Biohaven Shares Fall Premarket on Partial FDA Hold on BHV-7000

By Colin Kellaher

Shares of Biohaven fell sharply in premarket trading on Thursday after the biopharmaceutical company said the Food and Drug Administration placed a partial hold on the clinical program for its BHV-7000 epilepsy drug candidate.

Biohaven shares were recently down nearly 17% to $12.50 in premarket action.

Biohaven said the FDA hold is related to a metabolite of BHV-7000 observed in rodent testing and pauses new patient enrollment in studies of the drug, which is also known as opakalim.

The New Haven, Conn., company said there was insufficient information related to the metabolite to assess risks to human subjects, and that the FDA ordered the pause on new study enrollment until additional clarifying nonclinical studies are completed.

Biohaven said dosing of already randomized patients is allowed to continue across the opakalim program, adding that the partial hold has no impact on its BHV7000-303 focal epilepsy study, as enrollment and randomization was already completed. The company said it still expects topline data from the study by the end of the year.

Biohaven in late August granted SK Biopharmaceuticals an exclusive worldwide license to its Kv7 ion channel platform, which is led by opakalim, in a deal that includes up to $795 million in upfront and milestone payments.

Biohaven said it fully disclosed all clinical and nonclinical data, including those related to the metabolite, to SK prior to the licensing agreement, and that the companies continue to work on completing the required U.S. antitrust submission needed for closing.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

September 10, 2026 07:55 ET (11:55 GMT)