Lawsuit Alert: Investors who lost money with shares of Biohaven Ltd. (NYSE: BHVN) should contact the Shareholders Foundation

An investor, who purchased shares of Biohaven Ltd. (NYSE: BHVN), filed a lawsuit over alleged violations of Federal Securities Laws by Biohaven Ltd. in connection with certain allegedly false and misleading statements.

If you purchased shares of Biohaven Ltd. (NYSE: BHVN) have certain options and for certain investors are short and strict deadlines running. Deadline: September 12, 2025. NYSE: BHVN investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

New Haven, CT based Biohaven Ltd. discovers, develops, and commercializes therapies for immunology, neuroscience, and oncology worldwide. 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.

In May 2023, Biohaven Ltd. (NYSE: BHVN) 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").

On July 27, 2023, Biohaven Ltd. (NYSE: BHVN) disclosed 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 December 16, 2024, Biohaven Ltd. (NYSE: BHVN) announced, 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 Ltd. (NYSE: BHVN) reported 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 April 25, 2025, multiple news reports emerged that, according to the EMA, Biohaven Ltd. (NYSE: BHVN) had withdrawn its troriluzole MAA in late March 2025.

Then, on May 14, 2025, Biohaven Ltd. (NYSE: BHVN) issued a press release "announcing 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."

Shares of Biohaven Ltd. (NYSE: BHVN) declined from $64.21 per share on March 08, 2024, to as low as $13.04 per share on July 16, 2025.

According to the complaint the plaintiff alleges on behalf of purchasers of Biohaven Ltd. (NYSE: BHVN) common shares between March 24, 2023 and May 14, 2025, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between March 24, 2023 and May 14, 2025, the Defendants made false and/or misleading statements and/or failed to disclose that 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, that BHV-7000's efficacy and clinical prospects as a treatment for bipolar disorder were likewise overstated, that all the foregoing, once revealed, was likely to have a significant negative impact on Biohaven's business and financial condition, and that as a result, Defendants' public statements were materially false and misleading at all relevant times.

Those who purchased shares of Biohaven Ltd. (NYSE: BHVN) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.