Latest news with #Phase3SCATrial


Business Wire
4 days ago
- Business
- Business Wire
Law Offices of Frank R. Cruz Encourages Biohaven Ltd. (BHVN) Investors To Inquire About Securities Fraud Class Action
LOS ANGELES--(BUSINESS WIRE)-- The Law Offices of Frank R. Cruz 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. Law Offices of Frank R. Cruz Encourages Biohaven Ltd. (BHVN) Investors To Inquire About Securities Fraud Class Action Share IF YOU SUFFERED A LOSS ON YOUR BIOHAVEN LTD. (BHVN) INVESTMENTS, CLICK HERE TO SUBMIT A CLAIM TO POTENTIALLY RECOVER YOUR LOSSES IN THE ONGOING SECURITIES FRAUD LAWSUIT. You can also contact the Law Offices of Frank R. Cruz to discuss your legal rights by email at info@ by telephone at (310) 914-5007, 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 Then, on April 25, 2025, news reports emerged that, according to the European Medicines Agency ('EMA'), Biohaven had withdrawn its Marketing Authorization Application ('MAA') for troriluzole in late March 2025.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. Contact Us To Participate or Learn More: If you purchased Biohaven securities, wish to learn more about this action, or have any questions concerning this announcement or your rights or interests with respect to these matters, please click HERE or contact us at: Law Offices of Frank R. Cruz 2121 Avenue of the Stars, Suite 800 Telephone: 310-914-5007 Email: info@ Visit our website at: This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.


Business Wire
4 days ago
- Business
- Business Wire
Securities Fraud Investigation Into Biohaven Ltd. (BHVN) Announced – Investors Who Lost Money Urged To Contact Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm
LOS ANGELES--(BUSINESS WIRE)-- Glancy Prongay & Murray LLP, a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Biohaven Ltd. ('Biohaven' or the 'Company') (NYSE: BHVN) investors concerning the Company's possible violations of the federal securities laws. IF YOU ARE AN INVESTOR WHO LOST MONEY ON BIOHAVEN LTD. (BHVN), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS. 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 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. Whistleblower Notice Persons with non-public information regarding Biohaven should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program. Under the program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Charles H. Linehan at 310-201-9150 or 888-773-9224 or email shareholders@ About Glancy Prongay & Murray LLP Glancy Prongay & Murray LLP ('GPM') is a premier law firm representing investors and consumers in securities litigation and other complex class action litigation. GPM has been consistently ranked in the Top 50 Securities Class Action Settlements by ISS Securities Class Action Services. In 2018, GPM was ranked a top five law firm in number of securities class action settlements, and a top six law firm for total dollar size of settlements. With four offices across the country, GPM's nearly 40 attorneys have won groundbreaking rulings and recovered billions of dollars for investors and consumers in securities, antitrust, consumer, and employment class actions. GPM's lawyers have handled cases covering a wide spectrum of corporate misconduct and relating to nearly all industries and sectors. GPM's past successes have been widely covered by leading news and industry publications such as The Wall Street Journal, The Financial Times, Bloomberg Businessweek, Reuters, the Associated Press, Barron's, Investor's Business Daily, Forbes, and Money. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.


Business Wire
5 days ago
- Business
- Business Wire
Securities Fraud Investigation Into Biohaven Ltd. (BHVN) Announced – Investors Who Lost Money Urged To Contact The Law Offices of Frank R. Cruz
LOS ANGELES--(BUSINESS WIRE)-- The Law Offices of Frank R. Cruz announces an investigation of Biohaven Ltd. ('Biohaven' or the 'Company') (NYSE: BHVN) on behalf of investors concerning the Company's possible violations of federal securities laws. IF YOU ARE AN INVESTOR WHO LOST MONEY ON BIOHAVEN LTD. (BHVN), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING A CLAIM TO RECOVER YOUR LOSS. What Is The Investigation About? On July 27, 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: The Law Offices of Frank R. Cruz 2121 Avenue of the Stars, Suite 800 Century City, California 90067 Call us at: 310-914-5007 Email us at: info@ Visit our website at: Follow us for updates on Twitter at If you inquire by email, please include your mailing address, telephone number, and number of shares purchased. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.