Biohaven Ltd.

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Then, on April 25, 2025, news reports emerged that, according to the European Medicines Agency (“EMA”), Biohaven had withdrawn its Marketing Authorization Application (“MAA”) for troriluzole in late March 2025.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