BHVN INVESTOR ALERT: Kirby McInerney LLP Notifies Biohaven Ltd. Investors of Upcoming Lead Plaintiff Deadline in Class Action Lawsuit

New York, New York--(Newsfile Corp. - July 25, 2025) - The law firm of Kirby McInerney LLP reminds investors of the September 12, 2025 deadline to seek the role of lead plaintiff in a federal securities class action filed on behalf of investors who acquired Biohaven Ltd. ("Biohaven" or the "Company") (NYSE: BHVN) securities during the period from March 24, 2023 through May 14, 2025 ("the Class Period").

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Biohaven is developing troriluzole for the treatment of spinocerebellar ataxia ("SCA"), among other conditions, as well as BHV-7000 for the treatment of bipolar disorder. In May 2022, a Phase 3 trial evaluating troriluzole's efficacy as a treatment for SCA (the "Phase 3 SCA Trial") failed to meet its primary endpoint. Nonetheless, Biohaven continued to tout troriluzole's purported viability and regulatory prospects as a treatment for SCA based on certain post-hac analyses and additional data.

In May 2023, Biohaven announced that it had submitted a New Drug Application ("NDA") with the United States Food and Drug Administration ("FDA") for troriluzole as a treatment for SCA. Likewise, in October 2023, Biohaven announced that the European Medicines Agency ("EMA") had accepted the Company's Marketing Authorization Application ("MAA") for troriluzole as a treatment for SCA.

On July 27, 2023, Biohaven issued a press release disclosing that the FDA had rejected the troriluzole NDA, refusing even to review the application because the Phase 3 SCA Trial had failed to meet its primary endpoint. On this news, Biohaven's stock price declined by $5.38 per share, or approximately 22.61%, to close at $18.42 per share on July 27, 2023.

On December 16, 2024, Biohaven announced in a press release that it had resubmitted the troriluzole NDA to the FDA, following additional purportedly positive efficacy data and "completion of a pre-NDA meeting in" the fourth quarter of 2024. On March 3, 2025, Biohaven issued another press release reporting its Q4 and full year 2024 financial results and recent business developments. The Company disclosed that recent data from a late-stage study of BHV-7000 in 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 declined by $5.12 per share, or approximately 13.77%, to close at $32.06 per share on March 3, 2025.

On April 25, 2025, multiple news reports emerged that, according to the EMA, Biohaven had withdrawn its troriluzole MAA in late March 2025. On this news, Biohaven's stock price declined by $3.56 per share, or approximately 15.21%, to close at $19.84 per share on April 25, 2025.

On May 14, 2025, Biohaven issued a press release announcing that the FDA's Division of Neurology 1 had extended the Prescription Drug User Fee Act (PDUFA) date for the New Drug Application (NDA) for troriluzole by three months to allow time for a full review of Biohaven's recent submissions responding to the FDA's information requests. The press release also stated that the Division planned to hold an advisory committee meeting to discuss the application, although no date had been scheduled. Following this news, Biohaven's stock price fell $3.84 per share, or approximately 19.53%, to close at $15.82 on May 15, 2025.

The lawsuit claims that Biohaven made false or misleading statements, or failed to disclose that: (i) it exaggerated the likelihood that troriluzole would receive regulatory approval to treat SCA, as well as the strength of the supporting data; and (ii) it also overstated the effectiveness and clinical potential of BHV-7000 as a treatment for bipolar disorder.

If you purchased or otherwise acquired Biohaven securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters without any cost to you.

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Kirby McInerney LLP is a New York-based plaintiffs' law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm's efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP's website.

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