FDA Pauses Enrollment in Biohaven's Epilepsy Drug Trials, Shares Drop 13%
BHVN sits 73% above its 52-week low of $7.48.
Summary
The FDA imposed a partial clinical hold on Biohaven's BHV-7000 epilepsy program, pausing new patient enrollment after a rodent study identified a metabolite with uncertain human risk. The hold was issued September 4 and disclosed today, sending shares down more than 13% premarket. Over 600 patients already on treatment can continue, and one fully enrolled late-stage trial remains on track for H2 2026 results. The company says the finding may be rodent-specific and expects further animal data in coming weeks. This directly threatens the lead asset and the pending SK Biopharmaceuticals licensing deal, which has not closed and is subject to antitrust review.
At the time of this announcement, BHVN was trading at $12.95 on NYSE in the Life Sciences sector, with a market capitalization of approximately $2.3B. The 52-week trading range was $7.48 to $18.57. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Reuters.