Latest news with #Phase3SCA
Business Wire
18-07-2025
- Business
- Business Wire
Law Offices of Howard G. Smith Encourages Biohaven Ltd. (BHVN) Investors To Inquire About Securities Fraud Class Action
BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Biohaven Ltd. ('Biohaven' or the 'Company') (NYSE: BHVN) securities between , inclusive (the 'Class Period'). Biohaven investors have until September 12, 2025 to file a lead plaintiff motion. IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN BIOHAVEN LTD. (BHVN), CONTACT THE LAW OFFICES OF HOWARD G. SMITH TO PARTICIPATE IN THE ONGOING SECURITIES FRAUD LAWSUIT. Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@ by telephone at (215) 638-4847 or visit our website at 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 Then, on April 25, 2025, news reports emerged that, according to the European Medicines Agency ('EMA'), Biohaven had withdrawn its Marketing Authorization Application ('MAA') for troriluzole in late March 2025.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. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Business Wire
17-07-2025
- Business
- Business Wire
Biohaven Ltd. (BHVN) Investors Who Lost Money – Contact Law Offices of Howard G. Smith About Securities Fraud Investigation
BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Biohaven Ltd. ('Biohaven' or the 'Company') (NYSE: BHVN) investors concerning the Company's possible violations of federal securities laws. IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN BIOHAVEN LTD. (BHVN), CONTACT THE LAW OFFICES OF HOWARD G. SMITH ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS. Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@ by telephone at (215) 638-4847 or visit our website at 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. Contact Us To Participate or Learn More: If you purchased Biohaven securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us: Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, Telephone: (215) 638-4847 Email: howardsmith@ Visit our website at: This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
