Biohaven Ltd. (NYSE: BHVN)

This lawsuit is for anyone who acquired securities in Biohaven Ltd. (NYSE: BHVN) from March 24, 2023 through May 14, 2025.

The lawsuit alleges that the Company and certain of its executives violated federal law. Specifically, the lawsuit alleges that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the lawsuit alleges that the Company misled investors by overstating troriluzole’s regulatory prospects as a treatment for SCA, the sufficiency of data that Biohaven submitted in support of troriluzole’s regulatory approval for this indication, and BHV-7000’s efficacy and clinical prospects as a treatment for bipolar disorder.

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, the price of the Company’s stock dropped precipitously on unusually heavy trading volume. 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, the price of the Company’s stock again dropped precipitously on unusually heavy trading volume. Then, on April 25, 2025, news reports emerged that, according to the European Medicines Agency (“EMA”), Biohaven had withdrawn its Marketing Authorization Application (“MAA”) for troriluzole in late March 2025.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, the price of the Company’s stock again dropped precipitously on unusually heavy trading volume. Finally, 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, the price of the Company’s stock again dropped precipitously on unusually heavy trading volume.

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in Biohaven Ltd. (NYSE: BHVN) from March 24, 2023 through May 14, 2025 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.