NEW YORK CITY, NY / ACCESS Newswire / July 14, 2025 / Pomerantz LLP announces that a class action lawsuit has been filed against Biohaven Ltd. ("Biohaven" or the "Company") (NYSE:BHVN) and certain officers. The class action, filed in the United States District Court for the District of Connecticut, and docketed under 25-cv-01120, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Biohaven securities between March 24, 2023 and May 14, 2025, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 sand Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are an investor who purchased or otherwise acquired Biohaven securities during the Class Period, you have until September 12, 2025 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.

[Click here for information about joining the class action]

Biohaven is a biopharmaceutical company that discovers, develops, and commercializes therapies for immunology, neuroscience, and oncology. The Company is developing, among other product candidates, troriluzole for the treatment of spinocerebellar ataxia ("SCA"), among other indications, as well as BHV-7000 for the treatment of bipolar disorder, among other indications.

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, at all relevant times, Defendants continued to consistently 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 (the "troriluzole NDA"). 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 (the "troriluzole MAA").

Throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) 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; (ii) BHV-7000's efficacy and clinical prospects as a treatment for bipolar disorder were likewise overstated; (iii) all the foregoing, once revealed, was likely to have a significant negative impact on Biohaven's business and financial condition; and (iv) as a result, Defendants' public statements were materially false and misleading at all relevant times.

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 fell $5.38 per share, or 22.61%, to close at $18.42 per share on July 27, 2023.

On December 16, 2024, Biohaven issued a press release announcing, inter alia, 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 ("Q4") of 2024.

On March 3, 2025, Biohaven issued a press release reporting its Q4 and full year 2024 financial results and recent business developments. Therein, Biohaven 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 fell $5.12 per share, or 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 fell $3.56 per share, or 15.21%, to close at $19.84 per share on April 25, 2025.

Then, on May 14, 2025, Biohaven issued a press release "announc[ing] 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." The press release further stated 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 per share, or 19.53%, to close at $15.82 per share on May 15, 2025.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.

Attorney advertising. Prior results do not guarantee similar outcomes.

SOURCE: Pomerantz LLP

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