Biohaven Ltd.

Background

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Then, on April 25, 2025, news reports emerged that, according to the European Medicines Agency (“EMA”), Biohaven had withdrawn its Marketing Authorization Application (“MAA”) for troriluzole in late March 2025.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.

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.