Biohaven Shares Fall 17% After FDA Places Partial Hold on BHV-7000 Trials

Biohaven (BHVN) announced an FDA partial clinical hold on new patient enrollment for its BHV-7000 program due to nonclinical rodent testing. The company paused new enrollment pending additional data, but ongoing studies and dosing continue. Biohaven shares fell 14.93% to $12.76 on Thursday, according to Benzinga Pro data.

Biohaven (BHVN) shares fell 10% after the FDA placed a partial hold on its epilepsy drug trial due to concerns about a metabolite found in animal studies. The company expects additional data soon and notes that over 1,200 participants have already received the drug with a favorable safety profile. Biohaven recently licensed its Kv7 platform, including the drug, to SK Biopharmaceuticals for up to $795 million. The hold does not affect the timeline for one of the trials, with results still expecte

Biohaven's stock fell 13% after the FDA paused enrollment in pivotal trials for its epilepsy drug BHV-7000 due to rodent testing concerns. This is the second regulatory setback in a year. The company expects topline data from one trial later this year but may delay another. Biohaven believes the findings may not be relevant to human safety.

Biohaven (BHVN) halted a midstage study of its seizure drug, opakalim, after safety concerns. The FDA requires further assessment of potential human toxicity from a metabolite. This caused BHVN stock to drop, potentially benefiting rival Xenon.

Biohaven Pharmaceutical (BHVN) shares dropped 12% in pre-market trading after the FDA placed a partial clinical hold on its lead epilepsy drug, BHV-7000, requiring additional studies. The hold delays new patient enrollment but allows existing patients to continue treatment. The company also filed a Form 8-K with the SEC, adding to investor uncertainty. The S&P 500, Dow Jones, and Nasdaq showed minimal movement, indicating the selloff is company-specific.

Biohaven Ltd. (NYSE:BHVN) shares dropped 17% after pausing new patient enrollment in BHV-7000 trials due to an FDA partial clinical hold. The FDA requested additional nonclinical studies for a metabolite observed in rodent tests. Over 600 patients already enrolled continue treatment, and topline data for one trial remain on track for 2026. The company believes the findings may not be relevant to human safety.