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News
The FDA has paused new patient enrollment in trials of Biohaven's experimental epilepsy drug BHV-7000 after a concerning metabolite was identified in rodent testing. The partial clinical hold, imposed on September 4, leaves the drug's human risk unclear. Biohaven's shares dropped over 15%, though analysts say the issue may be resolved quickly given the drug's broader safety record.
The FDA has placed a partial clinical hold on Biohaven's experimental epilepsy drug BHV-7000, pausing new patient enrollment in ongoing trials after a metabolite — a byproduct of how the body processes the drug — was flagged during rodent testing. The agency cited insufficient data to evaluate the potential risk to humans, though Biohaven noted the finding may be rodent-specific and its relevance to humans remains uncertain. The company also voluntarily extended the enrollment pause to international sites.
Despite the setback, more than 600 patients already enrolled can continue receiving BHV-7000, and one fully enrolled late-stage trial remains on track to report results in the second half of 2026. Biohaven disclosed the findings to SK Biopharmaceuticals ahead of an August 26 licensing deal granting it worldwide rights to the drug — a deal that still stands pending U.S. antitrust review.
By the Numbers:
Why it matters: The hold adds uncertainty to BHV-7000's path to approval and could give rival drug azetukalner (Xenon Pharmaceuticals) a competitive edge in the refractory focal epilepsy space — a condition where patients have already failed multiple treatments and have few options left.
