Biohaven faces investigation after FDA clinical hold on epilepsy drug

Biohaven Ltd. is facing a new securities investigation by Levi & Korsinsky LLP following a significant drop in its share price. The company’s stock fell approximately 15% after the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on new patient enrollment for its experimental epilepsy treatment, BHV-7000 (also known as opakalim).

The FDA’s decision stems from nonclinical studies in rodents, which identified a specific metabolite. The regulator stated it currently lacks sufficient information to assess whether this metabolite poses potential risks to human subjects. While the hold prevents new patients from enrolling in certain trials, Biohaven noted that patients already enrolled in the program will continue to receive the drug.

Biohaven expects to provide additional animal study data to address the FDA’s concerns in the coming weeks. The company has indicated that the significance of the metabolite finding remains unclear and may be specific to rodents. This investigation follows a separate federal securities class action filed against the company in 2025.