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Sarepta drops another 5% to $13.37 after downgrades, FDA probe

Sarepta drops another 5% to $13.37 after downgrades, FDA probe

22:41 EDT Sarepta (SRPT) drops another 5% to $13.37 after downgrades, FDA probe
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Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm Encourages Biohaven Ltd. (BHVN) Investors To Inquire About Securities Fraud Class Action
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LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP, a leading national shareholder rights law firm, announces that a securities fraud class action lawsuit has been filed on behalf of investors who purchased or otherwise acquired Biohaven Ltd. ('Biohaven' or the 'Company') (NYSE: BHVN) securities between March 24, 2023 and May 14, 2025, inclusive (the 'Class Period'). Biohaven investors have until September 12, 2025 to file a lead plaintiff motion. IF YOU SUFFERED A LOSS ON YOUR BIOHAVEN LTD. (BHVN), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS UNDER THE FEDERAL SECURITIES LAWS What Happened? On July 17, 2023, Biohaven disclosed that the FDA had rejected the New Drug Application ('NDA') for its spinocerebellar ataxia ('SCA') treatment, troriluzole, having refused to even review the application after the Phase 3 SCA Trial had failed to meet its primary endpoint. On this news, Biohaven's stock price fell $5.38, or 22.6%, to close at $18.42 per share on July 27, 2023, thereby injuring investors. Then, on March 3, 2025, Biohaven released its fourth quarter and full year 2024 financial results, disclosing that recent data from a late-stage study of its BHV-7000 treatment for bipolar mania 'did not statistically separate from the comparator on the Young Mania Rating Scale primary outcome measure[.]' On this news, Biohaven's stock price fell $5.12, or 13.8%, to close at $32.06 per share on March 3, 2025. Then, on April 25, 2025, news reports emerged that, according to the European Medicines Agency ('EMA'), Biohaven had withdrawn its Marketing Authorization Application ('MAA') for troriluzole in late March 2025. On this news, Biohaven's stock price fell $3.56, or 15.2%, to close at $19.84 per share on April 25, 2025. Then, on May 14, 2025, Biohaven announced that 'the Division of Neurology 1 within FDA's Office of Neuroscience informed the Company that they are extending the [Prescription Drug User Fee Act ('PDUFA')] date for the troriluzole [NDA] for the treatment of [SCA] by three months to provide time for a full review of Biohaven's recent submissions related to information requests from the FDA,' and that '[t]he Division also informed Biohaven that it is currently planning to hold an advisory committee meeting to discuss the application, but no date has been scheduled.' On this news, Biohaven's stock price fell $3.84, or 19.5%, to close at $15.82 per share on May 15, 2025, thereby injuring investors further. What Is The Lawsuit About? The complaint filed in this class action alleges that 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: (1) troriluzole's regulatory prospects as a treatment for SCA, and/or the sufficiency of data that Biohaven submitted in support of troriluzole's regulatory approval for this indication, were overstated; (2) BHV-7000's efficacy and clinical prospects as a treatment for bipolar disorder were likewise overstated; (3) all the foregoing, once revealed, was likely to have a significant negative impact on Biohaven's business and financial condition; and (4) as a result, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times. If you purchased or otherwise acquired Biohaven securities during the Class Period, you may move the Court no later than September 12, 2025 to request appointment as lead plaintiff in this putative class action lawsuit. Contact Us To Participate or Learn More: If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us: Charles Linehan, Esq., Glancy Prongay & Murray LLP, 1925 Century Park East, Suite 2100, Los Angeles California 90067 Email: shareholders@ Telephone: 310-201-9150, Toll-Free: 888-773-9224 Visit our website at Follow us for updates on LinkedIn, Twitter, or Facebook. If you inquire by email, please include your mailing address, telephone number and number of shares purchased. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

FDA Appoints Biotech Executive as Top Drug Regulator Under RFK Jr.
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Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency's top drug regulator, the agency confirmed Monday. Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University, will serve as director of the Center for Drug Evaluation and Research, one of the FDA's largest and most important divisions with a staff of about 5,700 that reviews the vast majority of new drug applications. Jacqueline Corrigan-Curay, the acting head of the CDER, recently announced she was leaving the agency. Tidmarsh, 65, was involved in the development of several approved drugs, likely making him a reassuring choice for a pharmaceutical industry that's facing pressure from the Trump administration to lower prices and move manufacturing to the US. Tidmarsh's appointment 'brings in a generally well-respected, credible industry veteran, we believe helping fill a key regulatory void,' Brian Abrahams, an analyst at RBC Capital Markets, said in a note to clients. While recent cuts at the agency have raised concerns about the FDA's drug approval process, 'we would expect Tidmarsh to be a pragmatic officer who will likely build upon current practice to ensure continuity and potentially be an advocate for the industry.' Among the controversies Tidmarsh will contend with is the agency's accelerated approval process. The use of this expedited pathway to get drugs green lit has skyrocketed in recent years and been criticized for sometimes letting unproven treatments linger on the market for too long. Advocates say speeding up the process gets drugs quickly to patients suffering from serious diseases. Tidmarsh is also primed to be a key player in reassessing the agency's approach to regulating prescription drug advertising. Health Secretary Robert F. Kennedy Jr. has long been a critic of direct-to-consumer drug advertising, and Makary has indicated that the agency is reviewing its approach to regulating such ads. During a panel on censorship and scientific speech at Stanford last year, Tidmarsh raised concerns about the FDA's inconsistent regulation of pharmaceutical products. He pointed to the agency's long-standing restrictions on off-label communication by manufacturers and questioned some vaccine makers' ads during the pandemic.'This discrepancy shows that FDA may apply free speech regulation at a whim and inconsistently,' he said. While the FDA's vaccine division has been in the spotlight recently over Covid shots, the drug division has made some of the agency's most controversial decisions. In the '90s, CDER approved language allowing opioid drugs, such as OxyContin, to be widely marketed — despite a lack of substantial evidence supporting their long-term effectiveness. The move helped pave the way for the opioid epidemic. The division also caused a firestorm after approving the Alzheimer's treatment Aduhelm that hadn't clearly been proven to work in research studies. On a recent podcast, Tidmarsh said he met Makary at a conference last fall at Stanford. It featured many people critical of restrictions and mandates during the pandemic, several of whom now have top government health jobs. Tidmarsh appears to share Makary's concerns about a lack of dissenting viewpoints in science. In a podcast about a year ago, he said academics foster a culture that is reluctant to question prevailing views and that grantmaking has become concentrated into a few hands. On LinkedIn last year, Tidmarsh wrote that 'academic science has become riddled with fraud, the time has come to root out the corruption.' He funds the Sleuth in Residence program that supports scientific fraud investigators at the website Retraction Watch, which tracks academic journals. At Stanford, Tidmarsh got both his medical degree and a PhD in cancer biology and then worked in the school's clinical faculty. He also had a series of biotech jobs, including chief executive officer for La Jolla Pharmaceutical Co., which developed a drug to treat sepsis and is now part of Innoviva Inc. Tidmarsh, who was also trained in pediatric oncology, has worked over the years to find solutions to shortages of old lifesaving cancer drugs. In an interview last year with a publication for doctors, he likened the US generic drug market to a 'wild west' where predatory contracting practices can drive out manufacturers. Langreth and Hornblower write for Bloomberg.

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