports for HBCU GO and theGrio Television Network's 2022-23 sports programming season. Brand sponsors include: Procter & Gamble, Honda, AT&T, Stellantis, Walmart, Toyota, Bank of America, Verizon, Lexus, Meta, Allstate, Boost Mobile, Lowes, Kia, SC Johnson, UnitedHealthcare, Safelite, Macy's, Taco Bell, T.J. Maxx, Dairy Queen, Capital One, Geico, Pizza Hut, Mastercard, Target and many more.
HBCU GO is the leading media provider for the nation's 107 HBCUs, and recently announced nationwide clearance for their 2022-23 sports season as part of a new carriage deal with CBS owned-and-operated broadcast television stations in key broadcast television markets including New York, Los Angeles, Philadelphia, Dallas, Atlanta, San Francisco, Boston, Seattle, Tampa, Detroit, Miami, and Pittsburgh. AMG's FREE-streaming digital platform HBCU GO brings together major HBCU NCAA conferences, with major market carriage across broadcast television, cable, satellite, and digital platforms. HBCU GO's 2022-23 season began this past Saturday, September 3 with "The HBCU GO Sports Kickoff Show." The three-hour pre-season special aired LIVE on the AMG platforms HBCU GO, theGrio Television Network, theGrio Streaming App, Sports.TV, Local Now, and on broadcast television stations throughout the U.S.
HBCUs are widely known for graduating exceptional athletes, celebrities, politicians, and historical figures including Dr. Martin Luther King, Jr., Wilma Rudolph, Althea Gibson, Walter Payton, Michael Strahan, Jerry Rice, Spike Lee, Alice Walker, Samuel L. Jackson, astronaut Ronald McNair, Alex Haley, Earl Graves, Oprah Winfrey, Chadwick Boseman, Justice Thurgood Marshall, Common, Booker T. Washington, Taraji P. Henson, Judge Kevin Ross, Langston Hughes, Katherine Johnson, Kenya Barris, and Vice President Kamala Harris, to name a few.
"The HBCU brand represents over 184 years of historic excellence, dating back to 1837, which helped cultivate some of the world's greatest minds and talent," said Byron Allen, Founder, Chairman and CEO of Allen Media Group. "HBCU GO and theGrio position our advertisers to speak to the heart and soul of Black America 24/7, and help our sponsors stay strongly connected with one of the most valuable, untapped audiences in the world."
For more information about HBCU GO visit HBCUGO.TV or follow us on Facebook, Twitter, YouTube, Instagram.
About HBCU GO
HBCU GO is a cultural lifestyle destination and leading sports media provider that embraces and represents the voice of Black Excellence every day of the year through an all-new platform that captures the rich history, diversity, perspectives, and cultural experiences at Historically Black Colleges and Universities (HBCUs). HBCU GO also provides a platform for emerging creatives in media production, branding, and broadcasting. We offer our viewers the best in live sports, original series, documentaries, films, comedy, and edutainment programming produced by African-American leading producers, directors, and students from select HBCUs.
Launched in 2012, the free-streaming service HBCU GO was purchased by Byron Allen in 2021 and is part of Byron Allen's Allen Media Group (AMG). AMG is headquartered in Los Angeles with offices in New York, Chicago, Atlanta, and Charleston, SC. AMG owns 27 ABC-NBC-CBS-FOX network affiliate broadcast television stations in 21 U.S. markets and twelve 24-hour HD television networks serving nearly 220 million subscribers: THE WEATHER CHANNEL, THE WEATHER CHANNEL EN ESPAÑOL, PETS.TV, COMEDY.TV, RECIPE.TV, CARS.TV, ES.TV, MYDESTINATION.TV, JUSTICECENTRAL.TV, THEGRIO, THIS TV, and PATTRN. AMG also owns the streaming platforms HBCU GO, THE GRIO STREAMING APP, SPORTS.TV, THE WEATHER CHANNEL STREAMING APP, and LOCAL NOW -- the free-streaming AVOD service powered by THE WEATHER CHANNEL and content partners, which delivers real-time, hyper-local news, weather, traffic, sports, and lifestyle information. For more information, visit www.entertainmentstudios.com and www.hbcugo.tv
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SOURCE Allen Media Group | https://www.ktre.com/prnewswire/2022/09/09/byron-allens-hbcu-gothe-grio-attracts-major-fortune-500-sponsors-historically-black-colleges-universities-sports-network/ | 2022-09-10T18:58:22 | en | 0.886214 |
TOKYO, Sept. 9, 2022 /PRNewswire/ -- KLab Inc., a leader in online mobile games, announced that its head-to-head football simulation game Captain Tsubasa: Dream Team will hold the FC Barcelona Official Campaign starting Friday, September 9th. During the campaign period, new players Tsubasa Ozora, Rivaul, Gordoba Gonzales, and Pedro Fonseca will debut wearing FC Barcelona official kits. See the original press release (https://www.klab.com/en/press/) for more information.
FC BARCELONA OFFICIAL CAMPAIGN Login Bonus
Login every day to the game during the event period to receive great rewards.
FC BARCELONA Selection Transfer
Rivaul, Gordoba Gonzales, and Pedro Fonseca wearing the FC BARCELONA official kit debut as new players in this Transfer.
FC BARCELONA OFFICIAL CAMPAIGN Daily Scenario
Users can complete these limited scenarios once a day during the event period. Clear the scenario to receive points and medals to exchange for amazing items.
FC BARCELONA OFFICIAL CAMPAIGN Event Mission
During the event period, complete the Event Missions to earn great rewards.
FC BARCELONA 2022/2023 Official Kits Added to Dreamball Exchange
The Dreamball Exchange is getting an update with the FC BARCELONA 2022/2023 home, away, GK uniforms. Users can exchange Dreamballs to collect them.
Overview of Captain Tsubasa: Dream Team
Supported OSes: Android™ 4.4+, iOS 10.0+, HarmonyOS 2.0+
Genre: Head-to-head football simulation game
Price: Free-to-play (In-app purchases available)
Supported Regions: Global (Excludes Japan and Mainland China)
Official Website: https://www.tsubasa-dreamteam.com/en
Official Twitter Account: @tsubasaDT_en
Official Facebook Page: https://www.facebook.com/tsubasaDTen
Official YouTube Channel: https://www.youtube.com/channel/UCTgOPO7kIQ35YzB7SBIQoWQ/
Official Discord Channel: https://discord.gg/6tyEs48
Copyright: ©Yoichi Takahashi/SHUEISHA
©Yoichi Takahashi/SHUEISHA/TV TOKYO/ENOKIFILM
© KLabGames
Download here:
App Store: https://itunes.apple.com/app/id1293738123
Google Play: https://play.google.com/store/apps/details?id=com.klab.captain283.global
AppGallery: https://appgallery.huawei.com/#/app/C105375049
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SOURCE KLab Inc. | https://www.ktre.com/prnewswire/2022/09/09/captain-tsubasa-dream-team-debuts-new-players-including-tsubasa-ozora-rivaul-wearing-official-fc-barcelona-uniforms/ | 2022-09-10T18:58:29 | en | 0.791378 |
NEW YORK, Sept. 9, 2022 /PRNewswire/ --
WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of Celsius Financial Products, including CEL Tokens, Earn Rewards high-interest accounts, and/or Celsius Loan products, between February 9, 2018, and June 13, 2022, inclusive (the "Class Period"), against Celsius Network LLC ("Celsius"), Celsius Lending LLC, Celsius KeyFi LLC (collectively, the "Celsius Entities") and its executives Alexander Mashinsky, Shlomi "Daniel" Leon, David Barse, and Alan Jeffrey Carr (together, "Defendants"), of the important September 13, 2022 lead plaintiff deadline.
SO WHAT: If you purchased Celsius Financial Products, including CEL Tokens, Earn Rewards high-interest accounts, and/or Celsius Loan products you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.
WHAT TO DO NEXT: To join the Celsius class action, go to https://rosenlegal.com/submit-form/?case_id=7586 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 13, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.
DETAILS OF THE CASE: According to the lawsuit, Defendants violated provisions of the Securities Act by selling non-exempt securities without registering it. The complaint alleges that Celsius and Individual Defendants violated provisions of the Securities Act by also participating in Celsius' failure to register the Celsius Financial Products. The complaint alleges that the Defendants violated provisions of the New Jersey Common Law by possessing the monetary value of Celsius Financial Products of inflated value which rightfully belongs to the Plaintiff and members of the Class.
Also according to the lawsuit, Defendants violated provisions of the Exchange Act by carrying out a plan, scheme, and course of conduct that Celsius intended to and did deceive retail investors and thereby caused them to purchase Celsius Financial Products at artificially inflated prices; endorsed false statements they knew or recklessly should have known were material misleading, and they made untrue statements of material fact and omitted to state material facts necessary to make the statements made not misleading.
To join the Celsius class action, go to https://rosenlegal.com/submit-form/?case_id=7586 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com
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SOURCE Rosen Law Firm, P.A. | https://www.ktre.com/prnewswire/2022/09/09/cel-final-deadline-alert-rosen-trusted-investor-counsel-encourages-celsius-investors-secure-counsel-before-important-september-13-deadline-securities-class-action-cel/ | 2022-09-10T18:58:36 | en | 0.910302 |
Acquisition Will Accelerate Growth Strategy
NEW YORK, Sept. 9, 2022 /PRNewswire/ -- Dominari Financial, Inc., the financial services subsidiary of AIkido Pharma Inc., (NASDAQ: AIKI) has entered into an exclusive agreement for the acquisition of a broker-dealer firm. This is Dominari's first acquisition since launching in June. Details of the proposed purchase can be found in the 8K on file with the SEC.
Dominari Financial was formed with the intention of acquiring revenue generating assets in the fintech and financial services industry. "Our goal has always been to move swiftly to execute a roll-up strategy of wealth management firms that cater to ultra-high-net worth investors. This transformative purchase not only accelerates our timetable, but also gives us the organizational infrastructure and technology needed to scale Dominari into a financial services powerhouse," said Carlos Aldavero, President of Dominari.
Kyle Wool, AIkido board member, acted as matchmaker on the deal and will continue to advise Mr. Aldavero on the purchase. "The board fully supports the diversification strategy of which Dominari Financial is the centerpiece," added Wool. "Once approved by FINRA, this acquisition will catapult Dominari forward and lays the groundwork for future acquisitions. I am looking forward to working closely with Carlos to continue to identify synergistic companies to bring into the portfolio," he continued.
Upon approval of the transaction by FINRA, this acquisition will allow Dominari Financial to provide banking and lending services through a collaborative agreement with a third-party institution, delivering the full balance sheet to UHNW investors, corporations, and institutional clients once the deal officially closes.
Dominari is a dynamic, forward-thinking financial services company that creates wealth for all stakeholders by capitalizing on emerging trends in the financial services sector and identifying early-stage future opportunities that will generate a high rate of return for investors.
AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company's filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
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SOURCE Dominari Financial, Inc. | https://www.ktre.com/prnewswire/2022/09/09/dominari-financial-inc-executes-definitive-agreement-buy-broker-dealer/ | 2022-09-10T18:58:43 | en | 0.95141 |
ALBUQUERQUE, N.M., Sept. 9, 2022 /PRNewswire/ -- The Board of Directors of Public Service Company of New Mexico, a subsidiary of PNM Resources (NYSE: PNM), declared the regular quarterly dividend of $1.145 per share on the 4.58 percent series of cumulative preferred stock. The preferred stock dividend is payable October 15, 2022 to shareholders of record at the close of business September 30, 2022.
PNM Resources (NYSE: PNM) is an energy holding company based in Albuquerque, N.M., with 2021 consolidated operating revenues of $1.8 billion. Through its regulated utilities, PNM and TNMP, PNM Resources provides electricity to approximately 800,000 homes and businesses in New Mexico and Texas. PNM serves its customers with a diverse mix of generation and purchased power resources totaling 3.1 gigawatts of capacity, with a goal to achieve 100% emissions-free energy by 2040. For more information, visit the company's website at www.PNMResources.com.
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SOURCE PNM Resources, Inc. | https://www.ktre.com/prnewswire/2022/09/09/public-service-company-new-mexico-declares-preferred-dividend/ | 2022-09-10T18:58:49 | en | 0.917723 |
BERWYN, Pa., Sept. 9, 2022 /PRNewswire/ -- RM LAW, P.C. announces that a class action lawsuit has been filed on behalf of all persons or entities that purchased Latch, Inc. ("Latch" or the "Company") (NASDAQ: LTCH) securities during the period from May 13, 2021 through August 25, 2022 inclusive (the "Class Period").
Latch shareholders may, no later than October 31, 2022, move the Court for appointment as a lead plaintiff of the Class. If you purchased shares of Latch and would like to learn more about these claims or if you wish to discuss these matters and have any questions concerning this announcement or your rights, contact Richard A. Maniskas, Esquire toll-free at (844) 291-9299 or to sign up online, click here.
According to the complaint, on or about June 3, 2021, Latch became a public entity via business combination with TSIA. On August 25, 2022, after the market closed, Latch revealed that it would restate financial statements for 2021 and the first quarter of 2022 due to revenue recognition errors related to the sale of hardware devices. Specifically, the Company stated that "certain revenue recognition errors occurred as a result of unreported sales arrangements due to sales activity that was inconsistent with the Company's internal controls and procedures." On this news, Latch's stock fell $0.13, or 12.2%, to close at $0.95 per share on August 26, 2022, on unusually heavy trading volume.
Throughout the Class Period, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, defendants failed to disclose to investors that there were unreported sales arrangements related to hardware devices that would result in the Company improperly recognizing revenue throughout fiscal 2021 and first quarter 2022. This material weakness in Latch's internal control over financial reporting related to revenue recognition required Latch to restate financial statements for fiscal 2021 and first quarter 2022.
If you are a member of the class, you may, no later than October 31, 2022, request that the Court appoint you as lead plaintiff of the class. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as "lead plaintiff." Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain RM LAW, P.C. or other counsel of your choice, to serve as your counsel in this action.
For more information regarding this, please contact RM LAW, P.C. (Richard A. Maniskas, Esquire) toll-free at (844) 291-9299 or by email at rm@maniskas.com or click here. For more information about class action cases in general or to learn more about RM LAW, P.C. please visit our website by clicking here.
RM LAW, P.C. is a national shareholder litigation firm. RM LAW, P.C. is devoted to protecting the interests of individual and institutional investors in shareholder actions in state and federal courts nationwide.
CONTACT: RM LAW, P.C.
Richard A. Maniskas, Esquire
1055 Westlakes Dr., Ste. 300
Berwyn, PA 19312
484-324-6800
844-291-9299
rm@maniskas.com
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SOURCE RM LAW, P.C. | https://www.ktre.com/prnewswire/2022/09/09/rm-law-announces-class-action-lawsuit-against-latch-inc/ | 2022-09-10T18:58:56 | en | 0.945633 |
You need to enable JavaScript to run this app. | https://sportspyder.com/nfl/tampa-bay-buccaneers/articles/40708303 | 2022-09-10T18:59:01 | en | 0.738227 |
You need to enable JavaScript to run this app. | https://sportspyder.com/nfl/tampa-bay-buccaneers/articles/40708351 | 2022-09-10T18:59:08 | en | 0.738227 |
BERWYN, Pa., Sept. 9, 2022 /PRNewswire/ -- RM LAW, P.C. announces that a class action lawsuit has been filed on behalf of all persons or entities that purchased Sema4 Holdings Corp. ("Sema4" or the "Company") (NASDAQ: SMFR) securities during the period from March 14, 2022 through August 15, 2022 inclusive (the "Class Period").
Sema4 shareholders may, no later than November 7, 2022, move the Court for appointment as a lead plaintiff of the Class. If you purchased shares of Sema4 and would like to learn more about these claims or if you wish to discuss these matters and have any questions concerning this announcement or your rights, contact Richard A. Maniskas, Esquire toll-free at (844) 291-9299 or to sign up online, click here.
According to the complaint, on August 15, 2022, the Company announced changes to its research and development leadership team, including that Eric Schadt was stepping down from his roles as President and Chief R&D Officer. The Company also disclosed that it was eliminating approximately 13% of its workforce as part of a series of restructuring and corporate realignments. During the related conference call, Sema4 revealed that it had "reversed $30.1 million of revenue this quarter related to prior periods," in connection with negotiations with "one of [Sema4's] larger commercial payors regarding the potential recoupment of payments for Sema4 carrier screening services rendered from 2018 to early 2022." On this news, Sema4's stock fell $0.80, or 33.3%, to close at $1.60 per share on August 16, 2022.
If you are a member of the class, you may, no later than November 7, 2022, request that the Court appoint you as lead plaintiff of the class. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as "lead plaintiff." Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain RM LAW, P.C. or other counsel of your choice, to serve as your counsel in this action.
For more information regarding this, please contact RM LAW, P.C. (Richard A. Maniskas, Esquire) toll-free at (844) 291-9299 or by email at rm@maniskas.com or click here. For more information about class action cases in general or to learn more about RM LAW, P.C. please visit our website by clicking here.
RM LAW, P.C. is a national shareholder litigation firm. RM LAW, P.C. is devoted to protecting the interests of individual and institutional investors in shareholder actions in state and federal courts nationwide.
CONTACT:
RM LAW, P.C.
Richard A. Maniskas, Esquire
1055 Westlakes Dr., Ste. 300
Berwyn, PA 19312
484-324-6800
844-291-9299
rm@maniskas.com
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BERWYN, Pa., Sept. 9, 2022 /PRNewswire/ -- RM LAW, P.C. announces that a class action lawsuit has been filed on behalf of all persons or entities that purchased TuSimple Holdings, Inc. ("TuSimple" or the "Company") (NASDAQ: TSP) securities during the period from April 15, 2021 through August 1, 2022 inclusive (the "Class Period").
TuSimple shareholders may, no later than October 31, 2022, move the Court for appointment as a lead plaintiff of the Class. If you purchased shares of TuSimple and would like to learn more about these claims or if you wish to discuss these matters and have any questions concerning this announcement or your rights, contact Richard A. Maniskas, Esquire toll-free at (844) 291-9299 or to sign up online, click here.
According to the complaint, on April 15, 2021, TuSimple effected its IPO, selling 33.8 million class A common shares at $40.00 per share, generating $1.031 billion in gross proceeds. On August 1, 2022, the Wall Street Journal published an article titled "Self-Driving Truck Accident Draws Attention to Safety at TuSimple," which brought to light a number of previously undisclosed concerns that undermined defendants' representations and omissions concerning the Company's safety. The article referenced an April 6, 2022, accident involving a truck fitted with TuSimple's autonomous driving technology, noting that regulators disclosed the accident to the public in June after TuSimple filed a report on the incident, which "underscores concerns that the autonomous-trucking company is risking safety on public roads in a rush to deliver driverless trucks to market, according to independent analysts and more than a dozen of the company's former employees." On this news, the Company's share fell be almost 10%, to close at $8.99 per share on August 1, 2022.
The Registration Statement in support of the IPO failed to disclose, inter alia, that: (i) TuSimple's commitment to safety was significantly overstated and defendants concealed fundamental problems with the Company's technology; (ii) TuSimple was rushing the testing of its autonomous driving technology in order to deliver driverless trucks to the market ahead of its more safety-conscious competitors; (iii) there was a corporate culture within TuSimple that suppressed or ignored safety concerns in favor of unrealistically ambitious testing and delivery schedules; (iv) the aforementioned conduct made accidents involving the Company's autonomous driving technology more likely; (v) and the aforementioned conduct invited enhanced regulatory scrutiny and investigatory action toward the Company.
If you are a member of the class, you may, no later than October 31, 2022, request that the Court appoint you as lead plaintiff of the class. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as "lead plaintiff." Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain RM LAW, P.C. or other counsel of your choice, to serve as your counsel in this action.
For more information regarding this, please contact RM LAW, P.C. (Richard A. Maniskas, Esquire) toll-free at (844) 291-9299 or by email at rm@maniskas.com or click here. For more information about class action cases in general or to learn more about RM LAW, P.C. please visit our website by clicking here.
RM LAW, P.C. is a national shareholder litigation firm. RM LAW, P.C. is devoted to protecting the interests of individual and institutional investors in shareholder actions in state and federal courts nationwide.
CONTACT: RM LAW, P.C.
Richard A. Maniskas, Esquire
1055 Westlakes Dr., Ste. 300
Berwyn, PA 19312
484-324-6800
844-291-9299
rm@maniskas.com
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NEW YORK, Sept. 9, 2022 /PRNewswire/ --
WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Co-Diagnostics, Inc. (NASDAQ: CODX) between May 12, 2022 and August 11, 2022, both dates inclusive (the "Class Period"), of the important October 17, 2022 lead plaintiff deadline.
SO WHAT: If you purchased Co-Diagnostics securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.
WHAT TO DO NEXT: To join the Co-Diagnostics class action, go to https://rosenlegal.com/submit-form/?case_id=8137 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than October 17, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.
DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) there was significant falloff in demand of Co-Diagnostics' Logix Smart™ COVID-19 Test as demand for the tests plummeted throughout the quarter ended June 30, 2022; and (2) as a result, defendants' positive statements about the demand for its Logix Smart™ COVID-19 Test lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.
To join the Co-Diagnostics class action, go to https://rosenlegal.com/submit-form/?case_id=8137 mailto:or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com
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NEW YORK, Sept. 9, 2022 /PRNewswire/ -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Carvana Co. (NYSE: CVNA) between May 6, 2020 and June 24, 2022, both dates inclusive (the "Class Period"), of the important October 3, 2022 lead plaintiff deadline in the securities class action commenced by the firm.
SO WHAT: If you purchased Carvana securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.
WHAT TO DO NEXT: To join the Carvana class action, go to https://rosenlegal.com/submit-form/?case_id=6457 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than October 3, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.
DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Carvana faced serious, ongoing issues with documentation, registration, and title with many of its vehicles; (2) as a result, Carvana was issuing unusually frequent temporary plates; (3) as a result of the foregoing, Carvana was violating laws and regulations in many existing markets; (4) as a result of the foregoing, Carvana risked its ability to continue business and/or expand its business in existing markets; (5) as a result of the foregoing, Carvana was at an increased risk of governmental investigation and action; (6) Carvana was in discussion with state and local authorities regarding the above-stated business tactics and issues; (7) Carvana was facing imminent and ongoing regulatory actions including license suspensions, business cessation, and probation in several states and counties including in Arizona, Illinois, Pennsylvania, Michigan, and North Carolina; and (8) as a result, defendants' statements about Carvana's business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
To join the Carvana class action, go https://rosenlegal.com/submit-form/?case_id=6457 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com
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NEW YORK, Sept. 9, 2022 /PRNewswire/ --
WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of 17 Education & Technology Group Inc. (NASDAQ: YQ) pursuant and/or traceable to the registration statement and related prospectus (collectively, the "Registration Statement") issued in connection with 17EdTech's December 2020 initial public offering (the "IPO"), of the important September 19, 2022 lead plaintiff deadline, in the securities class action commenced by the Firm.
SO WHAT: If you purchased 17EdTech securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.
WHAT TO DO NEXT: To join the 17EdTech class action, go to https://rosenlegal.com/submit-form/?case_id=7395 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 19, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.
DETAILS OF THE CASE: According to the lawsuit, the IPO Registration Statement featured false and/or misleading statements and/or failed to disclose that: (1) Defendant 17EdTech's K-12 Academic AST Services would end less than a year after the IPO; (2) as part of its ongoing regulatory efforts, Chinese authorities would imminently curtail and/or end 17EdTech's core business; and (3) as a result, Defendants' statements about the Company's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
To join the 17EdTech class action, go to https://rosenlegal.com/submit-form/?case_id=7395 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com
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SOURCE Rosen Law Firm, P.A. | https://www.ktre.com/prnewswire/2022/09/09/yq-final-deadline-alert-rosen-trusted-leading-law-firm-encourages-17-education-amp-technology-group-inc-investors-secure-counsel-before-important-september-19-deadline-securities-class-action-filed-by-firm-yq/ | 2022-09-10T18:59:35 | en | 0.914473 |
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NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- ClaimsFiler, a FREE shareholder information service, reminds investors that they have until October 31, 2022 to file lead plaintiff applications in a securities class action lawsuit against Abbott Laboratories (NYSE: ABT), if they purchased the Company's shares between February 19, 2021 to June 8, 2022, inclusive (the "Class Period"). This action is pending in the United States District Court for the Northern District of Illinois.
Abbott investors should visit us at https://claimsfiler.com/cases/nyse-abt-1/ or call toll-free (844) 367-9658. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
Abbott and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
On February 17, 2022, the U.S. Food and Drug Administration ("FDA") announced that its inspection of the Company's Sturgis, Michigan facility, prompted by consumer complaints of infant illness, had yielded several positive contamination results for the Cronobacter sakazakii bacteria, linked to infant illnesses and death. On the same day, the Company, without mention of the FDA investigation, recalled certain infant formula products, including the popular brands Similac, Alimentum and EleCare, all manufactured in Sturgis. On this news, shares of Abbott declined by $3.79 per share, or 3.14%.
Then, on March 22, 2022, the FDA reported that, although not "final FDA determinations," its most recent inspection conducted between January 31, 2022 and March 18, 2022 revealed that the Company failed to establish process controls "designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment" and failed to "ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source." On this news, shares of Abbott declined by an additional $4.97 per share, or 4%.
Finally, on June 8, 2022, it was reported that a whistleblower complaint identifying numerous serious examples of misconduct at Sturgis related to the above had been filed with the U.S. Occupational Safety & Health Administration ("OSHA") in February 2021, and that OSHA had delivered that complaint to Abbott Laboratories and the FDA during the same month. On this news, shares of Abbott declined by an additional 3.5%, further damaging investors.
The case is Pembroke Pines Firefighters & Police Officers Pension Fund v. Abbott Laboratories, No. 22-cv-04661.
ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. At ClaimsFiler.com, investors can: (1) register for free to gain access to information and settlement websites for various securities class action cases so they can timely submit their own claims; (2) upload their portfolio transactional data to be notified about relevant securities cases in which they may have a financial interest; and (3) submit inquiries to the Kahn Swick & Foti, LLC law firm for free case evaluations.
To learn more about ClaimsFiler, visit www.claimsfiler.com.
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AUBURN, Ala., Sept. 10, 2022 /PRNewswire/ -- Auburn University has launched its 2022 public service announcement, or PSA, spotlighting how it is advancing student success through experiential learning.
The PSA, titled "How we do it," was unveiled on Auburn's social media feeds and its PSA website—www.auburn.edu/howwedoit. The NCAA commercial focuses on how the Auburn Family teaches, learns and lives, with students experiencing real-world applications through hands-on work in the fields of their desired profession as well as through outreach and research opportunities.
"As our PSA states, what makes Auburn so special is hard to put into words," said John Morris, Auburn's senior vice president for Advancement. "You just have to experience it, and our students do just that—through sports broadcasts to investment labs, forestry work, design studios and even partnerships that reach the stretches of outer space. Our students are learning the lessons that lead to success and the betterment of our community and beyond."
Among the highlights of the PSA is Auburn's War Eagle Productions program—through which journalism students gain professional training in live sports production. The commercial also features Auburn's motion-base virtual reality flight simulators, as well as a partnership between Auburn's Samuel Ginn College of Engineering and Boeing that allows undergraduate students hands-on, real-world design experience on groundbreaking aerospace projects involving NASA and the U.S. Air Force. In the way of research, the PSA spotlights the College of Veterinary Medicine's recent awarding of a $24 million contract by the U.S. Department of Homeland Security Science and Technology Directorate to advance detection canine sciences and enhance operational threat detection capabilities.
Similarly, the PSA's website notes several other student experiential learning opportunities, including a summer practicum through Auburn's College of Forestry, Wildlife and Environment; a student-run free clinic in Mobile affiliated with the Harrison College of Pharmacy and the University of South Alabama; the new Tony and Libba Rane Culinary Science Center that opened this fall as the home for the College of Human Sciences' School of Hospitality Management; collaboration opportunities in Auburn's Radio-Frequency Identification Lab; the Harbert College of Business' Integrated Financial Leadership Program; and the College of Architecture, Design and Construction's Futures Studio in Mobile.
For more information about the many ways in which Auburn is leading student success and what makes the Auburn experience so special, visit auburn.edu.
Auburn University is a nationally ranked land grant institution recognized for its commitment to world-class scholarship, interdisciplinary research with an elite, top-tier Carnegie R1 classification, life-changing outreach with Carnegie's Community Engagement designation and an undergraduate education experience second to none. Auburn is home to more than 30,000 students, and its faculty and research partners collaborate to develop and deliver meaningful scholarship, science and technology-based advancements that meet pressing regional, national and global needs. Auburn's commitment to active student engagement, professional success and public/private partnership drives a growing reputation for outreach and extension that delivers broad economic, health and societal impact.
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NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- ClaimsFiler, a FREE shareholder information service, reminds investors that they have until October 31, 2022 to file lead plaintiff applications in a securities class action lawsuit against Azure Power Global Limited ("Azure" or the "Company") (NYSE: AZRE), if they purchased the Company's securities between June 15, 2021 and August 26, 2022, inclusive (the "Class Period"). This action is pending in the United States District Court for the Southern District of New York.
Get Help
Azure investors should visit us at https://claimsfiler.com/cases/nyse-azre/ or call toll-free (844) 367-9658. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
About the Lawsuit
Azure and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
On August 29, 2022, the Company disclosed that its Chief Executive Officer had resigned, less than two months after his appointment and that it had "received a whistleblower complaint in May 2022 alleging potential procedural irregularities and misconduct by certain employees at a plant belonging to one of its subsidiaries." During the Company's review of these allegations, Azure "discovered deviations from safety and quality norms" and "also identified evidence of manipulation of project data and information by certain employees."
On this news, shares of Azure declined by $4.61 per share, or approximately 44.07%, from $10.46 per share to close at $5.85 on August 29, 2022.
The case is Gilbert v. Azure Power Global Limited, No. 22-cv-7432.
About ClaimsFiler
ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. At ClaimsFiler.com, investors can: (1) register for free to gain access to information and settlement websites for various securities class action cases so they can timely submit their own claims; (2) upload their portfolio transactional data to be notified about relevant securities cases in which they may have a financial interest; and (3) submit inquiries to the Kahn Swick & Foti, LLC law firm for free case evaluations.
To learn more about ClaimsFiler, visit www.claimsfiler.com.
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Ministry Marks the Successful Start of Global Sales and Marketing Missions
FORT LAUDERDALE, Fla., Sept. 10, 2022 /PRNewswire/ -- The Bahamas Ministry of Tourism, Investments & Aviation (BMOTIA) this week, 7 September, hosted the first in a series of Global Sales and Marketing Missions at venues across Fort Lauderdale designed to further promote The Bahamas as a leading tourism destination and paved a path towards continued tourism recovery.
A delegation led by the Honourable I. Chester Cooper, Deputy Prime Minister and Minister of Tourism, Investments & Aviation, participated in a lineup of productive meetings with key stakeholders from across the tourism industry, culminating in a culturally-inspired evening event at the Broward Center for The Performing Arts in Fort Lauderdale.
During a tour of the newly named Little Bahamas of Coconut Grove, DPM Cooper was presented with a key to the City of Miami by Congresswoman Fredricka Wilson — a Bahamian descendent leading the charge to preserve the history and contribution of Bahamians, who were the city's first settlers.
Joined by destination representatives, hotel partners and BMOTIA executives, DPM Cooper and Acting Director General, Latia Duncombe, hosted 150 sales representatives and industry partners and some 20 media and influencers at the evening event. Guests were transported to The Bahamas via picturesque digital displays of the beautiful Bahama islands, promotional videos highlighting the offerings of the 16 island destinations, a three-course sit down dinner featuring a Bahamian inspired menu, and an electrifying Junkanoo performance. A live Q+A panel highlighted The Bahamas' steadily growing tourism numbers for key industry leaders, sales and trade representatives, stakeholders and media in attendance.
"All of our markets are critical to our success as we strive to reach pre-pandemic tourism arrivals," said Duncombe.
"We have daily airlift coming from Florida and it's extremely important for us to show how easy it is to get to and through the islands of The Bahamas. Whether it's boating fishing, diving, or the MICE market, there are significant opportunities here in Florida — just 50 miles away. We are reengaging our trade and media partners as part of our strategy to double stopover visitors across our 16 island destinations.
"We know it's not always possible for key industry sales and media representatives to visit our beautiful islands -- so it is important for us to bring a taste of The Bahamas directly to them to ensure the destination remains top of mind in a very competitive landscape."
The series of events will continue onto Orlando, Florida, 8 Sept., followed by New York City, New York, later this month. Further stops in North America include Atlanta, Georgia; Houston, Texas; Charlotte, North Carolina; and Los Angeles, California, followed by cities across Canada.
In addition to major travel hubs throughout the U.S. and Canada, the delegation will be heading to Brazil, and the United Arab Emirates to bring a taste of Bahamian culture directly to key international markets across the globe to inspire travel to the destination.
ABOUT THE BAHAMAS
The Bahamas has over 700 islands and cays, as well as 16 unique island destinations. Located only 50 miles off the coast of Florida, it offers a quick and easy way for travellers to escape their everyday. The island nation also boasts world-class fishing, diving, boating and thousands of miles of the Earth's most spectacular beaches for families, couples and adventurers to explore. See why It's Better in The Bahamas at www.bahamas.com or on Facebook, YouTube or Instagram.
PRESS INQUIRIES
Anita Johnson-Patty
Director, Global Communications
Bahamas Ministry of Tourism & Aviation
ajohnson@bahamas.com
Weber Shandwick
Public Relations
Bahamas@webershandwick.com
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NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC ("KSF"), announces that KSF continues its investigation into BioMarin Pharmaceutical Inc. (NasdaqGS: BMRN).
On August 19, 2020, the Company disclosed that it received a Complete Response Letter ("CRL") from the FDA rejecting its Biologics License Application ("BLA") for its product, valoctocogene roxaparvovec, and recommending two years of data from the Company's ongoing 270-301 study (Phase 3) and that the Company "complete the Phase 3 Study and submit two-year follow-up safety and efficacy data on all study participants," thus requiring a lengthier study before approval would be considered.
Thereafter, the Company and certain of its executives were sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period, violating federal securities laws. Recently, the court presiding over the case denied the Company's motion to reconsider the court's decision denying in part the Company's motion to dismiss, allowing the case to move forward.
KSF's investigation is focusing on whether BioMarin's officers and/or directors breached their fiduciary duties to BioMarin's shareholders or otherwise violated state or federal laws.
If you have information that would assist KSF in its investigation, or have been a long-term holder of BioMarin shares and would like to discuss your legal rights, you may, without obligation or cost to you, call toll-free at 1-877-515-1850 or email KSF Managing Partner Lewis Kahn (lewis.kahn@ksfcounsel.com), or visit https://ksfcounsel.com/cases/biomarin-pharmaceutical-inc-nasdaqgs-bmrn/ to learn more.
KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation's premier boutique securities litigation law firms. KSF serves a variety of clients – including public institutional investors, hedge funds, money managers and retail investors – in seeking to recover investment losses due to corporate fraud and malfeasance by publicly traded companies. KSF has offices in New York, California, Louisiana and New Jersey.
To learn more about KSF, you may visit www.ksfcounsel.com.
Contact:
Kahn Swick & Foti, LLC
Lewis Kahn, Managing Partner
lewis.kahn@ksfcounsel.com
1-877-515-1850
1100 Poydras St., Suite 3200
New Orleans, LA 70163
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Proposal to add more beneficiaries comes as Army veteran accepts milestone 300th home
NORTHLAKE, Texas, Sept. 10, 2022 /PRNewswire/ -- Building Homes for Heroes, a nonprofit that for 16 years has provided mortgage-free homes to military veterans, announced today it is seeking to expand the nationwide program to police, firefighters and other emergency first responders.
The move to expand its mission to support first responders - a decision unveiled the day before the anniversary of the 9/11 terrorist attacks - came as the organization marked a milestone 300th home, gifted to Army veteran Jonathan Merchant. He had just returned from service in Bosnia when he suffered a quadriplegic spinal cord injury in a car accident.
Merchant, an Army specialist stationed at Texas' Fort Hood, has not let that 1999 crash define him. Doctors told him if he survived, he could not expect to be self-sufficient and would have a limited life. Instead, he regained some feeling in his arms, becoming a competitive cyclist, swimmer and triathlete.
He was the first quadriplegic to finish the half ironman distance in a race sponsored by Challenged Athletes Foundation and he regularly takes part in similar events. A certified life coach, he now seeks to inspire others facing adversity.
Building Homes for Heroes founder, businessman Andy Pujol, said the courage and sacrifice of veterans is inspirational – as has been the work and dedication to community by emergency first responders. Adding that group to the program reflects the organization's commitment to honoring those who serve their country.
The organization, incorporated in New York, filed its plans to expand the home program with the state attorney general's Charities Bureau. While Building Homes for Heroes cannot currently accept donations to benefit first responders, it expects to receive state approval soon, allowing fundraising for the new program by the end of the year.
"Our goal will always still be to gift, modify and construct one home, every 11 days, on average," Pujol said. "That will never change. But our organization was founded with the goal of supporting our heroes who sacrificed so much to defend our freedom. That relates to not only our nation's veterans, but also our heroic police officers, firefighters and other emergency first responders who proudly don their uniform and risk all to keep us safe."
Next year, Building Homes for Heroes hopes to gift its 343rd home around Sept. 11, 2023, in honor of the 343 members of the New York City Fire Department who died on Sept. 11, 2001.
At Saturday's ceremony, Merchant, 45, and his wife, Stephanie received an ADA-modified, four-bedroom, three-bathroom home constructed by award-winning Texas homebuilder Highland Homes in partnership with Hillwood, a Perot company.
Situated in Pecan Square, a Hillwood Communities development in Northlake, it is the second home in the Building Homes for Heroes' campaign, for the fifth consecutive year, to gift, modify and construct 11 homes in 11 weeks, marking the anniversary of Sept. 11 and Veterans Day.
"This unbelievable gift is more than just a home," Merchant said. "It's the freedom financially to start a family, physically to be able to grow our family. It's the key to making dreams in our heart come to fulfillment and doing for us something we couldn't do on our own."
Merchant retired from the Army after three years of service. He received many honors, including the Army Achievement Medal, NATO Medal, Hero of the Liberation Award, the Basic Training Badge and the Expert Infantry Badge.
After the ceremony, a celebration is scheduled within Pecan Square for the entire community in recognition of Building Homes for Heroes' 300th home. Pujol, Perot and other dignitaries will be in attendance.
Building Homes for Heroes
Building Homes for Heroes builds and gifts mortgage-free homes, and completes home modifications, for veterans and their families, and provides further services along their road to recovery to help them live a promising and fulfilling life ahead. The organization said 95.19% of every dollar donated in 2021 went directly to its mission, the 10th straight year reaching a program rating of at least 93%. It also received a perfect 4-star rating from Charity Navigator for six straight years, including a 100% in transparency and accountability. See www.buildinghomesforheroes.org.
Hillwood
Hillwood, a Perot company, is a premier commercial and residential real estate developer, investor and advisor of properties throughout North America and Europe. With a diverse portfolio of properties and home to many of the world's leading companies, Hillwood is committed to bringing long-term value to our customers, partners and the communities we serve. Through its Communities division, Hillwood has delivered nearly 40,000 single-family lots in 103 master-planned communities across 13 states. These communities continue to raise the bar in terms of quality, innovation, and the unmistakable sense of community that sets each property apart. See www.hillwoodcommunities.com
Highland Homes
Founded in 1985, Highland Homes is an employee-owned company that builds nearly 4,000 homes across Texas each year and is among the largest and most trusted single-family new home builders in the country. A commitment to excellence has earned the company many industry awards, including consistent high rankings by J.D. Power and Associates. See highlandhomes.com
Media contact:
Briana Herrington
Hill+Knowlton Strategies
briana.herrington@hkstrategies.com
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- This is the first positive pivotal trial to show survival benefits with a PD-1 inhibitor plus an anti-angiogenic tyrosine kinase inhibitor for unresectable hepatocellular carcinoma (uHCC)
- Combination therapy has the potential to offer a new treatment option for patients with uHCC, a condition with an urgent medical need
- Hengrui anticipates submission of an FDA Biologic License Application for camrelizumab as a treatment option for HCC soon
PARIS, Sept. 10, 2022 /PRNewswire/ -- Jiangsu Hengrui Pharmaceuticals Co., Ltd., one of the largest biopharmaceutical companies headquartered in China, today announced top-line results from the phase 3 study of camrelizumab (anti-PD1 checkpoint inhibitor) combined with rivoceranib (apatinib) vs. sorafenib as a first-line therapy for uHCC. Camrelizumab plus rivoceranib significantly prolonged overall survival (OS) and progression-free survival (PFS), and improved overall response rate (ORR) vs. sorafenib, a standard first-line treatment for uHCC.
The study is a multinational, randomized, open-label trial and included 543 patients from 13 countries. The study was initiated in June 2019, and met the primary endpoint in April 2022. Top-line data shown below were included in the presentation at the Congress of the European Society for Medical Oncology (ESMO).
- Median OS for camrelizumab + rivoceranib was 22.1 mos. [95% CI 19.1-27.2] vs. 15.2 mos. [13.0-18.5]; hazard ratio (HR) 0.62 [95% CI 0.49-0.80]; 1-sided p<0.0001,
- Median PFS for camrelizumab + rivoceranib was 5.6 mos. [95% CI 5.5-6.3] vs. 3.7 mos. [2.8-3.7]; HR 0.52 [95% CI 0.41-0.65]); 1-sided p<0.0001,
- Confirmed ORR for camrelizumab + rivoceranib was 25.4% (95% CI 20.3-31.0), compared to 5.9% (3.4-9.4) for sorafenib.
"We and others have established the validity of immune-checkpoint inhibition for the treatment of HCC. The combination of camrelizumab plus rivoceranib phase 3 trial results demonstrate the combo treatment as a new first-line treatment option for uHCC," said Dr. Lianshan Zhang, president of global R&D, Board Director of Hengrui Pharma. "We continue to work with our partner Elevar to bring this combination therapy to HCC patients around the world who could be benefited by this new treatment option."
"The results from this large multinational, randomized phase 3 study confirmed the robust progression-free survival and overall survival benefit in the first line of uHCC patient population and confirmed our understanding of the clinical benefit this combination therapy may offer patients with uHCC. With the solid and consistent data shown not only in ITT population but also in each subgroup population, we are looking forward to providing a new treatment option for uHCC patients!" said Amily Zhang, Vice President, Chief Medical Officer (Oncology) of Hengrui Pharma.
The findings were presented on September 10 during the annual ESMO in Paris.
"Camrelizumab (C) plus rivoceranib (R) vs. sorafenib (S) as first-line therapy for unresectable hepatocellular carcinoma (uHCC): a randomized, phase 3 trial" was shared as a late-breaking proffered paper presentation at ESMO on September 10, 8:40 a.m. – 8:50 a.m. CEST, location 7.1C – Cannes Auditorium. The session title is Proffered Paper Session 1: GI, upper digestive.
About SHR-1210-III-310 Trial
The SHR-1210-III-310 study (ClinicalTrials.gov, NCT03764293) is a randomized, open-label, phase 3 trial conducted in 95 study sites across 13 countries/regions to investigate the efficacy and safety of camrelizumab plus rivoceranib versus sorafenib as first-line therapy in patients with incurable, locally advanced or metastatic HCC who had not received previous systematic treatment. The primary endpoints were overall survival and progression-free survival as assessed by the blinded independent review committee according to Response Evaluation Criteria in Solid Tumors version 1.1. A total of 543 patients were randomized 1:1 to receive camrelizumab (200 mg intravenously once every two weeks) plus rivoceranib (250 mg orally once daily) or sorafenib (400 mg orally twice daily). This study was sponsored by Hengrui Pharma and co-funded by Elevar Therapeutics.
About Hepatocellular Carcinoma (HCC)
HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.
About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer etc.) and treatment settings.
Camrelizumab, under the brand name AiRuiKa®, is currently approved for 8 indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin's lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. FDA granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021. In April 2020, Hengrui Pharma licensed the Korean rights of camrelizumab to CrystalGenomics Inc., a biotech company based in the Republic of Korea.
About Rivoceranib (apatinib)
Rivoceranib (Apatinib) is the first small-molecule tyrosine kinase inhibitor (TKI) approved in gastric cancer in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is co-developed by Hengrui Pharma in China and by Elevar Therapeutics, Inc. globally (excluding China). It has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Clinical studies are ongoing in multiple solid tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (HCC) (in combination with camrelizumab), adenoid cystic carcinoma (as monotherapy) and colorectal cancer (in combination with Lonsurf®). Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in HCC (U.S.). Elevar holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Hengrui Pharma, under the brand name Aitan®.
About Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Hengrui Pharma is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma ranked the 24th among the top 1,000 global pharma companies in 20211. Hengrui has been on the Pharma Exec's annual listing of the top global pharmaceutical companies for the fourth consecutive year, rising from the 47th in 2019 to the 32nd in 20222.
1. https://torreya.com/publications/pharma-1000-report-torreya-2021-11-08.pdf.
2. https://www.pharmexec.com/view/2022-pharm-exec-top-50-companies
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Durable responses to treatment, with a median duration of response (mDoR) of 11.7 months, reported in Phase 1b/2 clinical trial of onvansertib plus FOLFIRI/bevacizumab in second-line KRAS-mutated mCRC
Observed mDoR is supported by preclinical findings that demonstrate onvansertib in combination with irinotecan can overcome intrinsic and refractory resistance to irinotecan in patient-derived xenograft models
Patients with a ≥90% decrease in KRAS mutant allele frequency (MAF), a response biomarker, in the first cycle of treatment had significantly higher ORR and longer PFS in Phase 1b/2 trial and an Expanded Access Program (EAP)
SAN DIEGO, Sept. 10, 2022 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced new preclinical and clinical data from its program in KRAS-mutated mCRC. The data are featured in two posters being presented at the European Society for Medical Oncology (ESMO) Congress 2022, which is taking place at the Paris Expo Porte de Versailles in Paris, France, and virtually.
Poster 397P: Early Decreases in KRAS Mutant Allele Frequency (MAF) Predict Clinical Benefit to the PLK1 Inhibitor Onvansertib in Combination with FOLFIRI/bev in 2L Treatment of Metastatic Colorectal Carcinoma (mCRC)
Poster 397P includes updated data (data cut-off date: July 25, 2022), as well as the results of correlative biomarker analyses from a Phase 1b/2 clinical trial of onvansertib plus FOLFIRI/bevacizumab in second-line KRAS-mutated mCRC. Measures of clinical response were compared between subsets of patients defined as KRAS responders or non-responders. KRAS responders were defined as patients with a ≥90% decrease in KRAS mutant allele frequency (MAF) in circulating tumor DNA (ctDNA) after one treatment cycle.
"The data from this trial show onvansertib plus FOLFIRI and bevacizumab outperforming historical controls on multiple key endpoints and are highly encouraging," said Heinz-Josef Lenz, MD, FACP, professor of medicine at USC Norris Comprehensive Cancer Center and the trial's principal investigator. "They suggest trial participants with various KRAS mutations experience durable clinical benefits and that the onvansertib-FOLFIRI combination is avoiding the mechanisms that typically drive rapid acquired resistance to the standard-of-care (SoC). This highlights onvansertib's potential to fill a crucial gap in mCRC's therapeutic paradigm, as there are currently limited options available for second line patients. In addition, the significant increases between response rates and progression-free survival in KRAS responders point to changes in MAF as a potential blood-based biomarker that could aid in treatment decisions."
Key data and conclusions presented in the poster include:
Overall response rate (ORR) and median progression-free survival (mPFS) reported in Phase 1b/2 trial substantially exceed those reported in historical control trials
- ORR across all evaluable patients was 35%, with 17 of 48 evaluable patients achieving an objective response and responses have been observed across multiple KRAS variants
- Median duration of response (mDoR) across all evaluable patients was 11.7 months (95% confidence interval (CI): 8.9 – not reached)
- mPFS across all evaluable patients was 9.3 months (95% CI: 7.6 – 13.5)
- Historical control trials of different drug combinations, including the standard-of-care (SOC) of FOLFIRI with bevacizumab, in similar patient populations have shown ORR and mPFS of 5 – 13% and ~4.5 – 5.7 months, respectively1-4
KRAS responders showed significantly greater ORR and mPFS compared to non-responders
- ORR in KRAS responders vs. KRAS non-responders: 63.6% (14/22) vs. 8.7% (2/23) (p = 0.00014)
- mPFS in KRAS responders vs. KRAS non-responders: 12.6 months vs. 6.0 months (p=0.019)
Poster 366P: The PLK1 Inhibitor Onvansertib Overcomes Irinotecan Resistance in RAS-mutated Metastatic Colorectal Cancer (mCRC) In Vivo and in Patients
Poster 366P includes findings (as of August 5, 2022) from Cardiff Oncology's EAP of onvansertib in KRAS-mutated mCRC, as well as data from murine studies evaluating onvansertib in combination with irinotecan in 6 PDX models of irinotecan-resistant, RAS-mutated CRC. Clinical findings reported in the Expanded Access Program (EAP) were compared between KRAS responders and non-responders. To enroll in the EAP, a patient must have been ineligible for the Phase 1b/2 clinical trial having received prior treatment with irinotecan or failed or progressed on multiple prior lines of standard-of-care therapy. EAP patients are treated with the same treatment regimen (onvansertib 15 mg/m2 plus FOLFIRI and bevacizumab) and dosing schedule as patients in the Phase 1b/2 clinical trial.
Scott Kopetz, MD, PhD, FACP, professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center commented, "Currently available third-line or later treatment options for patients are severely limited, due in large part to the high prevalence of tumors that show resistance to irinotecan. Based on the findings being presented at ESMO, combining onvansertib with the current SOC appears to be an innovative strategy that can overcome irinotecan resistance and address a broad and pressing unmet need. This hypothesis is further supported by onvansertib's mechanism of action, which targets DNA damage repair pathways underlying resistance to irinotecan and other chemotherapeutic agents."
Key findings and conclusions presented in the poster include:
EAP patients with prior irinotecan treatment (43 out of a total of 51 EAP patients) showed clinical benefit following treatment with onvansertib plus FOLFIRI/bevacizumab
- mPFS was 4.04 months (95% CI: 2.96 – 8.38); 6-month PFS rate was 37.3% (95% CI: 24.9 – 55.8)
Of EAP patients with prior irinotecan treatment, KRAS responders had significantly longer PFS compared to non-responders.
- mPFS in KRAS responders vs. KRAS non-responders: 11.18 months vs. 3.25 months (p=0.0014)
The combination of onvansertib and irinotecan showed significantly greater anti-tumor activity compared to onvansertib monotherapy in 5 of 6 tested PDX models of irinotecan-resistant, RAS-mutated CRC.
The ESMO posters are currently available for viewing on the congress's virtual platform and will also be presented by Drs. Lenz and Kopetz during Poster Sessions 8 and 7, respectively, on September 11, 2022. Following the congress, the posters will be available on the "Scientific Presentations" section of the Cardiff Oncology website at https://cardiffoncology.com/scientific-presentations/.
Clinical and Corporate Update Conference Call and Webcast
Cardiff Oncology will host a webcast and conference call to provide a clinical and corporate update to the investment community on Monday, September 12, 2022 at 4:30 PM ET. The event will feature discussions on the planned development pathway for onvansertib in KRAS-mutated metastatic colorectal cancer and updates on other development programs. In addition, company management will provide data updates from ongoing clinical trials. To access the call, please dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) and refer to conference ID 13731618. The conference call will also be webcast live and a link to the webcast can be accessed here. A replay of the webcast will be available by visiting the "Events" section of the Cardiff Oncology website after its conclusion.
About the Phase 1b/2 Trial of Onvansertib in the Second-Line Treatment of KRAS-mutated mCRC
This is a multi-center, single-arm, Phase 1b/2 trial of onvansertib in combination with standard-of-care FOLFIRI and Avastin® (bevacizumab) to evaluate the safety and preliminary efficacy of the combination regimen in the second-line treatment of patients with KRAS-mutated mCRC. The trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second–Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation, is enrolling patients with histologically confirmed metastatic and unresectable colorectal carcinoma harboring a KRAS mutation. Patients must also have experienced disease progression or treatment intolerance to first-line treatment with fluoropyrimidine and oxaliplatin (FOLFOX or CapeOx) with or without bevacizumab to be eligible. The trial is being conducted at the following cancer centers across the U.S.: USC Norris Comprehensive Cancer Center, The Mayo Clinic (Arizona, Rochester, and Jacksonville), Kansas University Medical Center (KUMC), CARTI Cancer Center and Inova Schar Cancer Institute. For more information on the trial, please visit NCT03829410.
About the EAP for Onvansertib in KRAS-mutated mCRC
Sometimes called "compassionate use", expanded access is a potential pathway for a patient with a serious or life-threatening disease to gain access to an investigational drug for treatment outside of a clinical trial, particularly when no comparable or satisfactory alternative therapy options are available. The Cardiff Oncology EAP in KRAS-mutated mCRC is using the same combination treatment regimen (onvansertib 15 mg/m2 + FOLFIRI and bevacizumab) and dosing schedule as the ongoing Phase 1b/2 clinical trial and is intended for patients that have progressed on prior therapy and do not meet the second line eligibility criteria for enrollment in the clinical trial. The program has reached capacity and is no longer open to enrollment.
References:
- Giessen et al., Acta Oncologica 2015, 54: 187-193
- Cremolini et al., Lancet Oncol 2020, 21: 497–507
- Antoniotti et al., Correspondence Lancet Oncol June 2020
- Bennouna et al., Lancet Oncol 2013; 14: 29–37
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers. Our lead asset is onvansertib, a PLK1 inhibitor we are evaluating in combination with standard-of-care (SOC) therapeutics in clinical programs targeting indications such as KRAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, and metastatic castrate-resistant prostate cancer. These programs and our broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SOC. For more information, please visit https://www.cardiffoncology.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Cardiff Oncology Contact:
James Levine
Chief Financial Officer
858-952-7670
jlevine@cardiffoncology.com
Investor Contact:
Joyce Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com
Media Contact:
Amy Jobe, Ph.D.
LifeSci Communications
315-879-8192
ajobe@lifescicomms.com
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SOURCE Cardiff Oncology, Inc. | https://www.ktre.com/prnewswire/2022/09/10/cardiff-oncology-announces-new-preclinical-clinical-data-program-kras-mutated-metastatic-colorectal-cancer-mcrc-esmo-congress-2022/ | 2022-09-10T19:00:28 | en | 0.910282 |
BEIJING, Sept. 10, 2022 /PRNewswire/ -- The Mid-Autumn Festival, also known as the Moon Festival, is celebrated by millions of people on the 15th day of the eighth month of the Chinese lunar calendar. This year, the day falls on September 10.
The Mid-autumn festival is not just about family reunions. It's also about the joy of harvesting, romance and the harmony between humans and nature.
The Mid-Autumn Festival is a synthesis of seasonal customs in autumn, and most of the festival elements it contains have ancient origins. An essential part of the festival celebration is moon worship. In ancient agrarian societies, people believed that the moon's operation was closely related to agricultural production and seasonal changes, so the Moon Festival became a critical ritual activity.
Since ancient times, there have been many legends about the moon in China. For the Chinese, the moon is symbolized as being holy, pure and noble. Over tens of thousands of poems describing the moon have been recorded.
There are many interesting stories explaining the origin of the festival. The story of Chang'e and Hou Yi is the most widely accepted by Chinese people. Long ago there was a beautiful lady, Chang'e, whose husband was a brave archer, Hou Yi. But one day she drank a bottle of elixir that made her immortal to honor her husband's instructions to keep it safe. Then she was separated from her beloved husband, floating up into the sky, and finally landing on the moon, where she lives to this day.
In modern times the festival has evolved to the point where eating mooncakes has become a custom throughout China. Folk customs feature a series of festive activities such as moon viewing with families, guessing lantern riddles, carrying brightly lit lanterns, performing dragon and lion dances and more.
CMG's Mid-Autumn Festival Gala
Presented by China Media Group (CMG), the annual gala, also known as Qiuwan in Chinese, began at 8 p.m. Beijing Time on September 10 and lasted over two hours, presenting a creative and excellent extravaganza to audiences from all over the world.
The gala was divided into three chapters, started with Kunqu Opera and Pingtan (a regional musical/oral performance art). It presented a unique "Suzhou-style Mid-Autumn Festival" show with the cultural characteristics of waterfront towns south of the Yangtze River.
The gala featured an all-star cast. In Jiyang Lake Park at Zhangjiagang of Jiangsu Province, the main venue, Chinese stars including Li Yugang, Huang Ling and Na Ying staged various styles of songs. Among the many moon-themed songs were new renditions of traditional Chinese poetry of the great poets of the past.
Shenzhou-14 taikonauts Chen Dong, Liu Yang and Cai Xuzhe spent the first ever "Mid-Autumn Festival in Space" on China's space station. The three taikonauts recorded an exclusive video for the gala, sending their Mid-Autumn wishes and a "lucky star" to the Chinese people worldwide.
As an annual event that unites Chinese people worldwide, CMG's Mid-Autumn Festival Gala has attracted widespread attention from domestic and international media since its official announcement.
Over the Moon – CGTN's Mid-Autumn Festival Live Show
On the day of the festival, CGTN also brought the "Over the Moon – Mid Autumn Festival Live Show" to global audiences to showcase the vigor and charm of traditional Chinese culture from 4 p.m. to 10 p.m.
The Live Show strung together a series of featured programs including The Chat Room, VIBE's Mid-Autumn special edition, Mid-Autumn Night in Dunhuang, and CMG's Mid-Autumn Festival gala.
For thousands of years, the full moon and the reunion have been the consistent themes of the Mid-Autumn Festival, along with sipping tea, reciting poems, talking about different traditions in various countries, enjoy the "moon" and even interacting with "the jade rabbit" in the XR virtual scene and travel through ancient and modern times to celebrate the festival; the six-hour-long live show featured some of the best Mid-Autumn Festival programs and videos produced by CGTN and advanced audiovisual technology.
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SOURCE CGTN | https://www.ktre.com/prnewswire/2022/09/10/cgtn-2022-mid-autumn-festival-gala-family-feast-chinese-worldwide/ | 2022-09-10T19:00:35 | en | 0.955432 |
HOUSTON, Sept. 9, 2022 /PRNewswire/ -- CITGO Holding, Inc., a Delaware corporation (the "Company"), today announced the expiration and final results of its previously announced offer to purchase (the "Offer") for cash up to $286.231 million in aggregate principal amount (the "Excess Cash Flow Offer Amount") of its 9.25% Senior Secured Notes due 2024 (the "Notes") at a purchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the settlement date, on the terms and subject to the conditions set forth in the Offer to Purchase, dated August 11, 2022 (the "Offer to Purchase").
The Offer expired at 5:00 p.m., New York City time, on September 9, 2022 (the "Expiration Time"). As of the Expiration Time, $12.282 million in aggregate principal amount of the Notes had been validly tendered and not validly withdrawn prior to the Expiration Time.
Because the aggregate principal amount for all Notes tendered in the Offer did not exceed the Excess Cash Flow Offer Amount of $286.231 million, the Company will purchase $12.282 million aggregate principal amount of Notes pursuant to the Offer. Payment for such accepted Notes will be made on September 16, 2022. After giving effect to the purchase of the tendered and accepted Notes, approximately $1.358 billion in aggregate principal amount of the Notes will remain outstanding.
The Notes are governed by an indenture, dated as of August 1, 2019 (the "Indenture"), by and among the Company, the Guarantors party thereto and TMI Trust Company, as trustee (the "Trustee"). Under the terms of the Indenture, the Company is obligated to offer to purchase for cash an aggregate principal amount of up to the Excess Cash Flow Offer Amount of its outstanding Notes at the price described above. The Offer was made to satisfy this requirement.
The Excess Cash Flow Offer Amount is equal to 50% of the Excess Cash Flow (as defined in the Indenture) of the Company and certain of its subsidiaries for the Excess Cash Flow Period (as defined in the Indenture), minus the mandatory prepayment offer amount under the excess cash flow offer provisions of the Term Loan Facility (as defined in the Indenture). In this regard, the Company made a concurrent offer of prepayment equal to approximately $482.673 million in aggregate principal amount of outstanding indebtedness under the Term Loan Facility, of which $216 million was accepted. The Offer and the concurrent offer under the Term Loan Facility were not conditioned on one another.
This announcement is not an offer to purchase or sell, or a solicitation of an offer to purchase or sell any securities in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction.
About CITGO Holding, Inc.
CITGO Holding, Inc. ("CITGO Holding" or the "Company") is the direct parent of CITGO Petroleum Corporation ("CITGO"). CITGO Holding is a wholly-owned subsidiary of PDV Holding, Inc. ("PDV Holding"), a Delaware corporation and an indirect wholly-owned subsidiary of Petróleos de Venezuela, S.A. ("PDVSA" or "ultimate parent"), which is a Venezuelan corporation 100% owned and controlled by the Government of Venezuela.
CITGO manufactures or refines and markets transportation fuels as well as petrochemicals, other industrial products and lubricants. We own and operate three large-scale, highly complex petroleum refineries with a total rated crude oil refining capacity of approximately 769,000 barrels per day, located in Lake Charles, Louisiana, Corpus Christi, Texas and Lemont, Illinois. Our refining operations are supported by an extensive distribution network, which provides reliable access to our refined product end-markets. We own 35 active refined product terminals with a total storage capacity of 18.3 million barrels and have equity ownership of an additional 3.5 million barrels of refined product storage capacity through our joint ownership of an additional eight terminals, spread across 22 states. We own or have an equity interest in four additional terminals, consisting of approximately 1 million barrels of refined storage capacity, which are currently inactive or only utilized to store feedstocks used in refining operations. We also have access to more than 140 third-party terminals through exchange, terminaling and similar arrangements. Our retail network consists of approximately 4,300 independently owned and operated CITGO-branded retail outlets located east of the Rocky Mountains. We and our predecessors have had a recognized brand presence in the U.S. for over 100 years.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "will," "would," "should," the negative of these terms and similar terms and phrases. These statements relate to, among other things, expectations regarding revenues, costs and expenses, refining and other margins, profitability, cash flows, capital expenditures, liquidity and capital resources, our working capital requirements and other financial and operating items. These statements also relate to our industry, business strategy, goals and expectations concerning our market position and future operations. Any forward-looking statements are not guarantees of our future performance and are subject to risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these forward-looking statements. These statements are based on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Although we believe the assumptions upon which these forward-looking statements are based are reasonable, any of these assumptions could prove to be inaccurate, and the forward-looking statements based on these assumptions could be incorrect. In addition, our business and operations involve numerous risks and uncertainties, many of which are beyond our control, which could result in our expectations not being realized or could otherwise materially affect our financial condition, results of operations and cash flows. We caution to readers that these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the results that are projected, expressed or implied. We do not undertake any obligation to update any forward-looking statements, whether as a result of new information or development, future events or otherwise, except as required by law. Readers are cautioned not to place undue reliance on any of these forward-looking statements.
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SOURCE CITGO Corporation | https://www.ktre.com/prnewswire/2022/09/10/citgo-holding-inc-announces-expiration-final-results-offer-purchase-up-286231-million-aggregate-principal-amount-its-925-senior-secured-notes-due-2024/ | 2022-09-10T19:00:42 | en | 0.959723 |
NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- ClaimsFiler, a FREE shareholder information service, reminds investors that they have until October 25, 2022 to file lead plaintiff applications in a securities class action lawsuit against Coupang, Inc. (NYSE: CPNG), if they purchased or acquired the Company's shares pursuant and/or traceable to the Company's March 2021 initial public offering (the "IPO"). This action is pending in the United States District Court for the Southern District of New York.
Coupang investors should visit us at https://claimsfiler.com/cases/nyse-cpng/ or call toll-free (844) 367-9658. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
Coupang and certain of its executives are charged with failing to disclose material information in its IPO Registration Statement, violating federal securities laws.
The alleged false and misleading statements and omissions include, but are not limited to, that: (i) the Company was engaged in improper anti-competitive practices with its suppliers and other third parties in violation of applicable regulations; (ii) the Company had improperly adjusted search algorithms and manipulated product reviews on its marketplace platform in order to prioritize its own private-label branded products over those of other sellers and merchants, to the detriment of consumers, merchants, and suppliers; (iii) unbeknownst to its Rocket WOW members, Coupang was selling products to non-member customers at lower prices than those offered to its Rocket WOW members; (iv) the Company subjected its workforce to extreme, unsafe, and unhealthy working conditions; (v) all of the above illicit practices exposed the Company to a heightened, but undisclosed, risk of reputational and regulatory scrutiny that would harm the Company's critical relationships with consumers, merchants, suppliers, and the workforce; and (vi) the Company's lower prices, historical revenues, competitive advantages, and growing market share were the result of systemic, improper, unethical, and/or illegal practices, and, thus, unsustainable.
The case is Choi v. Coupang, Inc., No. 22-cv-07309.
ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. At ClaimsFiler.com, investors can: (1) register for free to gain access to information and settlement websites for various securities class action cases so they can timely submit their own claims; (2) upload their portfolio transactional data to be notified about relevant securities cases in which they may have a financial interest; and (3) submit inquiries to the Kahn Swick & Foti, LLC law firm for free case evaluations.
To learn more about ClaimsFiler, visit www.claimsfiler.com.
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SOURCE ClaimsFiler | https://www.ktre.com/prnewswire/2022/09/10/coupang-shareholder-alert-claimsfiler-reminds-investors-with-losses-excess-100000-lead-plaintiff-deadline-class-action-lawsuit-against-coupang-inc-cpng/ | 2022-09-10T19:00:49 | en | 0.940751 |
NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- ClaimsFiler, a FREE shareholder information service, reminds investors that they have until October 24, 2022 to file lead plaintiff applications in a securities class action lawsuit against Dingdong (Cayman) Limited (NYSE: DDL), if they purchased or acquired the Company's American Depository Shares ("ADS") pursuant and/or traceable to the Company's June 2021 initial public offering (the "IPO"). This action is pending in the United States District Court for the Southern District of New York.
Get Help
Dingdong investors should visit us at https://claimsfiler.com/cases/nyse-ddl/ or call toll-free (844) 367-9658. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
About the Lawsuit
Dingdong and certain of its executives are charged with failing to disclose material information in its IPO Registration Statement, violating federal securities laws.
The alleged false and misleading statements and omissions include, but are not limited to, that: (i) the Company was disregarding food safety responsibilities, failing to deliver on its stated commitment to provide "fresh" groceries to customers; (ii) the Company's quality control measures were inadequate, exposing it to an increased risk of regulatory and/or governmental scrutiny and enforcement; and (iii) as a result of the foregoing, the Company's Registration Statement was materially false and misleading at all relevant times.
The case is Mccormack v. Dingdong (Cayman) Ltd., et al, No. 22-cv-7273.
About ClaimsFiler
ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. At ClaimsFiler.com, investors can: (1) register for free to gain access to information and settlement websites for various securities class action cases so they can timely submit their own claims; (2) upload their portfolio transactional data to be notified about relevant securities cases in which they may have a financial interest; and (3) submit inquiries to the Kahn Swick & Foti, LLC law firm for free case evaluations.
To learn more about ClaimsFiler, visit www.claimsfiler.com.
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SOURCE ClaimsFiler | https://www.ktre.com/prnewswire/2022/09/10/dingdong-shareholder-alert-claimsfiler-reminds-investors-with-losses-excess-100000-lead-plaintiff-deadline-class-action-lawsuit-against-dingdong-cayman-limited-ddl/ | 2022-09-10T19:00:55 | en | 0.929795 |
The Exhibition, which celebrates Disney 100 Years of Wonder, launches a World Tour at Philadelphia's Franklin Institute on February 18, 2023, with next stops announced, including Chicago, IL, Kansas City, MO, and Munich, Germany
PHILADELPHIA, Sept. 10, 2022 /PRNewswire/ -- Today at D23 Expo: The Ultimate Disney Fan Event in Anaheim, CA, exciting new details and stops were announced for the upcoming world premiere of Disney100: The Exhibition. Created for the 100-year celebration of The Walt Disney Company, the exhibition will immerse guests in the beloved stories that have been dazzling guests since 1923, when Walt Disney set his company on a path that would revolutionize the entertainment industry. The world premiere of the exhibit opens on February 18, 2023, at The Franklin Institute in Philadelphia, PA, with Chicago, IL, and Kansas City, MO, set as the next two stops on the North American tour. The international unit of the exhibit will open on April 18, 2023, in Munich, Germany, with more cities to be announced in the coming months.
The official exhibition poster and trailer were also revealed today.
Disney100: The Exhibition Poster
Disney100: The Exhibition Trailer
"As we prepare to kick off Disney 100 Years of Wonder, we are incredibly excited to bring this fantastic exhibition to life," said Becky Cline, director, Walt Disney Archives. "We can't wait for guests to experience their favorite Disney stories, characters, and attractions in new and immersive ways as we celebrate all the wonderful worlds of Disney."
President and CEO of The Franklin Institute Larry Dubinski added, "The Franklin Institute is thrilled to host Disney100: The Exhibition, the first major event to mark the global celebration of Disney's 100 years, allowing fans throughout the Philadelphia region and beyond the very first opportunity to see these crown jewels come to life in beautifully crafted galleries reflecting the creative empire synonymous with imaginative storytelling, innovation, discovery, and wonder."
Over the past 100 years, Disney has brought its iconic stories and characters to life in new and innovative ways, becoming part of the global culture and creating generations of memories for billions. Disney100: The Exhibition invites guests to step into their favorite stories using innovation and immersive technology throughout ten galleries in the 15,000-square-foot exhibit.
The Walt Disney Archives opens its vault of treasures, showcasing hundreds of extraordinary objects, including many of Disney's "Crown Jewels" - more than 250 rarely seen original artworks and artifacts, costumes and props, and other memorabilia. Disney has curated special behind-the-scenes glimpses into the creation of the most popular characters, films, shows, and attractions – from Disneyland to Walt Disney World® Resort and beyond. The ten magnificent and imaginatively themed galleries, with moving stories, unique interactive installations, and exciting background information, will take visitors on a journey through 100 years of The Walt Disney Company, celebrating the classics from Snow White and the Seven Dwarfs to Strange World, as well as the latest members of the Disney family – Pixar, Star Wars, Marvel, and National Geographic.
Disney100: The Exhibition Facts:
-Ten large, themed galleries with numerous cutting-edge interactive installations covering 15,000 square feet
-February 18, 2023: World Premiere at The Franklin Institute in Philadelphia, launching the U.S. tour
-April 18, 2023: European Premiere in Munich
-Created and curated by the Walt Disney Archives and Semmel Exhibitions
The Franklin Institute is proud to present and play host to the world premiere of Disney100: The Exhibition in the Nicholas and Athena Karabots Pavilion and the Mandell Center. PECO, the premier corporate partner of The Franklin Institute, is the Local Presenting Sponsor of the exhibition.
About The Franklin Institute
Located in the heart of Philadelphia, The Franklin Institute is a renowned and innovative leader in science and technology learning and a dynamic center of activity. As Pennsylvania's most visited museum, it is dedicated to creating a passion for learning about science by offering access to hands-on science education. For more information, visit www.fi.edu.
About the Walt Disney Archives
For more than 50 years, the Walt Disney Archives has carefully safeguarded the most treasured items from The Walt Disney Company's history, including original scripts, movie props and costumes, Walt Disney's correspondence and script notes, theme park artifacts, merchandise, millions of archival photographs, and many of Walt's personal effects. Founded by Disney Legend Dave Smith in 1970, the Walt Disney Archives is a vital resource for every part of Disney, as well as an important research center for Disney scholars, researchers, and writers. The Archives also shares its countless pieces with Disney fans everywhere through its exhibitions and close association with D23: The Official Disney Fan Club.
For the Walt Disney Archives:
Jeffrey R. Epstein
The Walt Disney Company
Jeffrey.R.Epstein@Disney.com
About Semmel Exhibitions
Semmel Exhibitions creates exhibitions, which travel worldwide, and hosts international exhibitions in Germany, Austria, and German-speaking Switzerland. Semmel Exhibitions is a division of Semmel Concerts Entertainment, the large German live entertainment producer. Since Semmel Exhibitions started touring its exhibitions TUTANKHAMUN – HIS TOMB AND HIS TREASURES; THE DISCOVERY OF KING TUT; and most recently MARVEL: UNIVERSE OF SUPER HEROES and SPIDER-MAN: BEYOND AMAZING – THE EXHIBITION, they have reached an audience of more than seven million people worldwide, and built a strong international network within museums, science centers, cultural venues and the creative industries. More information at semmel-exhibitions.com.
Media Contact:
Stefanie Santo
The Franklin Institute
ssanto@fi.edu 215.448.1152
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SOURCE The Franklin Institute | https://www.ktre.com/prnewswire/2022/09/10/disney100-exhibition-immerse-guests-worldwide-magic-disney/ | 2022-09-10T19:01:02 | en | 0.923557 |
Multicultural OBGYN advocates amplifying stories to keep reproductive justice in the forefront
PORTLAND, Ore., Sept. 10, 2022 /PRNewswire/ -- It's been almost three months since Roe v. Wade has been overturned. While many in states with restrictive abortion are adjusting to their "new normal," multicultural OBGYNs Drs. Jenn Conti, Heather Irobunda and Jennifer Lincoln are just getting started, and they're not giving up the fight.
Today, they announce the launch of their organization Obstetricians for Reproductive Justice (ORJ), an organization that works to share the stories of the real-time harm happening to patients and providers in post-Roe America. ORJ will travel to communities where their presence is needed to bring financial and logistical support as well as education, and by amplifying stories in traditional and social media keeping reproductive justice in the forefront. ORJ's pilot trip is taking place this weekend in San Antonio and Austin, Texas, a location with some of the most restrictive abortion laws in the country.
Drs. Conti, Irobunda and Lincoln are nimble, bold, and in positions of power as reproductive health experts in protected states – and they are ready to act.
"We're hearing from our colleagues and from people all over the country who have been harmed by the assault on our reproductive freedoms. We're now entering the fight – because who else better to do it than a group of pissed off OBGYNs?" says Drs. Conti, Irobunda and Lincoln.
ORJ has three goals:
- To amplify (with permission) stories of patients who have been harmed by these changes, with a focus on communities that are most vulnerable
- To educate the general public on the actual harm occurring by sharing stories as they happen in real-time, and
- To advocate for the provision of direct services and funding to communities that are most vulnerable in a post-Roe world.
Drs. Jenn Conti, Heather Irobunda and Jennifer Lincoln are trusted OBGYNs active in advocacy with a combined 3.5 million followers on social media, and a track record of going viral and making change happen. Dr. Conti, of Stanford, Calif, is a complex family planning physician, author and medical journalist; Dr. Irobunda is a Bronx, NY-based OBGYN medical advisor and writer; and Dr. Lincoln, from Portland, Ore., is a OB Hospitalist, author, and founder of ThreeForFreedom.com, a hub for education on simple steps folks can take to control their reproductive freedom.
To join the fight and learn more, visit https://obstetriciansforreprojustice.org and follow them on Twitter: @OBs4RJ.
Media contact:
Shelby Janner
Zilker Media
shelby@zilkermedia.com
512.298.4081 x702
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SOURCE Obstetricians for Reproductive Justice | https://www.ktre.com/prnewswire/2022/09/10/drs-jenn-conti-heather-irobunda-jennifer-lincoln-launch-obstetricians-reproductive-justice-share-stories-harm-happening-post-roe-america/ | 2022-09-10T19:01:09 | en | 0.952731 |
Analysis Evaluates Efficacy of Eribulin in Metastatic HER2-low Breast Cancer Across Three Studies (Presentation: #259P)
NUTLEY, N.J., Sept. 10, 2022 /PRNewswire/ -- Eisai announced today results from a post-hoc analysis of three randomized, pivotal, Phase 3 studies (EMBRACE trial/Study 305, Study 301, and Study 304) evaluating the efficacy of eribulin mesylate (marketed as HALAVEN®) versus other chemotherapies (Treatment of Physician's Choice [TPC], capecitabine, and vinorelbine, respectively) in patients living with metastatic breast cancer (mBC) whose tumors have low or no HER2 expression. These data were presented as a poster (Presentation: #259P) at the European Society for Medical Oncology (ESMO) Annual Meeting (#ESMO22), held virtually and in-person in Paris, France from September 9-13, 2022.
The HER2-low breast cancer subtype is a newly defined subset consisting of tumors that would have previously been considered HER2-negative based on an immunohistochemistry (IHC) assay and an in situ hybridization (ISH) assay. HER2-low tumors express low amounts of the HER2 protein, but not enough to be considered HER2-positive. HER2-low is defined as an IHC of 1+ or 2 with a negative ISH. Of the approximate 288,000 new cases of female breast cancer expected to be diagnosed in the U.S. in 2022, it is estimated that approximately 80-85% of patients would previously have been considered to have the HER2-negative subtype. Of those patients, about 60% would now be considered to have the HER2-low subtype.
"In this post-hoc analysis, the outcomes seen in mBC patients whose tumors are considered HER2-low are consistent with the results of the three pivotal Phase 3 clinical trials," said Dr. Takashi Owa, Chief Scientific Officer, Senior Vice President, Eisai Co., Ltd. "As the oncology community's understanding of mBC continues to evolve, it's important that we continue to evaluate the role of existing therapies in new contexts to contribute to the body of knowledge that is available to health care professionals."
The post-hoc analysis included data from three trials— eribulin vs. TPC (NCT00388726, EMBRACE trial/Study 305), eribulin vs. capecitabine (NCT00337103, Study 301), and eribulin vs. vinorelbine (NCT02225470, Study 304) in patients with locally recurrent or mBC who had prior lines of chemotherapy treatments (≤2 for Study 301; 2-5 for Study 304 and EMBRACE Trial/Study 305) including an anthracycline and a taxane. A total of 1,589 eligible patients were enrolled in the EMBRACE trial/Study 305, Study 301, and Study 304, and baseline characteristics were generally balanced between treatment arms in all studies.
Median overall survival (OS), median progression free survival (PFS) and objective response rate (ORR) were analyzed. PFS and ORR were measured per Response Evaluation Criteria in Solid Tumors Version (RECIST) (v1.0 for EMBRACE trial/Study 305 and Study 301; v1.1 for Study 304) by independent imaging review. ORR was measured in evaluable patients (EMBRACE trial/Study 305) and in the intent-to-treat population (Study 301 and Study 304).
In the post-hoc analysis, OS, PFS, and ORR among patients with HER2-low or HER2-negative status were generally similar to those of the eribulin treatment arms overall in each of the EMBRACE trial/Study 305, Study 301 and Study 304. Efficacy results for patients with HER2-low and HER2-negative status across all three studies are summarized in the table below:
Metastatic breast cancer (mBC) is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body. It is estimated there were more than 2,261,000 new cases of breast cancer and more than 684,000 deaths from the disease globally in 2020. In 2022, it is estimated that approximately 288,000 women will be diagnosed with breast cancer in the United States and over 43,000 women will die from the disease. It is estimated that 30% of people with early-stage breast cancers will go on to develop metastatic disease, and approximately 6% of women with breast cancer will have metastatic disease at the time of diagnosis. Metastatic breast cancer has a poor prognosis compared to non-metastatic breast cancer. The estimated 5-year relative survival rate for women with mBC is 28%.
HALAVEN (eribulin mesylate) Injection is indicated for the treatment of patients with metastatic breast cancer (mBC) who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Eribulin is a microtubule dynamics inhibitor in the halichondrin class with a novel mechanism of action, developed in-house by Eisai. Structurally, eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. In addition, non-clinical studies showed eribulin's unique actions in the tumor microenvironment such as an increase in vascular perfusion and permeability in tumor cores, promotion of the epithelial state, decrease in capacity of breast cancer cells to migrate, etc.
Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.
Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.
Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.
QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).
Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.
Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.
For more information about HALAVEN, click here for the full Prescribing Information.
HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept [also known as our human health care (hhc) Concept], we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia, and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on Twitter (U.S. and global) and LinkedIn (for U.S. and EMEA).
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SOURCE Eisai Inc. | https://www.ktre.com/prnewswire/2022/09/10/eisai-presents-results-post-hoc-analysis-eribulin-mesylate-halaven-european-society-medical-oncology-esmo-congress-2022/ | 2022-09-10T19:01:15 | en | 0.919932 |
NEWPORT BEACH, Calif., Sept. 9, 2022 /PRNewswire/ -- The environmental law attorneys at Manning Law, APC proudly announce a settlement on behalf of Calsafe Research Center, Inc., a California non-profit corporation dedicated to keeping Californians safe from exposure to products that are alleged to contain chemicals known to cause cancer or reproductive harm in violation of Proposition 65.
Proposition 65, "The Safe Drinking Water and Toxic Enforcement Act of 1986" is a "right to know" law intended to protect Californians. Through its required warnings, Proposition 65 alerts consumers in the State of California to the risk of potential exposures to substances causing cancer or reproductive harm and provides them with the ability to make an informed decision regarding whether to purchase, consume or use such products. Calsafe Research Center, Inc. acts in the public interest as a private enforcer of Proposition 65 through civil law enforcement actions initiated by its counsel, Manning Law, APC.
Material details of settlement:
"Since California residents overwhelmingly voted to enact Proposition 65 in 1986 the act has generated substantial reductions in the content of toxic chemicals in consumer touching products. Where products inherently include a Proposition 65 listed chemical that cannot be removed, warning labels have empowered Californians to make an informed decision about being exposed to the product," said Manning Law, APC co-founder Michael J. Manning.
Babak (Bobby) Hashemi, who also represents Calsafe Research Center, Inc. in advancing the public's interest through environmental litigation, said "I am proud to represent an organization dedicated to protecting the health and autonomy of California residents."
Manning Law, APC is known for its civil rights, consumer, and environmental protection litigation including its precedent setting litigation under the Americans with Disabilities Act ("ADA") and the Unruh Civil Rights Act ("UCRA"). In particular, the firm is known for its role as plaintiff's counsel in the first federal appellate case to recognize the application of the ADA and UCRA to websites and mobile applications, see Robles v. Domino's Pizza, LLC, No. 17-55504 (9th Cir. 2019). Manning Law, APC has also been recognized by the Office of the Secretary of Defense of the United States as a "Patriotic Employer" for its support of employee participation in the National Guard and Reserve Force.
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SOURCE Manning Law APC | https://www.ktre.com/prnewswire/2022/09/10/environmental-law-attorneys-manning-law-apc-continue-streak-settlements-prevent-public-exposure-lead/ | 2022-09-10T19:01:22 | en | 0.948163 |
Multi-Biomarker Approach Achieves 61 Percent Sensitivity for Cancer at an Overall Specificity of 98.2 Percent in Robust Case-Control Study Including Nearly 600 Cancer Samples
Data will Inform the Largest Registrational Multi-Cancer Early Detection Study Ever Conducted in the United States to Support Another Leading Test in Exact Sciences' Screening Portfolio
MADISON, Wis., Sept. 10, 2022 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced data from a multi-cancer early detection (MCED) biomarker validation study was presented at the European Society for Medical Oncology (ESMO) Congress. The study rigorously assessed the performance of four distinct biomarker classes found in the blood and known to signal the presence of cancer regardless of its location in the body.
"Cancer releases a diverse set of biomarkers into the blood that can be harnessed to detect the devastating disease at earlier stages," said Tom Beer, M.D., F.A.C.P., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. "These data demonstrate in a large, well-designed case-control study that combining different cancer biomarkers improves cancer detection, especially in stages I and II, when treatment may be more effective for patients. This is a major step forward in our mission to detect cancer earlier before signs and symptoms appear."
Four biomarker classes, discovered through years of collaboration with Johns Hopkins and Mayo Clinic and analyzed together for the first time in this study, demonstrated the ability to detect cancer signal from 15 organ sites with a mean sensitivity of 61% and mean specificity of 98.2%. The multi-biomarker approach, including aneuploidy, proteins, and DNA methylation and mutations, provided encouraging cancer detection in stages I and II, with a combined sensitivity of 38.7%.
Sensitivities by Cancer Stage for Four-Biomarker Class Set
The retrospective, case-control study included cancers from 11 organ sites with no recommended screening option today and 15 organ sites and tissue in total, including breast, bladder, colon, esophageal, kidney, liver, lung, multiple myeloma, myelodysplastic syndrome, non-Hodgkin's lymphoma, ovarian, pancreatic, prostate, stomach, and uterine. The non-cancer control cohort included age-matched, presumably healthy individuals and samples from individuals with non-cancer diseases to represent the intended use population more effectively.
Many cancers can be cured if detected early and treated effectively.i Yet cancer remains the second leading cause of death worldwide, accounting for approximately 1 in every 6 deathsii, with no recommended screening tests available for 70 percent of cancer diagnoses.
"Being able to screen patients for multiple cancers with a blood test, especially those that don't have a current screening option, is extremely exciting," said Anne Marie Lennon M.B.B.Ch., Ph.D. Director, Division of Gastroenterology and Hepatology and Professor of Medicine at Johns Hopkins Medicine. "Robust studies like this one are important in understanding the potential effectiveness of a multi-biomarker approach to MCED. This study shows encouraging signs that cancers, including early-stage cancers, can be detected, providing us the opportunity to improve patient outcomes by treating the disease when it is typically most responsive to therapy."
The study presented at ESMO builds on the insights and experience gained from earlier versions of the MCED test used in the DETECT-A study. DETECT-A, the first and only prospective, interventional study of 10,000 women to screen for multiple cancers, demonstrated the ability of an MCED test to more than double the number of screening-detected cancers compared to standard-of-care screening methods alone.iii
A larger case-control study is underway to further validate the results shared at ESMO and determine the final design of the MCED test. Exact Sciences will then begin recruiting patients for the FDA registrational Study Of All comeRs (SOAR) trial in MCED during 2023. The SOAR trial will be the largest prospective, interventional MCED trial ever conducted in the United States. Exact Sciences plans to leverage its leading presence in primary care and cancer screening to accelerate the availability of MCED and deliver this powerful innovation to patients in need.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype tests, Exact Sciences is investing in its product pipeline to support patients before and throughout their cancer diagnosis and treatment. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.
Forward-Looking Statements
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. There can be no assurance as that future studies will successfully validate the data from the retrospective, case-control study discussed in this news release or that Exact Sciences will be able to successfully develop or market any multi-cancer early detection tests. Therefore, you should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of Exact Sciences' most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in Exact Sciences' other reports filed with the Securities and Exchange Commission. Exact Sciences undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Media Contact:
608-852-9877
Media (Canada, Europe, Asia, Latin America):
Federico Maiardi
+41 79-138-1326
Investors:
Megan Jones
+1 608-535-8815
i World Health Organization; February 2022 https://www.who.int/news-room/fact-sheets/detail/cancer
ii American Cancer Society, Global Facts and Figures 2022 https://www.cancer.org/research/cancer-facts-statistics/global.html
iii Science, April 2020 Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention
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SOURCE EXACT SCIENCES CORP | https://www.ktre.com/prnewswire/2022/09/10/exact-sciences-demonstrates-power-multi-cancer-early-detection-approach-with-data-presentation-2022-european-society-medical-oncology-congress/ | 2022-09-10T19:01:29 | en | 0.911018 |
- The exclusive event held in Havana, Cuba, was attended by people from 43 countries and renowned national and international artists, such as James Morrison, who was in charge of giving the closing concert of the evening
- During the event, two unique humidors in the world were auctioned for which 2,900,000€ were raised, funds that will go entirely to Cuban Public Health
HAVANA, Sept. 10, 2022 /PRNewswire/ -- The long-awaited celebration of the 55th anniversary of Cohiba, Habanos' most emblematic and prestigious brand, took place in Havana, Cuba, the birthplace of what is considered the best cigar in the world. For three days, Habanos, S.A. offered its guests a full program of activities starting with a Welcome Cocktail, followed by a visit to the El Laguito Factory and ended with the acclaimed Gala Dinner.
Two years after the last Habano Festival, Cuba was once again visited by aficionados of Premium cigars, especially Habanos, with a Welcome Cocktail for 650 lucky people. Attendees were treated to a magical evening with an experiential journey through the brand's more than five decades of successful history and its main Lines: Classic, 1492, Maduro 5 and Behike.
There was also a visit to the emblematic El Laguito Factory, where the Cohiba brand vitolas have been produced since 1966, ensuring the delicacy and quality of these Habanos.
The final touch was provided by the exclusive Gala Dinner with 650 attendees from 43 countries and focused on the novelties that Habanos, S.A. presented on the so-called "Cohiba Year" with its launches Cohiba Ambar, Cohiba Colección Ideales and Cohiba 55 Aniversario Edición Limitada.
This dinner was the culmination of all the celebrations held around the world to commemorate Cohiba's 55th anniversary. An event full of tradition, luxury and moments of pleasure with the Habano as the protagonist, which has received international recognition from the most demanding aficionados. Since its birth in 1966, Cohiba has been synonymous with exclusivity, tradition and quality. The gala was attended by renowned artists with long careers such as César López, Miguel Patterson and Manolito Simonet, as well as by leading figures from the music scene such as Niurka González, Haila, Lily Daly and Mayko D'Alma, and artists with innovative proposals such as Camila Rodhe, Geidy Chapman, Emilio Frías "El Niño," Vocal Renacer or Tenores Los Clásicos. The evening ended with a concert by the internationally renowned James Morrison.
According to Leopoldo Cintra González, Commercial Vice President of Habanos, S.A.: "In addition to luxury and exclusivity, Cohiba is synonymous with the work and effort of generations that have managed to make it the most recognized Habanos brand worldwide." He added: "How could it be otherwise, such a singular date deserved some launches at the height of what we call the "Cohiba Year" with three unique and special vitolas such as Cohiba Ámbar, Cohiba Ideales, and Cohiba 55 Aniversario Edición Limitada."
During the event, and for the first time outside the framework of the Habano Festival, the auction of two unique humidors was held. All the Habanos they contain were made " Totally by hand with long filler" and by the best torcedores of the El Laguito Factory. The proceeds will go entirely to Cuban Public Health.
The Cohiba 55th Anniversary Humidor, worth 2,800,000€, contains 550 Habanos from all the prestigious brand lines and represents a tribute to Cohiba's success story. Made with precious woods, mother-of-pearl, and Swarovski on the outside and okume and mahogany on the inside.
Humidor Rare Le Rituel & Cohiba Ambar, worth 100,000€, was made to include a bottle of Champagne Rare Milésime 1988 and 44 Cohiba Ambar. It is the first of a series of 10 Limited Edition Humidors handcrafted on demand by the prestigious artisan workshop Elie Bleu, which has been making humidors for tobacco since 1976.
The 2020 and 2021 Habanos Awards were also presented to Eulalio Bejarano and Riad Boukaram in the Business category, Walid Saleh and Angel Garcia Muñoz in the Communications category, and Vicente Fausto Torres and Nelson Rodriguez Lopez in the Production category.
Learn more about Cohiba's history here
To download high resolution images click here.
For more information about Habanos, S.A.:
www.habanos.com
https://www.instagram.com/habanos_oficial/
https://twitter.com/Habanos_Oficial
https://www.youtube.com/channel/UCstGLy96wdZG7eCM4855_DA
https://www.linkedin.com/company/habanos-sa/
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SOURCE Habanos S.A | https://www.ktre.com/prnewswire/2022/09/10/habanos-sa-celebrated-55-years-success-cohiba-worlds-most-prestigious-premium-tobacco-brand/ | 2022-09-10T19:01:35 | en | 0.940268 |
- Lemzoparlimab combined with AZA showed encouraging clinical response in higher-risk MDS patients
- For patients received initial dose over 3 months, the ORR is 80.6% and for patients received initial dose over 6 months the ORR is 86.7%, CR rate 40%
- Lemzoparlimab does not require priming dosing with no unexpected safety signals in combination therapy with AZA
- For subjects achieving CR, remaining gene mutation frequency such as TP53, TET2 and RUNX1 were significantly decreased
- A randomized Phase 3 trial in higher-risk MDS is planned
GAITHERSBURG, Md. and SHANGHAI, Sept. 10, 2022 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announces encouraging data from its Phase 2 clinical trial (NCT04202003) of lemzoparlimab (also known as TJC4) in combination with azacitidine (AZA) in patients with newly diagnosed higher risk myelodysplastic syndrome (HR-MDS), presented in an oral presentation on September 10 at the European Society for Medical Oncology (ESMO) Congress 2022.
The open-labeled Phase 2 clinical trial is designed to investigate the efficacy and safety of lemzoparlimab in combination with AZA in patients with newly diagnosed HR-MDS. A total of 53 patients were enrolled as of March 31, 2022, receiving lemzoparlimab at a weekly dose of 30 mg/kg intravenously (IV) and AZA at 75 mg/m2 subcutaneously (SC) on Days 1–7 in a 28-day cycle.
Top-line data showed that for patients who began treatments 6 months or longer prior to the analysis (n=15), the overall response rate (ORR) and complete response rate (CRR) was 86.7% and 40% respectively. For patients who began treatment 4 months or longer prior to the analysis (n=29), the ORR and CRR was 86.2% and 31% respectively. While the study enrolled more patients with worse baseline conditions due to underlying disease (74% of patients had grade ≥3 anemia and 51% of patients had grade ≥3 thrombocytopenia), the results showed that lemzoparlimab combined with AZA was well-tolerated and the safety profile was consistent with AZA monotherapy.
Decreased red blood cells, measured as hemoglobin, and decreased platelets are major causes of morbidity for patients with HR-MDS and the median hemoglobin and platelet levels for patients on study increased in response to treatment. Of the 29 patients who were dependent upon blood transfusions at baseline, 9 patients (31%) became transfusion independent at the time of analysis. Furthermore, the majority of CR patients showed reduction in variant allele frequency (VAF) of MDS-related gene mutation including TP53, TET2 and RUNX1, with 56% achieving minimal residual disease negativity (≤10-4) by flow cytometry. These data are consistent with the anti-leukemic activities and expected drug safety of lemzoparlimab.
"Without the need of priming dose, the latest Phase 2 data show clinically meaningful efficacy of lemzoparlimab treatment in combination with AZA among patients with newly diagnosed HR-MDS," said Prof. Zhijian Xiao, Professor at Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences, and leading principal investigator of the study. "The results are encouraging and provide further clinical validation to the promise of lemzoparlimab as a potential best-in-class CD47 antibody, especially for patients with HR-MDS or who are unfit for intensive therapy."
"The clinical activity seen with lemzoparlimab in combination with AZA thus far, in addition to the favorable safety profile, continues to show promise in this difficult-to-treat patient population," said Prof. Chunkang Chang, Director of Hematology Department of Shanghai Sixth People's Hospital, and leading principal investigator of the study. "Lemzoparlimab represents a potentially important novel treatment option for patients with HR-MDS as well as many other hematological malignancies. We're very enthusiastic about the results to date and look forward to advancing the trial and broadening its application into other malignancies."
"We are excited about the topline data of lemzoparlimab in HR-MDS selected for proffered oral presentation at ESMO Congress 2022," said Dr. Andrew Zhu, President of I-Mab. "The Phase 2 clinical data demonstrated a good safety profile, along with promising efficacy, and underscored I-Mab's commitment to bring transformational therapies to patients in need. These results warrant our focused efforts to advance lemzoparlimab towards initiation of a Phase 3 registrational trial."
The Company is on track to initiate a Phase 3 clinical trial in patients with MDS in China.
About CD47 and Lemzoparlimab
CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don't eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy has been hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.
Multiple clinical studies of lemzoparlimab are ongoing to explore indications in treating patients with myelodysplastic syndrome (MDS), acute myelocytic leukemia (AML), non-Hodgkin's lymphoma (NHL), and advanced solid tumors in combination with chemotherapy and immune checkpoint inhibitors.
About I-Mab
I-Mab (Nasdaq: IMAB) is a dynamic, global biotech company exclusively focused on discovery, development and soon, commercialization of novel or highly differentiated biologics in the therapeutic areas of immuno-oncology and autoimmune diseases. The Company's mission is to bring transformational medicines to patients around the world through innovation. I-Mab's innovative pipeline of more than 10 clinical and pre-clinical stage drug candidates is driven by the Company's Fast-to-Proof-of-Concept and Fast-to-Market development strategies through internal R&D and global partnerships and commercial partnerships. I-Mab has established its global footprint in Shanghai (headquarters), Beijing, Hangzhou, Guangzhou, Lishui and Hong Kong in China, and Maryland and San Diego in the United States. For more information, please visit http://www.i-mabbiopharma.com and follow I-Mab on LinkedIn, Twitter, and WeChat.
I-Mab Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the lemzoparlimab clinical studies, the potential implications of clinical data for patients, and I-Mab's advancement of, and anticipated clinical development, regulatory milestones, and commercialization of lemzoparlimab. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to I-Mab's ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or NDA/BLA approval; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of I-Mab's drug candidates; I-Mab's ability to achieve commercial success for its drug candidates, if approved; I-Mab's ability to obtain and maintain protection of intellectual property for its technology and drugs; I-Mab's reliance on third parties to conduct drug development, manufacturing and other services; I-Mab's limited operating history and I-Mab's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; and the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the "Risk Factors" section in I-Mab's most recent annual report on Form 20-F, as well as discussions of potential risks, uncertainties, and other important factors in I-Mab's subsequent filings with the US Securities and Exchange Commission. All forward-looking statements are based on information currently available to I-Mab, and I-Mab undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
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NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC ("KSF"), announces that KSF has commenced an investigation into International Business Machines Corporation ("IBM") (NYSE: IBM).
On October 20, 2021, the Company announced its financial results for the third quarter of 2021, disclosing total revenues for the quarter of $17.62 billion, a shortfall of $191.84 million based on analyst estimates, due largely to its Cloud & Cognitive Software segment, which had revenues of $5.69 billion - a shortfall of approximately $80 million based on analyst estimates of $5.77 billion.
Thereafter, the Company and certain of its executives were sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period, violating federal securities laws.
KSF's investigation is focusing on whether IBM's officers and/or directors breached their fiduciary duties to its shareholders or otherwise violated state or federal laws.
If you have information that would assist KSF in its investigation, or have been a long-term holder of IBM shares and would like to discuss your legal rights, you may, without obligation or cost to you, call toll-free at 1-877-515-1850 or email KSF Managing Partner Lewis Kahn (lewis.kahn@ksfcounsel.com), or visit https://www.ksfcounsel.com/cases/nyse-ibm/ to learn more.
KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation's premier boutique securities litigation law firms. KSF serves a variety of clients – including public institutional investors, hedge funds, money managers and retail investors – in seeking recoveries for investment losses emanating from corporate fraud or malfeasance by publicly traded companies. KSF has offices in New York, California, Louisiana and New Jersey.
To learn more about KSF, you may visit www.ksfcounsel.com.
Kahn Swick & Foti, LLC
Lewis Kahn, Managing Partner
lewis.kahn@ksfcounsel.com
1-877-515-1850
1100 Poydras St., Suite 3200
New Orleans, LA 70163
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AKRON, Ohio, Sept. 10, 2022 /PRNewswire/ -- In recognition of Breast Cancer Awareness month, KAY Jewelers® is proud to support Breast Cancer Alliance (BCA), by donating $20 for each piece of jewelry sold from their limited-edition Pink Lab-Created Opal styles during the month of October. These new styles, which are launching in September, and are created solely to support Breast Cancer efforts, will include a beautiful necklace, ring and earrings all featuring a Pink Lab-Created Opal with 10K Rose Gold.
"KAY is proud to be partnering with Breast Cancer Alliance once again. This impressive charity not only does research and community outreach, but they also provide important surgical fellowships that change lives. Having personally been impacted by this, it gives me great pride to have KAY assist them in this important fight," said Stephanie Lawler, VP of Merchandising for KAY Jewelers, Zales and Peoples.
Since its founding in 1996, Breast Cancer Alliance has committed to improving survival rates and quality of life for those impacted by breast cancer through better prevention, early detection, treatment, and cure. In that pursuit, BCA has become one of the most prominent breast cancer foundations in the US.
"We are honored to be partnering with KAY Jewelers again this year and are so appreciative of their continued support. It is partnerships like these that enable Breast Cancer Alliance to further its impact, funding critical, innovative, and life-saving grants which save lives and improve outcomes in breast cancer," noted Yonni Wattenmaker, BCA Executive Director.
These specially curated Pink Lab-Created Opal styles are available through October 31 while supplies last on Kay.com as well as in KAY stores nationwide. Each piece retails for $249.99. For more information, please visit www.Kay.com.
Breast Cancer Alliance is one of the largest private non-corporate breast cancer organizations in the U.S. Breast Cancer Alliance has awarded over $32 million in grants supporting its mission to improve survival rates and quality of life for those impacted by breast cancer through better prevention, early detection, treatment, and cure. To promote these goals, the organization invests in innovative research, breast surgery fellowships, regional education, dignified support and screening for the uninsured and underserved.
For information about BCA visit: https://breastcanceralliance.org
For over 100 years, KAY Jewelers has helped millions of people express love and celebrate life's most meaningful moments. Operated by Signet Jewelers Ltd., KAY Jewelers is America's #1 jewelry retailer and the world's largest retailer of diamond jewelry. For additional information on KAY Jewelers visit www.Kay.com.
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NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- ClaimsFiler, a FREE shareholder information service, reminds investors that they have until November 1, 2022 to file lead plaintiff applications in a securities class action lawsuit against Kohl's Corporation (NYSE: KSS), if they purchased the Company's securities between October 20, 2020 and May 19, 2022, inclusive (the "Class Period"). This action is pending in the United States District Court for the Eastern District of Wisconsin.
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Kohl's investors should visit us at https://claimsfiler.com/cases/nyse-kss-1/ or call toll-free (844) 367-9658. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
About the Lawsuit
Kohl's and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
On May 19, 2022, the Company disclosed disappointing 1Q2022 fiscal results including net sales growth and earnings per share below analyst expectations, as well as a cut to its full year earnings forecast, due to "macro headwinds related to lapping last year's stimulus and an inflationary consumer environment." Then, on May 20, 2022, Macellum Advisors GP, LLC, "a long-term holder of nearly 5% of the outstanding common shares of Kohl's," issued a statement addressing "[t]his quarter's extremely disappointing results," which it attributed to a "flawed strategic plan and an inability to execute," and that "the current Board appears to have withheld material information from shareholders about the state of Kohl's in the lead-up to this year's pivotal annual meeting," which "suggests to us a clear breach of fiduciary duty."
On this news, shares of Kohl's declined $5.84 per share, or 12.97%, to close at $39.20 per share on May 20, 2022.
The case is Shanaphy v. Kohl's Corporation, et al., No. 22-cv-01016.
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ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. At ClaimsFiler.com, investors can: (1) register for free to gain access to information and settlement websites for various securities class action cases so they can timely submit their own claims; (2) upload their portfolio transactional data to be notified about relevant securities cases in which they may have a financial interest; and (3) submit inquiries to the Kahn Swick & Foti, LLC law firm for free case evaluations.
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NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- ClaimsFiler, a FREE shareholder information service, reminds investors that they have until October 11, 2022 to file lead plaintiff applications in a securities class action lawsuit against LifeStance Health Group, Inc. (NasdaqGS: LFST), if they purchased or acquired the Company's Class A common stock pursuant and/or traceable to the Company's June 2021 initial public offering (the "IPO"). This action is pending in the United States District Court for the Southern District of New York.
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LifeStance investors should visit us at https://claimsfiler.com/cases/nasdaq-lfst/ or call toll-free (844) 367-9658. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
About the Lawsuit
LifeStance and certain of its executives are charged with failing to disclose material information in its IPO Registration Statement, violating federal securities laws.
The alleged false and misleading statements and omissions include, but are not limited to, that: (i) the Company's out-patient/virtual revenue growth was negatively affected by a decrease in virtual visits after COVID-19 lockdowns were lifted; (ii) an increasing number of in-person visits post-lockdown resulted in substantial increases to operating expenses; (iii) its physician retention rate had fallen significantly below the 87% highlighted in the IPO's registration statement leading to additional costs to bring on new physicians, who were less productive than the outgoing physicians they were replacing; and (iv) as a result, LifeStance Health's business metrics and financial prospects were not as strong as the IPO's registration statement represented.
The case is Nayani v. LifeStance Health Group, Inc., No. 22-cv-06833.
ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. At ClaimsFiler.com, investors can: (1) register for free to gain access to information and settlement websites for various securities class action cases so they can timely submit their own claims; (2) upload their portfolio transactional data to be notified about relevant securities cases in which they may have a financial interest; and (3) submit inquiries to the Kahn Swick & Foti, LLC law firm for free case evaluations.
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Significantly more patients with moderate/severe symptoms of chronic rhinosinusitis at baseline improved to mild/no symptoms at week 24 after treatment with LYR-210 (7500μg) compared to control
The three cardinal symptoms composite score shown to correlate with the well-established SNOT-22 scores at week 24 in the LANTERN study
WATERTOWN, Mass., Sept. 10, 2022 /PRNewswire/ -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (the Company or Lyra), a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, announced that new LYR-210 data analyses from the Phase 2 LANTERN study will be presented today at the 68th Annual Meeting of the American Rhinologic Society (ARS) in Philadelphia.
The additional results from the previously-reported Phase 2 LANTERN study showed that LYR-210 (7500μg) significantly improved symptom severity from baseline of 3 cardinal symptoms (3CS) of chronic rhinosinusitis (CRS) – nasal blockage, nasal discharge, and facial pain/pressure – when assessed in a responder analysis as individual and composite symptom scores at week 24. Compared to control, significantly higher proportions of LYR-210-treated subjects improved from moderate or severe at baseline to mild or none at week 24 in nasal blockage, nasal discharge, and facial pain/pressure (p<0.05). Consistent with other reported data from the LANTERN study, LYR-210 demonstrated a dose-dependent response in the 3CS severity analysis.
"This new LANTERN data provides additional evidence of the potential for LYR‑210 to offer meaningful improvement of patients' CRS symptoms and quality of life," said Brent A. Senior, MD, Department of Otolaryngology – Head & Neck Surgery, University of North Carolina at Chapel Hill, and chair of the data monitoring committee for the LANTERN study who will present the LYR-210 data at ARS. "The data supports the use of the 3 cardinal symptoms (3CS) score for assessing CRS patients' symptoms, augmenting the assessment tools available in addition to SNOT-22 to guide the treatment of CRS. Consistently across all measures, LYR-210 achieved significant improvement in symptom severity and shows promise as a potential new treatment option for CRS patients who still experience debilitating symptoms with current treatment approaches."
A second oral presentation for LYR-210 at the ARS meeting will highlight the correlation between the 3CS composite scores and Sino-Nasal Outcome Test (SNOT-22) scores. The data show that the clinical changes in CRS patients measured in the 3CS composite score strongly and significantly correlate with the change in SNOT-22 total score, based on data evaluated at week 24 in the LANTERN study. Both assessments, 3CS and SNOT-22, provide critical information on a patient's response to treatment and the impact CRS has on quality of life.
"We are enthusiastic to share these results for LYR-210 with the ENT treatment community at the ARS meeting. LYR-210 is the first product candidate designed to provide six months of therapy with a single treatment for CRS patients," said Richard Nieman, M.D., Chief Medical Officer of Lyra Therapeutics. "We continue to advance LYR-210 in the ongoing ENLIGHTEN Phase 3 program as a potential new treatment for patients."
The presentations of the data announced today are available on Lyra's website.
About LANTERN Phase 2 Study
Surgically naïve adults with moderate-to-severe CRS who failed previous medical management enrolled in a multicenter, randomized (1:1:1), controlled LANTERN study. Patients received either bilateral administration of LYR-210 (2500µg) (n=23) or LYR-210 (7500µg) (n=21), or sham-procedure control (n=23). Both LYR-210 doses were safe and well-tolerated over the 24-week treatment period. LYR-210 (7500µg)-treated subjects demonstrated rapid, durable, dose-dependent, global symptom improvement, over 6 months from a single administration.
About LYR-210
LYR-210 is an investigational product candidate that utilizes Lyra's proprietary XTreoTM platform to enable six months of local, intra-nasal, anti-inflammatory therapy from a single treatment for CRS. LYR-210 is designed as a non-invasive alternative to sinus surgery for the millions of CRS patients who have failed medical management. LYR-210 is a bioresorbable polymeric matrix designed to be administered in a brief in-office procedure and is intended to deliver up to six months of continuous mometasone furoate (MF) drug therapy to the sinonasal passages. In the LANTERN Phase 2 study, LYR-210 (7500μg) demonstrated clinically meaningful, rapid, durable, dose-dependent symptom improvement over 24 weeks compared with control, based on composite Cardinal Symptoms (CS) scores and Sino-Nasal Outcome Test (SNOT-22). These results were supported in the Phase 2 LANTERN 6-month post treatment evaluation which showed a durable response in about 50% of treated CRS patients six months post LYR-210 removal. A pharmacokinetic (PK) study showed that MF blood levels were constant over the 56-day treatment period, confirming that LYR-210 delivers a steady daily dose of MF with accompanying rapid symptom relief during this time period. There are approximately 14 million patients with CRS in the US, approximately four million of whom fail current standard of care medical management.
About Chronic Rhinosinusitis (CRS)
CRS is a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities and is the fifth most common condition in people under 65. Cardinal symptoms include nasal obstruction and congestion, facial pain and pressure, nasal discharge, and olfactory loss. The prevalence of CRS in the U.S. is estimated to be 14 million, with 8 million treated annually using medical management including topical steroid sprays and oral steroids. Roughly half of those treated fail and seek alternative medical intervention. While ENT physicians perform approximately 400,000 surgeries annually for CRS, 65% of patients have recurrent symptoms and 100% require ongoing medical management. Additionally, many patients are surgery unwilling as the current procedures are invasive, not curative, and often require long recovery times.
About Lyra Therapeutics
Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra's XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The Company's current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra has two product candidates in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities: LYR-210, for surgically naïve patients, is being evaluated in the ENLIGHTEN Phase 3 clinical program, and LYR-220, for patients who have recurrent symptoms despite surgery, is being evaluated in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the U.S. that fail medical management each year. For more information, please visit lyratherapeutics.com and follow us on LinkedIn and Twitter.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the date and details of the presentations at ARS, our pipeline of product candidates, the success of the XTreo™ platform, and the success and efficacy of LYR-210. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the fact that the Company has incurred significant losses since inception and expects to incur additional losses for the foreseeable future; the Company's need for additional funding, which may not be available; the Company's limited operating history; the fact that the Company has no approved products; the fact that the Company's product candidates are in various stages of development; or the fact that the Company may not be successful in its efforts to identify and successfully commercialize its product candidates; the fact that clinical trials required for the Company's product candidates are expensive and time-consuming, and their outcome is uncertain; the fact that the FDA may not conclude that certain of the Company's product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway; the Company's inability to obtain required regulatory approvals; effects of recently enacted and future legislation; the possibility of system failures or security breaches; effects of significant competition; the fact that the successful commercialization of the Company's product candidates will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and pricing policies; failure to achieve market acceptance; product liability lawsuits; the fact that the Company relies on third parties for the manufacture of materials for its research programs, pre-clinical studies and clinical trials; the Company's reliance on third parties to conduct its preclinical studies and clinical trials; the Company's inability to succeed in establishing and maintaining collaborative relationships; the Company's reliance on certain suppliers critical to its production; failure to obtain and maintain or adequately protect the Company's intellectual property rights; failure to retain key personnel or to recruit qualified personnel; difficulties in managing the Company's growth; effects of natural disasters, terrorism and wars (including the developing conflict between Ukraine and Russia); the fact that the global pandemic caused by COVID-19 could adversely impact the Company's business and operations, including the Company's clinical trials; the fact that the price of the Company's common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public Company and any securities class action litigation. These and other important factors discussed under the caption "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 9, 2022 and its other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change.
Contact:
Kathryn Morris
The Yates Network LLC
914-204-6412
kathryn@theyatesnetwork.com
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NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- ClaimsFiler, a FREE shareholder information service, reminds investors that they have until October 17, 2022 to file lead plaintiff applications in a securities class action lawsuit against MINISO Group Holding Limited (NYSE: MNSO), if they purchased or acquired the Company's securities pursuant and/or traceable to the Company's October 2020 initial public offering (the "IPO"). This action is pending in the United States District Court for the Central District of California.
MINISO investors should visit us at https://claimsfiler.com/cases/nyse-mnso/ or call toll-free (844) 367-9658. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
MINISO and certain of its executives are charged with failing to disclose material information in its IPO Registration Statement, violating federal securities laws.
On July 26, 2022, market researcher Blue Orca Capital reported on a myriad of issues involving the China-based company, including that "there is overwhelming evidence that MINISO misleads the market about its core business" and that "Chinese corporate filings also indicate, in our view, that the chairman siphoned hundreds of millions from the public company through opaque Caribbean jurisdictions as the middleman in a crooked headquarters deal," among other things.
On this news, the price of MINISO's American Depositary Shares fell $1.08, or 14.98%, to close at $6.13, on unusually heavy trading volume.
The case is Ashraf v. MINISO Group Holding Limited, No. 22-cv-05815.
ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. At ClaimsFiler.com, investors can: (1) register for free to gain access to information and settlement websites for various securities class action cases so they can timely submit their own claims; (2) upload their portfolio transactional data to be notified about relevant securities cases in which they may have a financial interest; and (3) submit inquiries to the Kahn Swick & Foti, LLC law firm for free case evaluations.
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WASHINGTON, Sept. 9, 2022 /PRNewswire/ -- Vice President Kamala Harris highlighted the importance of climate, human spaceflight, and STEM education during the Biden-Harris Administration's second National Space Council meeting Friday, held at NASA's Johnson Space Center in Houston.
"For generations, with our allies and partners around the globe, America has led our world in the exploration and use of space," said Harris. "Our leadership has been guided by a set of fundamental principles – cooperation, security, ambition, and public trust – which is the recognition, of course, that space can and must be protected for the benefit of all people. There is so much we still don't know and so much we still haven't done – space remains a place of undiscovered and unrealized opportunity. Our test and our responsibility is to work together to guide humanity forward into this new frontier and to make real the incredible potential of space for all people."
For more than 50 years, NASA satellites have provided open-source and publicly available data on Earth's land, water, temperature, weather, and climate. Improving access to key climate information is a priority for the agency. Building on his previous announcement, NASA Administrator Bill Nelson released the first concept, and shared a new video for the Earth Information Center. The center will allow the public to see how the Earth is changing and guide decision makers to mitigate, adapt, and respond to climate change.
"Just like we use mission control to monitor operations during spaceflight, we're embarking on this effort to monitor conditions here on our home planet, and it will be available to everyone in an easy-to-access format," Nelson said.
Planning for the Earth Information Center is underway with the initial phase providing an interactive visual display of imagery and data from NASA and other government agencies. NASA Headquarters plans to house this initial interactive display with goals to expand in person and virtual access over the next five years.
The Vice President also underscored the important research conducted on the International Space Station that will enable long duration stays on the Moon and future human missions to Mars, in addition to benefits to life here on Earth.
"NASA uses the International Space Station to conduct critical research on the risks associated with future Mars missions – space radiation, isolation, and distance from Earth, just to name a few. It's also a testbed to develop the technologies we'll need for long duration stays on the Moon, where we will build an Artemis Base Camp on the surface and Gateway outpost in lunar orbit," Nelson said. "Research on the space station demonstrates that the benefits of microgravity are not just for discovery. We also develop new technologies that improve life on Earth, like treatments for cancer."
In conjunction with the meeting, NASA announced a new Space Grant K-12 Inclusiveness and Diversity in STEM (SG KIDS) opportunity that will award more than $4 million to institutions across the U.S. to help bring the excitement of NASA and STEM to traditionally underserved and underrepresented groups of middle and high school students. The announcement is a part of a broader set of commitments made by public, private, and philanthropic partners announced by the Vice President to help in the recruitment and development of the next generation of the space workforce.
SG KIDS also addresses the White House Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, as well as NASA Administrator Bill Nelson's focus on providing authentic STEM opportunities to K-12 students.
While at NASA's Johnson Space Center, Vice President Harris toured the agency's mission control with Nelson and Johnson Center Director Vanessa Wyche. The Vice President also spoke with NASA astronauts Bob Hines, Kjell Lindgren, and Jessica Watkins, living and working aboard the International Space Station about how their research benefits life on Earth, supports long duration space flight, and protects our planet.
The Vice President also received a tour of the Space Vehicle Mockup Facility (SVMF), where space flight crews and their support personnel receive world class training on high-fidelity hardware for real-time mission support. The SVMF consists of space station, Orion, Commercial vehicle mockups, part-task trainers and rack interfaces, a Precision Air Bearing Floor, and a Partial Gravity Simulator.
A recording of the full National Space Council meeting is available online at:
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New space boasts 30% bigger footprint with sustainable building features and offers a larger selection, grand re-opening discounts, giveaways and festivities
LAKEWOOD, Colo., Sept. 9, 2022 /PRNewswire/ -- Natural Grocers®, the largest family-operated organic and natural grocery retailer in the U.S., is pleased to announce the relocation of its Cheyenne, WY store to a newly renovated and larger space Friday, September 23rd. At 8:20 a.m. Natural Grocers' good4u® Crew will host an official ribbon-cutting and donation ceremony with Mayor Patrick Collins and Food Bank of Wyoming's Graham Brown at the new location at 1851 Dell Range Blvd. Additional community leaders will help welcome the Cheyenne community into the new store at 8:30 a.m. with gift card giveaways, fantastic discounts, prize sweepstakes and more.
"The Cheyenne Natural Grocers good4u® Crew has been proud to serve the community since the original location opened in 2010, which marked Natural Grocers' first store in Wyoming, followed by our store in Casper in 2011. We're excited to give our Cheyenne customers more space to shop, which also means new product offerings throughout all departments," said Raquel Isely, Vice President of Marketing for Natural Grocers. "We're also thrilled to have several notable community leaders joining us for our festivities, including Mayor Collins and representatives from Food Bank of Wyoming, the Cheyenne Police Department and the Cheyenne City Council. We invite everyone to visit our new store, join in the fun and discover what makes the Natural Grocers shopping experience exceptional."
GRAND RE-OPENING EVENTS — SWEEPSTAKES & DISCOUNTS
Grand Re-opening events and discounts starting September 23rd include:
- Mystery Gift Cards for First 150 Customers: The first 150 customers in line on September 23rd will receive a mystery Natural Grocers gift card (with varying amounts between $5 - $500)![i]
- Prize Wheel: Customers can spin the Natural Grocers prize wheel on September 23rd for a chance to win fun prizes.[ii]
- Grand Opening Sweepstakes[iii] : From September 23rd – October 7th, customers will have the chance to win fabulous prizes, such as an Aventon e-bike, a $500 Natural Grocers gift card and more. Entry forms will be available at the store.
- Special Grand Re-opening Discounts: Customers will enjoy exceptional discounts in every department from September 23rd – October 31st.[iv]
- For even more savings, customers can join {N}power® Natural Grocers' free loyalty program for exclusive discounts, digital coupons, rewards benefits, and other members-only features.[vi]
WHAT'S NEW?
Supported by its good4u Crew, the new store is 30% bigger and will feature a noticeably bigger product selection: particularly produce, refrigerated items and supplements. The contemporary layout will also include a Nutrition Education Center, which is a community space for in-store classes, recipe demonstrations and guest speaker events. Customers will enjoy a modern and efficient, yet friendly checkout experience. The company, ever-conscious of its environmental impact, has upgraded the new space with sustainable building features and energy-saving innovations, such as non-toxic building materials and 100% LED lighting, for a lighter environmental footprint.
WHAT STAYS THE SAME?
Serving customers with a wide range of natural and organic options since 1955, Natural Grocers will continue to support the Cheyenne community with world-class customer service from its knowledgeable and friendly good4u Crew, healthy recipes for all diets and high product standards. Customers can enjoy access to fresh, 100% USDA certified organic produce, high-quality organic and natural groceries, 100% free-range eggs, 100% pasture-based dairy, 100% non-GMO prepackaged bulk goods, dietary supplements, body care, and household essentials at an Always Affordable PriceSM. Natural Grocers also prioritizes humanely sourced and sustainably raised meats.
The Cheyenne community will continue to have the support of Natural Grocers' Nutritional Health Coaches (NHC's) for their health and wellness journeys with free, one-on-one personalized nutritional health coaching sessions. Customers are invited to book a free session, which are currently available in person, via phone or video, by visiting www.naturalgrocers.com/nutritional-health-coaches.
FOOD BANK OF WYOMING PARTNERSHIP
Known for its community outreach, Natural Grocers has partnered with Food Bank of Wyoming since 2013 for its "Bring Your Own Bag" program. Each time a customer brings their own bag, Natural Grocers donates five cents per shopping trip to the Food Bank, which provides food and necessities to people in need across the state.
"Natural Grocers has been supporting Food Bank of Wyoming since 2013. As the statewide food bank, we serve all twenty-three counties through 160 hunger relief partners. It's relationships like the one we have with Natural Grocers, plus being a part of the Feeding America network, which enables us to stretch every dollar donated into four meals. Every donation, whether big or small, truly ads up. When you shop at Natural Grocers and bring your own bag, you are joining the fight to end hunger," said Jill Stillwagon, Director of Development for Food Bank of Wyoming
September is also Hunger Action Month®, and the date of Natural Grocers' Grand Re-location (September 23rd) coincides with Hunger Action Day®. Graham Brown, the Development Coordinator from Food Bank of Wyoming will be onsite for the ribbon cutting ceremony and to accept a special donation of $2,500 from Natural Grocers to support Hunger Action Day and Wyoming communities facing hunger.
- Click here to learn more about Natural Grocers.
- To join {N}power, visit www.naturalgrocers.com/npower.
- Click here to learn more about Food Bank of Wyoming and Hunger Action Month.
- Media kit & assets, courtesy of Natural Grocers.
- For media inquiries contact Katie Macarelli, Manager of Public Relations at kmacarelli@naturalgrocers.com.
ABOUT NATURAL GROCERS BY VITAMIN COTTAGE
Natural Grocers by Vitamin Cottage, Inc. (NYSE: NGVC) is an expanding specialty retailer of natural and organic groceries, body care products, and dietary supplements. The products sold by Natural Grocers must meet strict quality guidelines and may not contain artificial colors, flavors, preservatives or sweeteners, or partially hydrogenated or hydrogenated oils. The Company sells only USDA-certified organic produce and exclusively pasture-raised, non-confinement dairy products, and free-range eggs. Natural Grocers' flexible smaller-store format allows it to offer affordable prices in a shopper-friendly, clean, and convenient retail environment. The Company also provides extensive free science-based Nutrition Education programs to help customers make informed health and nutrition choices. The Company, founded in 1955, has 163 stores in 21 states. Visit https://www.naturalgrocers.com for more information and store locations.
[i] Quantity limited to first 150 customers in line at Natural Grocers Cheyenne –1851 Dell Range Blvd. Cheyenne, WY 82009; no rain checks. Limit one gift card per customer 18 years or older. Valid 9/23/22 only. Void where prohibited by law.
[ii] No purchase necessary. Quantity limited to stock on hand; no rain checks.
[iii] No purchase necessary. A purchase or payment of any kind will not increase your chances of winning. Open only to legal residents of the 50 United States and the District of Columbia, 18 years or older. Void where prohibited by law. Sweepstakes starts on September 23, 2022 and ends on October 7, 2022. Winner will be contacted directly by store after October 7, 2022. For Official Rules and complete details, see store or visit: www.naturalgrocers.com/sweepstakes. Sponsor: Vitamin Cottage Natural Food Markets, Inc.
[iv] Unless otherwise noted, offers are available only from 9/23/22 to 10/31/22 and are redeemable only for in-store customer purchases at Natural Grocers Cheyenne, WY location. All discounts are on regular prices and cannot be redeemed for store credit or cash and cannot be combined with other offers. Pricing excludes taxes and is subject to change without notice. Quantity limited to stock on hand; no rain checks. Natural Grocers reserves the right to correct errors. Void where prohibited by law.
[v] Bacon/Bacon Alternatives and Cheese Shreds and Slices: limit 3 per customer. Offers valid only from 9/23/22 to 10/31/22, are redeemable only for in-store customer purchases at Natural Grocers Cheyenne, WY location and cannot be combined with other offers. Quantity limited to stock on hand; no rain checks. Pricing excludes taxes and is subject to change without notice. Natural Grocers reserves the right to correct errors. Void where prohibited by law.
[vi] Customers can sign up for {N}power here. Message and data rates may apply. See naturalgrocers.com/privacy for our Privacy Policy and naturalgrocers.com/terms for the {N}Power terms of use.
[vii] Must be an {N}power member to receive these discounts. Offers valid only from 9/23/22 to 10/31/22, are redeemable only for in-store customer purchases at Natural Grocers Cheyenne, WY location and cannot be combined with other offers. Quantity limited to stock on hand; no rain checks. Pricing excludes taxes and is subject to change without notice. Natural Grocers reserves the right to correct errors. Void where prohibited by law. Eggs: limit 4 per customer; avocados: limit 4 per customer. Excludes green beans.
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The Exhibition, which celebrates Disney 100 Years of Wonder, launches a World Tour at Philadelphia's Franklin Institute on February 18, 2023, with next stops announced, including Chicago, IL, Kansas City, MO, and Munich, Germany
PHILADELPHIA, Sept. 10, 2022 /PRNewswire/ -- Today at D23 Expo: The Ultimate Disney Fan Event in Anaheim, CA, exciting new details and stops were announced for the upcoming world premiere of Disney100: The Exhibition. Created for the 100-year celebration of The Walt Disney Company, the exhibition will immerse guests in the beloved stories that have been dazzling guests since 1923, when Walt Disney set his company on a path that would revolutionize the entertainment industry. The world premiere of the exhibit opens on February 18, 2023, at The Franklin Institute in Philadelphia, PA, with Chicago, IL, and Kansas City, MO, set as the next two stops on the North American tour. The international unit of the exhibit will open on April 18, 2023, in Munich, Germany, with more cities to be announced in the coming months.
The official exhibition poster and trailer were also revealed today.
Disney100: The Exhibition Poster
Disney100: The Exhibition Trailer
"As we prepare to kick off Disney 100 Years of Wonder, we are incredibly excited to bring this fantastic exhibition to life," said Becky Cline, director, Walt Disney Archives. "We can't wait for guests to experience their favorite Disney stories, characters, and attractions in new and immersive ways as we celebrate all the wonderful worlds of Disney."
President and CEO of The Franklin Institute Larry Dubinski added, "The Franklin Institute is thrilled to host Disney100: The Exhibition, the first major event to mark the global celebration of Disney's 100 years, allowing fans throughout the Philadelphia region and beyond the very first opportunity to see these crown jewels come to life in beautifully crafted galleries reflecting the creative empire synonymous with imaginative storytelling, innovation, discovery, and wonder."
Over the past 100 years, Disney has brought its iconic stories and characters to life in new and innovative ways, becoming part of the global culture and creating generations of memories for billions. Disney100: The Exhibition invites guests to step into their favorite stories using innovation and immersive technology throughout ten galleries in the 15,000-square-foot exhibit.
The Walt Disney Archives opens its vault of treasures, showcasing hundreds of extraordinary objects, including many of Disney's "Crown Jewels" - more than 250 rarely seen original artworks and artifacts, costumes and props, and other memorabilia. Disney has curated special behind-the-scenes glimpses into the creation of the most popular characters, films, shows, and attractions – from Disneyland to Walt Disney World® Resort and beyond. The ten magnificent and imaginatively themed galleries, with moving stories, unique interactive installations, and exciting background information, will take visitors on a journey through 100 years of The Walt Disney Company, celebrating the classics from Snow White and the Seven Dwarfs to Strange World, as well as the latest members of the Disney family – Pixar, Star Wars, Marvel, and National Geographic.
Disney100: The Exhibition Facts:
-Ten large, themed galleries with numerous cutting-edge interactive installations covering 15,000 square feet
-February 18, 2023: World Premiere at The Franklin Institute in Philadelphia, launching the U.S. tour
-April 18, 2023: European Premiere in Munich
-Created and curated by the Walt Disney Archives and Semmel Exhibitions
The Franklin Institute is proud to present and play host to the world premiere of Disney100: The Exhibition in the Nicholas and Athena Karabots Pavilion and the Mandell Center. PECO, the premier corporate partner of The Franklin Institute, is the Local Presenting Sponsor of the exhibition.
About The Franklin Institute
Located in the heart of Philadelphia, The Franklin Institute is a renowned and innovative leader in science and technology learning and a dynamic center of activity. As Pennsylvania's most visited museum, it is dedicated to creating a passion for learning about science by offering access to hands-on science education. For more information, visit www.fi.edu.
About the Walt Disney Archives
For more than 50 years, the Walt Disney Archives has carefully safeguarded the most treasured items from The Walt Disney Company's history, including original scripts, movie props and costumes, Walt Disney's correspondence and script notes, theme park artifacts, merchandise, millions of archival photographs, and many of Walt's personal effects. Founded by Disney Legend Dave Smith in 1970, the Walt Disney Archives is a vital resource for every part of Disney, as well as an important research center for Disney scholars, researchers, and writers. The Archives also shares its countless pieces with Disney fans everywhere through its exhibitions and close association with D23: The Official Disney Fan Club.
For the Walt Disney Archives:
Jeffrey R. Epstein
The Walt Disney Company
[email protected]
About Semmel Exhibitions
Semmel Exhibitions creates exhibitions, which travel worldwide, and hosts international exhibitions in Germany, Austria, and German-speaking Switzerland. Semmel Exhibitions is a division of Semmel Concerts Entertainment, the large German live entertainment producer. Since Semmel Exhibitions started touring its exhibitions TUTANKHAMUN – HIS TOMB AND HIS TREASURES; THE DISCOVERY OF KING TUT; and most recently MARVEL: UNIVERSE OF SUPER HEROES and SPIDER-MAN: BEYOND AMAZING – THE EXHIBITION, they have reached an audience of more than seven million people worldwide, and built a strong international network within museums, science centers, cultural venues and the creative industries. More information at semmel-exhibitions.com.
Media Contact:
Stefanie Santo
The Franklin Institute
[email protected] 215.448.1152
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- Nature's Miracle is a fast-growing agriculture technology company providing services to growers in Controlled Environment Agriculture ("CEA") settings in North America;
- Nature's Miracle provides hardware as well as software to design, build and operate various indoor growing settings including greenhouse, vertical farming and indoor-growing spaces;
- Nature's Miracle, through its two wholly-owned subsidiaries, Visiontech Group, Inc. and Hydroman, Inc., provides grow lights as well as other hydroponic products to hundreds of indoor growers in North America;
- Nature's Miracle has also developed a robust pipeline to build commercial-scale greenhouse in the U.S. and Canada to meet the growing needs of fresh and local vegetable products. The Company offers turnkey solutions to its operating partners by providing design, construction and hardware installment services;
- Nature's Miracle has established its first manufacturing footprint in North America with its grow-light assembly plant in Manitoba, Canada and is expecting to set up additional manufacturing/assembly facilities in North America;
- The implied pro-forma enterprise value of the combined company is approximately $265 million, assuming no redemptions from the trust account. The business combination is expected to be completed in the first quarter of 2023;
- This transaction is expected to accelerate Nature's Miracle's development of commercial greenhouse in the U.S. and Canada.
UPLAND, Calif., Sept. 9, 2022 /PRNewswire/ -- Nature's Miracle Inc. ("Nature's Miracle"), a leader in the Controlled Environment Agriculture Industry, and Lakeshore Acquisition II Corp. ("together with its successors, Lakeshore") (Nasdaq: LBBB) today announced that they have entered into a definitive business combination agreement (the "Merger Agreement"). Upon closing, the combined company is expected to change its name to Nature's Miracle Holding Inc. and its common stock is expected to be traded on the Nasdaq Global Market.
Management Comments
"In the face of global energy shortage, food security, drought and life-style change, Nature's Miracle is excited to offer an alternative farming mode which saves transportation cost, reduces irrigation water requirements by up to 90% and ensures fresh and local supply of produces for health-conscious consumers. We have developed a robust pipeline of greenhouse projects in the U.S. and Canada for the next twenty-four months," said Tie "James" Li, Founder, Chairman and Chief Executive Officer of Nature's Miracle. "By combining with Lakeshore, Nature's Miracle will be able to tap into the public equity and debt market to fund its aggressive growth plan going forward. We look forward to working with Lakeshore team to complete the transaction and to list on Nasdaq."
"We are thrilled to partner with Nature's Miracle on its public company journey," said Bill Chen, Chairman and Chief Executive Officer of Lakeshore. "After learning of Nature's Miracle's business model and its position in the rapidly growing Controlled Environment Agriculture market, we immediately realized the vast potential for the Company's growth in this very important market segment."
Key Transaction Terms
Pursuant to the Merger Agreement, Nature's Miracle will merge with LBBB Merger Sub Inc., a Delaware corporation and a wholly-owned subsidiary of Lakeshore (the "Merger"), with Nature's Miracle surviving and Lakeshore acquiring 100% of the equity securities of Nature's Miracle. In exchange for their equity securities, the stockholders of Nature's Miracle (the "Company Stockholders") will receive an aggregate number of shares of common stock of Lakeshore (the "Merger Consideration") with an aggregate value equal to: (a) two hundred thirty million U.S. dollars ($230,000,000), minus (b) any Closing Net Indebtedness (as defined in the Merger Agreement).
The Merger has been approved by the boards of directors of each of Lakeshore and Nature's Miracle. The Merger will require the approval of the stockholders of Lakeshore and Nature's Miracle and is subject to other customary closing conditions, including a registration statement on Form S-4 being declared effective by the U.S. Securities and Exchange Commission. The transaction is expected to close in the first quarter of 2023.
Advisors
Hunter Taubman Fischer & Li LLC. is acting as legal advisor to Nature's Miracle and Loeb & Loeb is acting as legal advisor to Lakeshore. Maxim Group is acting as M&A advisor to Lakeshore.
Management Presentation
A presentation made by the management teams of both Nature's Miracle and Lakeshore regarding the transaction will be available on the websites of Nature's Miracle at https: //www.Nature-Miracle.com and Lakeshore at https://www.lakeshoreacquisition.com/tzzy. Lakeshore will also file the presentation with the SEC in a Current Report on Form 8-K, which will be accessible at www.sec.gov.
About Lakeshore Acquisition II Corp.
Lakeshore Acquisition II Corp. is a blank check company, also commonly referred to as a special purpose acquisition company, or SPAC, formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities.
About Nature's Miracle Holdings Inc.
Nature's Miracle is a fast-growing agriculture technology company providing services to growers in the Controlled Environment Agriculture ("CEA") industry which also include vertical farming in North America. The Company offers integrated solutions which include hardware as well as software to design, build and operate various indoor growing settings including greenhouse and indoor-growing spaces. Nature's Miracle, through its two wholly-owned subsidiaries, Visiontech Group, Inc. and Hydroman, Inc., provides grow lights as well as other hydroponic products to hundreds of indoor growers in North America. Nature's Miracle has also developed a robust pipeline to build commercial-scale greenhouse in the U.S. and Canada to meet the growing needs of fresh and local vegetable products. The Company offers turnkey solutions to its operating partners by providing the design, construction and hardware installment services; Nature's Miracle has established its first manufacturing footprint in North America with its grow-light assembly plant in Manitoba, Canada and is expected to set up additional manufacturing/assembly facilities in North America.
Important Information About the Proposed Business Combination and Where to Find It
This press release relates to a proposed business combination between Lakeshore and Nature's Miracle. A full description of the terms of the business combination will be provided in a Registration Statement on Form S-4 and proxy statement to be filed with the SEC by Lakeshore. The proxy statement will be mailed to Lakeshore's shareholders as of a record date to be established for voting at the shareholders' meeting relating to the proposed transactions. This press release does not contain all the information that should be considered concerning the proposed business combination and is not intended to form the basis of any investment decision or any other decision in respect of the proposed business combination. Lakeshore's shareholders and other interested persons are advised to read, when available, the Registration Statement on Form S-4 and proxy statement and the amendments thereto and other documents filed in connection with the proposed business combination, as these materials will contain important information about Nature's Miracle, Lakeshore and the proposed business combination. The Registration Statement on Form S-4 and the proxy statement and other documents filed with the SEC, once available, may be obtained without charge at the SEC's website at www.sec.gov, or by directing a written request to Lakeshore, 667 Madison Avenue, New York, NY 10065.
Participants in the Solicitation
Lakeshore, certain shareholders of Lakeshore, and their respective directors and executive officers may be deemed participants in the solicitation of proxies from Lakeshore's shareholders with respect to the proposed business combination. A list of the names of Lakeshore's directors and executive officers and a description of their interests in Lakeshore is contained in Lakeshore's registration statement on Form S-1, which was filed with the SEC and is available free of charge at the SEC's web site at www.sec.gov, or by directing a written request to Lakeshore, 667 Madison Avenue, New York, NY 10065. Additional information regarding the interests of such participants will be contained in the Registration Statement on Form S-4 and proxy statement for the proposed business combination when available.
Nature's Miracle and its directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of Lakeshore in connection with the proposed business combination. A list of the names of such directors and executive officers and information regarding their interests in the proposed business combination will be included in the proxy statement for the proposed business combination when available.
Forward-looking Statements
Except for historical information contained herein, this press release contains certain "forward-looking statements" within the meaning of the federal U.S. securities laws with respect to the proposed business combination between Lakeshore and Nature's Miracle, the benefits of the transaction, the amount of cash the transaction will provide Nature's Miracle, the anticipated timing of the transaction, the services and markets of Nature's Miracle, our expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities, future plans and intentions, results, level of activities, performance, goals or achievements or other future events. These forward-looking statements generally are identified by words such as "anticipate," "believe," "expect," "may," "could," "will," "potential," "intend," "estimate," "should," "plan," "predict," or the negative or other variations of such statements, reflect our management's current beliefs and assumptions and are based on the information currently available to our management. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual results or developments to differ materially from those expressed or implied by such forward-looking statements, including but not limited to: (i) the risk that the transaction may not be completed in a timely manner or at all, which may adversely affect the price of Lakeshore's securities; (ii) the risk that the transaction may not be completed by Lakeshore's business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by Lakeshore; (iii) the failure to satisfy the conditions to the consummation of the transaction, including the approval of the business combination agreement by the stockholders of Lakeshore, the satisfaction of the minimum cash amount following any redemptions by Lakeshore's public stockholders and the receipt of certain governmental and regulatory approvals; (iv) the lack of a third-party valuation in determining whether or not to pursue the proposed transaction; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the business combination agreement; (vi) the effect of the announcement or pendency of the transaction on Nature's Miracle's business relationships, operating results and business generally; (vii) risks that the proposed transaction disrupts current plans and operations of Nature's Miracle; (viii) the outcome of any legal proceedings that may be instituted against Nature's Miracle or Lakeshore related to the business combination agreement or the proposed transaction; (ix) the ability to maintain the listing of Lakeshore's securities on a national securities exchange; (x) changes in the competitive industries in which Nature's Miracle operates, variations in operating performance across competitors, changes in laws and regulations affecting Nature's Miracle's business and changes in the combined capital structure; (xi) the ability to implement business plans, forecasts and other expectations after the completion of the proposed transaction, and identify and realize additional opportunities; (xii) the risk of downturns in the market and Nature's Miracle's industry including, but not limited to, as a result of the COVID-19 pandemic; (xiii) costs related to the transaction and the failure to realize anticipated benefits of the transaction or to realize estimated pro forma results and underlying assumptions, including with respect to estimated stockholder redemptions; (xiv) risks and uncertainties related to Nature's Miracle's business, including, but not limited to risks relating to the uncertainty of the projected financial information with respect to Nature's Miracle; risks related to Nature's Miracle's limited operating history, the roll-out of Nature's Miracle's business and the timing of expected business milestones; Nature's Miracle's ability to implement its business plan and scale its business; Nature's Miracle's ability to develop products and technologies that are more effective or commercially attractive than competitors' products; Nature's Miracle's ability to maintain accelerate rate of growth recently due to lifestyle changes in the wake of COVID-19 pandemic; risks of increased costs as a result of being a public company; risks relating to Nature's Miracle's being unable to renew the leases of their facilities and warehouses; Nature's Miracle's ability to grow the size of its organization and management in response of the increase of sales and marketing infrastructure; risks relating to potential tariffs or a global trade war that could increase the cost of Nature's Miracle's products; risks relating to product liability lawsuits that could be brought against Nature's Miracle;; Nature's Miracle's ability to formulate, implement and modify as necessary effective sales, marketing, and strategic initiatives to drive revenue growth; Nature's Miracle's ability to expand internationally; acceptance by the marketplace of the products and services that Nature's Miracle markets; and government regulations and Nature's Miracle's ability to obtain applicable regulatory approvals and comply with government regulations. The foregoing list of factors is not exclusive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of proxy statement, when available, and other documents filed by Lakeshore from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date on which they are made, and neither Nature's Miracle nor Lakeshore assume any obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Neither Lakeshore nor Nature's Miracle gives any assurance that either Lakeshore or Nature's Miracle, or the combined company, will achieve its expectations.
Non-solicitation
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential business combination or any other matter and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Lakeshore, Nature's Miracle or the combined company, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.
Contacts
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- Analyses included 100-week efficacy and safety data from the four-year, open-label extension period of KEEPsAKE 1 and 2 evaluating SKYRIZI in patients with active psoriatic arthritis1
- Ongoing treatment with SKYRIZI demonstrated consistent long-term efficacy in psoriatic arthritis with similar rates of improvement in skin (PASI 90) and joint (ACR, enthesitis, dactylitis) symptoms at week 100 as those reported at week 521
- No new safety signals were observed through 100 weeks1-4
NORTH CHICAGO, Ill., Sept. 10, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced new, long-term data analyses of KEEPsAKE 1 and 2, Phase 3 trials evaluating SKYRIZI® (risankizumab, 150 mg) in adult patients with active psoriatic arthritis. Results showed that at week 100 of the open-label extension period, patients receiving SKYRIZI reported improvement in skin and joint symptoms, with more than half of patients in KEEPsAKE 1 and 2 achieving a 90 percent reduction in the Psoriasis Area and Severity Index (PASI 90) and an American College of Rheumatology 20 (ACR20) response. Additionally, the data demonstrated no new observed safety signals through 100 weeks.1-4 These results were featured during the "Late Breaking News" session at the 31st European Academy of Dermatology and Venereology (EADV) Hybrid Congress onsite in Milan and online.
"We're pleased to share these new, nearly two-year analyses, which showed SKYRIZI maintained improvements across joint and skin measures of psoriatic arthritis over time," said Doina Cosma-Roman, M.D., vice president and global head, Clinical Development, Immunology, AbbVie. "It is critically important for physicians to have treatment options that demonstrate lasting efficacy, as we know people living with psoriatic arthritis discontinue therapies due to loss of efficacy or tolerability."
The new data from the open-label extension period showed that at 100 weeks, 64 and 57 percent of patients initially treated with SKYRIZI achieved ACR20 response in KEEPsAKE 1 and 2, respectively.1 Additionally, at week 100, 71 and 67 percent of patients from KEEPsAKE 1 and 2, respectively, initially treated with SKYRIZI and who had a body surface area involvement greater than or equal to ≥3 percent at baseline, achieved PASI 90.1
Furthermore, at week 100, pooled results from KEEPsAKE 1 and 2 showed that 76 and 57 percent of patients, respectively, initially treated with SKYRIZI achieved resolution of dactylitis and enthesitis.1 For patients in KEEPsAKE 1 with nail psoriasis at baseline and who were initially treated with SKYRIZI, mean scores for Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and modified Nail Psoriasis Severity Index (mNAPSI) were maintained at week 100 compared with week 52.1
"Psoriatic arthritis often presents with musculoskeletal symptoms, including pain and swelling in the knees, wrists, ankles and fingers, as well as pain in the hips and heels, which can significantly reduce a person's quality of life," said Lars Erik Kristensen, M.D., Ph.D., consultant and head of science at the Parker Institute in Copenhagen, Denmark and associate professor, SUS University Hospital in Lund, Sweden. "These results highlight SKYRIZI's potential to relieve symptoms in both biologic-naïve and -experienced patients with active psoriatic arthritis in the long-term."
SKYRIZI was generally well-tolerated, and no new safety signals were noted in both KEEPsAKE 1 and 2 at 100 weeks of treatment.1-4 Serious treatment-emergent adverse events (TEAEs) occurred at 7.6 events/100 patient-years (E/100PY) and 9.9 E/100PY in KEEPsAKE 1 and 2, respectively.1 Rates of serious infections in KEEPsAKE 1 and 2 were 2.3 and 1.6 E/100PY, respectively.1 Major adverse cardiac events (MACE) occurred at 0.1 E/100PY in KEEPsAKE 1 and 0.5 E/100PY in KEEPsAKE 2.1 The rates of TEAEs leading to discontinuation of the study drug in KEEPsAKE 1 was 2.1 E/100PY and 1.2 E/100PY in KEEPsAKE 2.1 There were six deaths in KEEPsAKE 1, which were not related to the study drug, per investigator.1* In KEEPsAKE 2, there was one death not related to the study drug, per investigator.1
SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
About Psoriatic Arthritis
Psoriatic arthritis is a heterogeneous, systemic and inflammatory disease with hallmark manifestations across multiple domains including joints and skin.5,6 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.5,6
About KEEPsAKE 1 and 21-4,7,8
KEEPsAKE 1 and 2 are both Phase 3, multicenter, randomized, double-blind and placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE 1 included patients with an inadequate response or intolerance to one or more conventional synthetic disease modifying antirheumatic drugs (csDMARD-IR), while KEEPsAKE 2 included patients with an inadequate response to csDMARD-IR and/or with an inadequate response or intolerance to one or two biologic therapies. In the first phase of the studies (Period 1), patients were randomized to SKYRIZI or placebo through week 24. At week 24, the open-label extension (Period 2) began, and all patients were treated with SKYRIZI.
The two studies are ongoing to evaluate the long-term safety, tolerability and efficacy of SKYRIZI in patients with psoriatic arthritis.
More information on these trials can be found at www.clinicaltrials.gov (KEEPsAKE 1: NCT03675308; KEEPsAKE 2: NCT03671148).
About SKYRIZI® (risankizumab)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.9,10 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic, immune-mediated diseases, including psoriasis.9 SKYRIZI is approved in the U.S. to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, as well as to treat active psoriatic arthritis in adults.11 In the EU, SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy; SKYRIZI, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).10 The approved dose for SKYRIZI is 150 mg (one 150 mg pre-filled pen or pre-filled syringe) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter.10 Phase 3 trials of SKYRIZI in psoriatic arthritis, psoriasis, Crohn's disease and ulcerative colitis are ongoing.12-14
EU Indications and Important Safety Information about SKYRIZI® (risankizumab)10
Indications
Skyrizi (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Important Safety Information
Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.
The most frequently reported adverse reactions were upper respiratory infections. Commonly (≥ 1/100 to < 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.
This is not a complete summary of all safety information.
See SKYRIZI full summary of product characteristics (SmPC) at www.ema.europa.eu.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Dermatology
For more than a decade, AbbVie has worked to uncover new solutions and improve care for people with serious skin diseases, including psoriasis, psoriatic arthritis, hidradenitis suppurativa and atopic dermatitis. With a broad clinical trial program, we continue to actively research and adapt to the evolving needs of the dermatology community and advance our pipeline to help people achieve their treatment goals and live beyond their skin disease. For more information on AbbVie in dermatology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/dermatology.html.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
References:
- Kristensen, L.E., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Trials. 2022 European Academy of Dermatology and Venereology (EADV) Hybrid Congress.
- Kristensen, L.E., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 52-Week Results From the KEEPsAKE 1 and KEEPsAKE 2 Trials. 2021 European Academy of Dermatology and Venereology Virtual Congress.
- Kristensen, L.E., et al. Efficacy and Safety of Risankizumab in Patients With Active Psoriatic Arthritis After Inadequate Response or Intolerance to DMARDs: 24-Week Results From the Phase 3, Randomized, Double-Blind KEEPsAKE 1 Trial. 2021 World Psoriatic and Arthritis Conference.
- Östör, A., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Including Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-Week Results From the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial.
- Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
- Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed August 17, 2022.
- A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1). clinicaltrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed August 17, 2022.
- A Phase 3, Randomized, Double-Blind Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies) (KEEPsAKE 2). clinicaltrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed August 17, 2022.
- Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu/en/documents/product- information/skyrizi-epar-product-information_en.pdf. Accessed August 17, 2022.
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.; 2022.
- A Study of the Efficacy and Safety of Risankizumab in Participants with Crohn's Disease. clinicaltrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed August 17, 2022.
- A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants with Moderately to Severely Active Ulcerative Colitis. clinicaltrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed August 17, 2022.
- Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed August 17, 2022.
* In KEEPsAKE 1, there were six subjects with fatal events, but seven different events were reported.
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SOURCE AbbVie | https://www.ktre.com/prnewswire/2022/09/10/new-late-breaking-results-phase-3-trials-skyrizi-risankizumab-evaluating-long-term-effect-skin-joint-symptoms-patients-with-psoriatic-arthritis-week-100/ | 2022-09-10T19:02:50 | en | 0.921316 |
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First-in-class Phase 1 data presented at ESMO for ubamatamab (REGN4018; MUC16xCD3) in recurrent ovarian cancer and REGN5093 (METxMET) in MET-altered advanced non-small cell lung cancer
TARRYTOWN, N.Y., Sept. 10, 2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive early data for two novel and investigational bispecific antibodies – ubamatamab (REGN4018; MUC16xCD3) in recurrent ovarian cancer and REGN5093 (METxMET) in MET-altered advanced non-small cell lung cancer (NSCLC). The initial safety and efficacy results are from the dose-escalation portions of two Phase 1/2 trials and are being presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris.
"Bispecific antibodies are an important component of our oncology pipeline because of their flexibility to potentially address a variety of cancers," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "At ESMO, we're showcasing this flexibility with ubamatamab and REGN5093, two novel bispecific antibodies that are initially being investigated as monotherapies for recurrent ovarian cancer and MET-altered advanced lung cancer, respectively. They were among the first in our pipeline to progress into clinical trials for solid tumors, and we're encouraged to see both showing anti-tumor activity in dose escalation. These first-in-class results give us confidence in our VelociBi® bispecific development platform, and we look forward to investigating ubamatamab and REGN5093 further."
As shared in a mini-oral at ESMO, ubamatamab is a CD3-targeting bispecific under investigation for recurrent ovarian cancer and designed to bridge MUC16 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation. Dose-escalation results were presented for 78 patients with recurrent ovarian cancer who had received a median of 4.5 prior treatments, including platinum-based chemotherapy and a median duration of exposure to ubamatamab was 12 weeks (range: <1 to 145 weeks).Within 42 patients who received ≥1 full doses of ≥20 mg ubamatamab, a 14% (6 of 42 patients) overall response rate (ORR) was achieved across dose levels. The ORR increased to 21% (6 of 29 patients) in those without visceral metastases (exploratory subset) and 31% (4 of 13 patients) in those with high MUC16-expressing tumors (preliminary exploratory subset). Across dose levels, the disease control rate was 57% (24 of 42 patients), and the median duration of response was 12 months per Kaplan-Meier estimates (range: 4 to ≥24 months).
Safety was assessed in 78 ubamatamab-treated patients, with the most common adverse events (AEs) in ≥15% being cytokine release syndrome (74%, all ≤grade 2), pain (87%) and anemia (51%). AEs that were ≥grade 3 occurred in 65% of patients with those in >5% including anemia (24%), pain (23%) and neutropenia (8%). There was one instance of a dose-limiting toxicity (neutropenia) and three deaths due to AEs, none of which were considered related to treatment by sponsor assessment. Based on these efficacy and safety data, the Phase 2 portion of the trial is enrolling patients with platinum-resistant ovarian cancer to further investigate ubamatamab as a monotherapy and in combination with Regeneron's PD-1 inhibitor Libtayo® (cemiplimab).
Preliminary first-in-human results for REGN5093 were also published in an ESMO scientific abstract, with updated data and additional response rates to be detailed in a poster session on Monday, September 12. REGN5093 is a tumor-targeting bispecific designed to bind to the MET receptor in two places and trigger rapid internalization of this complex into cancer cells to degrade the MET receptor and block its ability to support cell proliferation. As highlighted in the abstract, among 36 patients with MET-altered advanced NSCLC who received the highest dose tested to date, 6 experienced a partial response with 5 of these responses occurring in patients who had received prior anti-PD-1 treatment. Total exposure to treatment was approximately 467 patient-weeks.
AEs that were ≥grade 3 occurred in 25% (n=11) of REGN5093-treated patients, with pneumonia and pulmonary embolism each occurring in 2 patients. One patient discontinued treatment due to increased alanine aminotransferase and aspartate aminotransferase. No dose-limiting toxicities or treatment-related deaths have been observed as of data cutoff. These early efficacy and safety data support further dose expansions, and a separate Phase 1/2 trial is ongoing to investigate an antibody-drug conjugate format of REGN5093 (REGN5093-M114).
The potential uses of ubamatamab, Libtayo, REGN5093 and REGN5093-M114 described above are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
About Regeneron in Oncology
At Regeneron, we're applying more than three decades of scientific innovation with the goal of developing paradigm-changing therapies for patients with cancer. Our oncology portfolio is built around two foundational approaches – our approved PD-1 inhibitor Libtayo and investigational bispecific antibodies – which are being evaluated both as monotherapies and in combination with emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop potentially synergistic treatments for a wide range of solid tumors and blood cancers.
If you are interested in learning more about our clinical trials, please contact us (clinicaltrials@regeneron.com or 844-734-6643) or visit our clinical trials website.
About Regeneron's VelocImmune® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies. This includes REGEN-COV® (casirivimab and imdevimab), Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab and odesivimab-ebgn).
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation ubamatamab (a MUC16xCD3 bispecific antibody), REGN5093 (a METxMET bispecific antibody), and Regeneron's other investigational bispecific antibodies discussed or referenced in this press release (as monotherapy or in combination with Libtayo® (cemiplimab), as applicable); uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron's Products and Regeneron's Product Candidates; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as ubamatamab for the treatment of recurrent ovarian cancer and REGN5093 for the treatment of MET-altered advanced non-small cell lung cancer; safety issues resulting from the administration of Regeneron's Products (such as Libtayo) and Regeneron's Product Candidates (such as ubamatamab, REGN5093, and Regeneron's other investigational bispecific antibodies discussed or referenced in this press release) in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron's Products (such as Libtayo) from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees (including those discussed or referenced in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials or therapeutic applications; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), and Praluent® (alirocumab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended June 30, 2022. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
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SOURCE Regeneron Pharmaceuticals, Inc. | https://www.ktre.com/prnewswire/2022/09/10/novel-regeneron-bispecific-antibodies-show-encouraging-anti-tumor-activity-two-advanced-solid-tumors/ | 2022-09-10T19:02:56 | en | 0.931787 |
SHENZHEN, China, Sept. 10, 2022 /PRNewswire/ -- On September 9th, VOOPOO unveiled two new products of DRAG series, DRAG H80S and DRAG E60. As products of star series, since VOOPOO released the product preview, it has received extensive attention from global DRAG fans. Compared with the previous VOOPOO products of DRAG series, such as the most popular products DRAG X and DRAG S, DRAG H80S and DRAG E60 are more simplified in design and vaping experience.
Integrated Design, Easy to Enjoy Professional Device
From the compact appearance, air adjusting rotating gear, oil-filling hole and magnetic battery cover are all integrated into the body of two new products, which is more tactile and comfortable in grip. DRAG H80S is the most compact DRAG ever. The integrated design makes DRAG H80S 15% smaller in size. DRAG E60, with special mini shape and streamlined unibody of leather and metal.
The pod of DRAG H80S and DRAG E60 equipped with adjustable pod airflow, just rotate the pod to adjust the airflow with asymmetric air inlets. Besides, different from DRAG S and DRAG X, there is no need to pull out the pod or press the silicone plug, just unscrew the cover of mouthpiece, and fill e-liquid from the oil filling hole.
New Power Mode and Large Capacity, Lasting and Economic
Equipped with 2550mAh built-in large battery, DRAG E60 meets the needs of long-time vaping. DRAG H80S is compatible with single 18650 external battery.
The two products have the innovative ECO mode. It provides you more lasting vaping experience. Activating the ECO Mode enlarges 10% more vaping puffs, which meet the needs under low battery capacity.
When the battery capacity is 40% left, the interface will indicate the ECO Mode button. And you can choose whether to enter.
Multiple Innovations, Enhanced Vapor and Upgraded Flavor
DRAG H80S and DRAG E60 are originally designed with the airway with a basin structure, which gathers smooth and soft airflow. The basin also holds the condensate for easier cleaning.
The new PnP coil was ingeniously upgraded in structure design, in which the Dual in One Tech fastens the temperature rise and effectively atomizes every e-liquid and realizes a rich cloud and fine taste. Meanwhile, it improves the atomization efficiency by consuming less e-liquid.
DRAG H80S and DRAG E60 renew your impression on DRAG series at the first look and refresh experience in vaping!
WARNING: This product may be used with e-liquid products containing nicotine. Nicotine is an addictive chemical.
About VOOPOO
VOOPOO was established in 2017 and has rapidly risen through DRAG products, which have been widely acclaimed globally in a short period of time. As a high-tech enterprise with R&D, design, manufacturing, and branding, VOOPOO has four major product series — ARGUS, DRAG, VINCI, and V. Currently, VOOPOO has a presence in more than 70 countries in North America, Europe, and Asia.
Website: https://www.voopoo.com/
Instagram: https://www.instagram.com/voopootech_official/
Facebook: https://www.facebook.com/voopooglobal
YouTube: https://www.youtube.com/c/VOOPOO
Tiktok: https://www.tiktok.com/@voopoofans
Shop: https://shop.voopoo.com/
CONTACT: [email protected]
SOURCE VOOPOO | https://www.prnewswire.com/news-releases/new-drag-new-halo-voopoo-drag-new-products-released-301621570.html | 2022-09-10T19:03:00 | en | 0.916583 |
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NEW YORK, Sept. 10, 2022 /PRNewswire/ -- Omnicom Group Inc. (NYSE: OMC) today announced that it will present at the Goldman Sachs Communacopia & Technology Conference in San Francisco, California on Wednesday, September 14, 2022 at 7:30 a.m. Pacific Time. Live and archived webcasts will be available on the investor relations section of www.omnicomgroup.com.
Omnicom Group (www.omnicomgroup.com) is a leading global marketing and corporate communications company. Omnicom's branded networks and numerous specialty firms provide advertising, strategic media planning and buying, digital and interactive marketing, direct and promotional marketing, public relations and other specialty communications services to over 5,000 clients in more than 70 countries.
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SOURCE Omnicom Group Inc. | https://www.ktre.com/prnewswire/2022/09/10/omnicom-present-goldman-sachs-communacopia-conference/ | 2022-09-10T19:03:03 | en | 0.885789 |
Nearly 80 Korean War Veterans to Attend Reception that Honors Veterans of the
Battle of Chosin Reservoir and are known as 'The Chosin Few'
ARLINGTON, Va., Sept. 10, 2022 /PRNewswire/ -- StarKist Co., which is headquartered in Reston, VA, and its parent company, Dongwon of Seoul, South Korea, was proud to sponsor a luncheon today for more than 80 Korean War veterans. The luncheon was conducted as part of the National Chosin Few Reunion, which is being held at the Hilton Crystal City at the Washington Reagan National Airport, September 7-11, 2022.
"The Korean War veterans are American heroes and StarKist is honored to be a part of The Chosin Few Reunion," said Andrew Choe, StarKist President and CEO. "The Korean War veterans who fought in the battle of the Chosin Reservoir in November and December 1950, fought valiantly to protect and preserve freedom for the United States and South Korea. It is an honor to demonstrate our appreciation for their service and sacrifice."
StarKist's support for the region's Korean War veterans started when the company held an annual luncheon for the Korean War veterans of Southwestern Pennsylvania more than 10 years ago. In April 2022, the company moved to Reston, VA, and is continuing its work to recognize and thank Korean War veterans.
"It's wonderful that after all of these years the Korean community both locally and internationally have rallied around The Chosin Few to help us commemorate the battle of the Chosin Reservoir," said Colonel Warren H. Wiedhahn, USMC (Ret) and The Chosin Few Chairman/CEO. "It means so much for us that our sacrifices and service during the Korean War are appreciated. We are thankful for StarKist and Dongwon for their support and involvement."
About StarKist Co.
StarKist Co. is a socially responsible company that empowers people to live a healthy lifestyle by providing convenient proteins. An industry innovator, StarKist was the first brand to introduce single-serve pouch products, which include StarKist Tuna Creations®, Salmon Creations® and Chicken Creations®. As America's favorite tuna, StarKist represents a tradition of quality, consumer trust and a commitment to sustainability. StarKist's charismatic brand icon, Charlie® the Tuna, swam into the hearts of tuna fans in 1961 and is still a fan favorite today. StarKist Co. is a direct wholly owned subsidiary of Dongwon Industries Co., Ltd.
Michelle Faist
StarKist Corporate Affairs
[email protected]
Phone: 571-441-8096
SOURCE StarKist Co. | https://www.prnewswire.com/news-releases/starkist-co-honors-korean-war-veterans-301621571.html | 2022-09-10T19:03:06 | en | 0.957962 |
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BEIJING, Sept. 10, 2022 /PRNewswire/ -- Quhuo Limited (NASDAQ: QH) ("Quhuo," the "Company," "we" or "our"), a leading tech-enabled workforce operational solution platform in China, today announced that it filed its annual report on Form 20-F for the fiscal year ended December 31, 2021 with the Securities and Exchange Commission (the "SEC") on September 9, 2022.
The annual report, which contains the Company's audited consolidated financial statements, can be accessed on the Company's investor relations website at https://ir.quhuo.cn/ or the SEC's website at www.sec.gov. The Company will provide a hard copy of the annual report, free of charge, to its shareholders and American Depositary Share holders upon request.
The Company recorded total revenues of RMB4,025.3 million (US$631.7million), representing a 56.0% year-over-year increase, primarily due to the rapid growth of our major business lines.
- Revenues from on-demand delivery solutions were RMB3,829.0 million (US$600.8 million), representing a 50.9% year-over-year increase, primarily due to the increase in the number of delivery orders we fulfilled as a result of industry growth and our continued penetration and expansion into new geographical markets.
- Revenues from mobility service solutions were RMB110.2 million (US$17.3 million), representing a 248.7% year-over-year increase, primarily due to (1) the enlarged customer base and service scope of shared-bike maintenance solutions and (2) the commencement of freight service solutions in July 2021.
- Revenues from housekeeping and other services were RMB79.7 million (US$12.5 million), representing a 542.8% year-over-year increase, primarily due to the enlarged customer base of our housekeeping solutions and the inclusion into our solution offering of hotels and B&Bs following our acquisition of Lailai and Chengtu Home.
About Quhuo
Quhuo Limited (NASDAQ: QH) ("Quhuo" or the "Company") is a leading workforce operational solutions platform in China. Quhuo provides tech-enabled, end-to-end operational solutions to blue-chip on-demand consumer service businesses in industries with significant e-commerce exposure, primarily including on-demand food delivery, mobility services, housekeeping and accommodation. Quhuo's platform helps its industry customers mobilize a large team of workers and utilizes a combination of training, performance monitoring and refinement, and incentives to transform them into skilled workers who can follow industry-specific, standardized and highly efficient service procedures. Within the on-demand consumer service ecosystem, the Company plays a unique and indispensable role as the link between consumer service businesses and end consumers to enable the delivery of goods, services and experiences to consumers.
Safe Harbor Statements
This press release contains ''forward-looking statements'' within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding Quhuo's business development, financial outlook, beliefs and expectations. Forward-looking statements include statements containing words such as "expect," "anticipate," "believe," "project," "will" and similar expressions intended to identify forward-looking statements. These forward-looking statements are based on Quhuo's current expectations and involve risks and uncertainties. Quhuo's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties related to Quhuo's abilities to (1) manage its growth and expand its operations, (2) address any or all of the risks and challenges in the future in light of its limited operating history and evolving business portfolios, (3) remain in its competitive position in the on-demand food delivery market or further diversify its solution offerings and customer portfolio, (4) maintain relationships with major customers and to find replacement customers on commercially desirable terms or in a timely manner or at all, (5) maintain relationships with existing industry customers or attract new customers, (6) attract, retain and manage workers on its platform, and (7) maintain its market shares in relation to competitors in existing markets and its success in expansion into new markets, as well as the length and severity of the recent COVID-19 outbreak and its impact on Quhuo's business and industry. Other risks and uncertainties are included under the caption "Risk Factors" and elsewhere in the Company's filings with the Securities and Exchange Commission, including, without limitation, the final prospectus related to the IPO filed with the SEC on July 10, 2020 and the Company's latest annual report on Form 20-F. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and Quhuo undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Media Contact
Quhuo Limited
E-mail: pr@meishisong.cn
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NEW YORK, Sept. 9, 2022 /PRNewswire/ --
WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Coinbase Global, Inc. (NASDAQ: COIN) between April 14, 2021 and July 26, 2022, both dates inclusive (the "Class Period"), of the important October 3, 2022 lead plaintiff deadline.
SO WHAT: If you purchased Coinbase securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.
WHAT TO DO NEXT: To join the Coinbase class action, go to https://rosenlegal.com/submit-form/?case_id=8095 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than October 3, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.
DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Coinbase custodially held crypto assets on behalf of its customers, which assets Coinbase knew or recklessly disregarded could qualify as the property of a bankruptcy estate, making those assets potentially subject to bankruptcy proceedings in which Coinbase's customers would be treated as the Company's general unsecured creditors; (2) Coinbase allowed Americans to trade digital assets that Coinbase knew or recklessly disregarded should have been registered as securities with the SEC; (3) the foregoing conduct subjected Coinbase to a heightened risk of regulatory and governmental scrutiny and enforcement action; and (4) as a result, defendants' public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
To join the Coinbase class action, go to https://rosenlegal.com/submit-form/?case_id=8095 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com
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SOURCE Rosen Law Firm, P.A. | https://www.ktre.com/prnewswire/2022/09/10/rosen-highly-recognized-law-firm-encourages-coinbase-global-inc-investors-secure-counsel-before-important-deadline-securities-class-action-coin/ | 2022-09-10T19:03:16 | en | 0.921613 |
You need to enable JavaScript to run this app. | https://sportspyder.com/nfl/las-vegas-raiders/articles/40708871 | 2022-09-10T19:03:20 | en | 0.738227 |
NEW YORK, Sept. 10, 2022 /PRNewswire/ -- WHY: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of the securities of TuSimple Holdings Inc. (NASDAQ: TSP): (i) pursuant and/or traceable to the offering documents issued in connection with the Company's initial public offering conducted on or about April 15, 2021 (the "IPO"); and/or (ii) between April 15, 2021 and August 1, 2022, both dates inclusive (the "Class Period"). If you wish to serve as lead plaintiff, you must move the Court no later than October 31, 2022.
SO WHAT: If you purchased TuSimple securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.
WHAT TO DO NEXT: To join the TuSimple class action, go to https://rosenlegal.com/submit-form/?case_id=8026 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than October 31, 2022. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.
DETAILS OF THE CASE: According to the lawsuit, the IPO documents were negligently prepared and, as a result, contained untrue statements of material fact or omitted to state other facts necessary to make the statements made not misleading and were not prepared in accordance with the rules and regulations governing their preparation. Additionally, the complaint alleges that, throughout the Class Period, defendants made materially false and misleading statements regarding TuSimple's business, operations, and prospects. Specifically, the IPO documents and defendants made false and/or misleading statements and/or failed to disclose that: (1) TuSimple's commitment to safety was significantly overstated and defendants concealed fundamental problems with the Company's technology; (2) TuSimple was rushing the testing of its autonomous driving technology in order to deliver driverless trucks to the market ahead of its more safety-conscious competitors; (3) there was a corporate culture within TuSimple that suppressed or ignored safety concerns in favor of unrealistically ambitious testing and delivery schedules; (4) the aforementioned conduct made accidents involving TuSimple's autonomous driving technology more likely; (5) the aforementioned conduct invited enhanced regulatory scrutiny and investigatory action toward TuSimple; and (6) as a result, defendants' public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
To join the TuSimple class action, go to https://rosenlegal.com/submit-form/?case_id=8026 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com
View original content to download multimedia:
SOURCE Rosen Law Firm, P.A. | https://www.ktre.com/prnewswire/2022/09/10/rosen-recognized-investor-counsel-encourages-tusimple-holdings-inc-investors-with-losses-secure-counsel-before-important-deadline-securities-class-action-tsp/ | 2022-09-10T19:03:23 | en | 0.923192 |
You need to enable JavaScript to run this app. | https://sportspyder.com/mlb/miami-marlins/articles/40707823 | 2022-09-10T19:03:26 | en | 0.738227 |
You need to enable JavaScript to run this app. | https://sportspyder.com/mlb/miami-marlins/articles/40707848 | 2022-09-10T19:03:32 | en | 0.738227 |
JOHNSTOWN, Penn., Sept. 9, 2022 /PRNewswire/ -- The Sargent's Group, Inc. ("Sargent's"), a company based in Johnstown, Pennsylvania, has learned of a potential data security incident that may have involved information belonging to certain participants in health plans administered by Highmark Wholecare (formerly Gateway Health) ("Highmark"). Sargent's has notified potentially impacted individuals of the incident and has provided resources to assist them.
On April 9, 2022 Sargent's discovered unusual activity on certain of its computer systems and took steps to investigate what happened. Sargent's learned that transcripts of certain Highmark member appeals hearings may have been copied by someone without authorization during the incident. Sargent's then notified Highmark of the incident and coordinated with Highmark to collect current mailing addresses in order to notify the individuals whose information may have been involved. On August 12, 2022, Sargent's began mailing notification letters to these individuals and provided resources to help protect their information.
The information that may have been involved in the incident includes the Highmark members' names, member numbers, and medical information and statements provided during the appeal hearing. Sargent's has no evidence that any of this information has been misused. Individuals' Social Security numbers were not involved.
Sargent's takes data security extremely seriously. Sargent's has added several layers of protection in its environment to help prevent a similar event from occurring in the future and is confident that all data stored on its network is secure. Sargent's has established a toll-free call center to answer questions about the incident and to address related concerns. Call center representatives can be reached at 1-800-939-4170.
The privacy and protection of personal information is a top priority for Sargent's. Sargent's regrets any inconvenience or concern this incident may cause.
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SOURCE The Sargent’s Group, Inc. | https://www.ktre.com/prnewswire/2022/09/10/sargents-provides-notification-data-security-incident/ | 2022-09-10T19:03:31 | en | 0.961259 |
NEW YORK, Sept. 9, 2022 /PRNewswire/ -- Stagwell (NASDAQ: STGW) announced today that Chief Financial Officer Frank Lanuto will participate in a fireside chat at the upcoming 30th Annual Deutsche Bank Leveraged Finance Conference on Wednesday, September 21, 2022 at 9:20am. Lanuto will also be available for 1:1 investor meetings. For more information reach out Michaela Pewarski, VP, Investor Relations at ir@stagwellglobal.com.
Visit this page to view upcoming investor events and programming from Stagwell.
Stagwell is the challenger network built to transform marketing. We deliver scaled creative performance for the world's most ambitious brands, connecting culture-moving creativity with leading-edge technology to harmonize the art and science of marketing. Led by entrepreneurs, our 13,000+ specialists in 34+ countries are unified under a single purpose: to drive effectiveness and improve business results for their clients. Join us at www.stagwellglobal.com.
Contact:
For Media:
Sarah Arvizo
pr@stagwellglobal.com
For Investors:
Michaela Pewarski
ir@stagwellglobal.com
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SOURCE Stagwell Inc. | https://www.ktre.com/prnewswire/2022/09/10/stagwell-stgw-present-30th-annual-deutsche-bank-leveraged-finance-conference/ | 2022-09-10T19:03:39 | en | 0.865801 |
(NEXSTAR) — Depression can affect anyone in any place, though new data shows some areas of the U.S. have more incidences of the anxiety disorder.
Researchers at nursing information and education outlet CEUfast reviewed data from the Centers for Disease Control and Prevention to find the cities with the highest numbers of residents who have been been told they have any form of depression.
Top 15 most depressed cities/metros in the U.S., according to CEUfast are:
You can find the full 50-city list here and in the interactive map of the U.S. Cities with the Highest Rates of Depression below.
Based on the data, the U.S. city with the most depression is Billings, Montana. CEUFast says about 31% of residents out of a population of 181,000 have been told they’re depressed by a professional. Meanwhile, Kingsport, Tennessee, ranks second, with 30.6% of residents told they have depression.
Depression in the U.S.
The Centers for Disease Control and Prevention estimates about 4.7% of adults (ages 18 and older) deal with depression. There were about 45,979 deaths by suicide in 2020, CDC says.
If you’re experiencing symptoms or think you may be experiencing symptoms of depression, you should seek help from a medical professional. If you’re experiencing suicidal thoughts or emotional distress, you can call or visit the National Suicide and Crisis Lifeline 24 hours a day/seven days a week. | https://cw33.com/news/national/these-are-americas-most-depressed-cities-data-shows/ | 2022-09-10T19:03:41 | en | 0.933981 |
NEW ORLEANS, Sept. 9, 2022 /PRNewswire/ -- ClaimsFiler, a FREE shareholder information service, reminds investors that they have until October 25, 2022 to file lead plaintiff applications in a securities class action lawsuit against Stitch Fix, Inc. (NasdaqGS: SFIX), if they purchased the Company's shares between December 8, 2020, and March 8, 2022, inclusive (the "Class Period"). This action is pending in the United States District Court for the Northern District of California.
Stitch Fix investors should visit us at https://claimsfiler.com/cases/nasdaq-sfix-1/ or call toll-free (844) 367-9658. Lawyers at Kahn Swick & Foti, LLC are available to discuss your legal options.
Stitch Fix and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
On December 7, 2021, the Company disclosed the occurrence of "short term cannibalization" from new customers who chose to use its new direct-buy Freestyle option rather than the traditional Fix option, as well as a loss for its first quarter of 2021 and a cut to its full-year revenue projections. On this news, shares of Stitch Fix declined by $5.97 per share, or 24%, from $24.97 per share to $19.00 per share.
Then, on March 8, 2022, the Company disclosed a weak outlook for the third quarter of 2022 and a cut to its revenue guidance for the full year, as well as "friction" that had occurred due to customers visiting stitchfix.com, the primary landing page for customers interested in the Fix, being redirected to the Freestyle experience first. On this news, shares of Stitch Fix declined by $0.67 per share, or 6%, from $11.01 per share to $10.34 per share.
The case is Retail Wholesale Department Store Union Local 338 Retirement Fund v. Stitch Fix, Inc., No. 22-cv-4893.
ClaimsFiler has a single mission: to serve as the information source to help retail investors recover their share of billions of dollars from securities class action settlements. At ClaimsFiler.com, investors can: (1) register for free to gain access to information and settlement websites for various securities class action cases so they can timely submit their own claims; (2) upload their portfolio transactional data to be notified about relevant securities cases in which they may have a financial interest; and (3) submit inquiries to the Kahn Swick & Foti, LLC law firm for free case evaluations.
To learn more about ClaimsFiler, visit www.claimsfiler.com.
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SOURCE ClaimsFiler | https://www.ktre.com/prnewswire/2022/09/10/stitch-fix-shareholder-alert-claimsfiler-reminds-investors-with-losses-excess-100000-lead-plaintiff-deadline-class-action-lawsuit-against-stitch-fix-inc-sfix/ | 2022-09-10T19:03:45 | en | 0.943513 |
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