Sept 10 (Reuters) – Biohaven said on Thursday the U.S. FDA had imposed a partial clinical hold, pausing new patient enrollment in trials of its experimental epilepsy drug after rodent findings, sending its shares down more than 15% in early trading.
Here are more details:
• The U.S. Food and Drug Administration imposed the hold on September 4, citing insufficient information to assess the potential human risk from a metabolite — a substance produced when the body breaks down a drug — identified during rodent testing.
• Biohaven said the finding’s significance to humans was uncertain and it could be specific to rodents. The company also voluntarily extended the enrollment pause to sites outside the U.S.
• BHV-7000 is being developed to treat refractory focal epilepsy, in which seizures start in one area of the brain and persist despite treatment with at least two suitable anti-seizure medicines.
• More than 600 patients already assigned to treatment can continue receiving the drug, Biohaven said.
• One fully enrolled late-stage trial remains on track to report results in the second half of 2026. Enrollment in another is paused, while existing patients and those in a related extension study will continue treatment.
• RBC Capital Markets analysts said though the partial hold adds development and safety risk, these may be resolved relatively quickly given the drug’s safety record in more than 1,200 participants and additional animal data expected within weeks.
• Biohaven said it disclosed the findings to SK Biopharmaceuticals before an August 26 deal granting it worldwide rights to BHV-7000 and related drugs. The deal remains subject to a U.S. antitrust filing.
• William Blair analysts said the pause would likely delay a potential U.S. approval application and extend Xenon Pharmaceuticals’ lead with its rival experimental epilepsy drug, azetukalner.
(Reporting by Kunal Das in Bengaluru; Editing by Shreya Biswas)
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