Biohaven stock tumbles after pausing trial enrollment

Investing.com -- Biohaven Ltd. (NYSE: BHVN) shares fell 17% Thursday morning after the company paused new patient enrollment in its BHV-7000 clinical trials following a partial clinical hold issued by the U.S. Food and Drug Administration.

The FDA instructed the company to halt new enrollment pending additional nonclinical studies related to a specific metabolite of BHV-7000 observed in rodent testing, according to a company filing. The agency determined there was insufficient information to assess risks of the metabolite to human subjects at this time and issued the partial clinical hold letter on September 4, 2026.

The hold applies only to new patient enrollment, while dosing continues for more than 600 patients already randomized across the BHV-7000 program. BHV-7000 is being evaluated as a treatment for refractory focal epilepsy in two pivotal Phase 2/3 trials.

One of the two pivotal studies, BHV7000-303, completed enrollment in June 2026 and remains unaffected by the partial hold. The company said dosing continues in that trial and topline data remain on track for the second half of 2026.

The second pivotal study, BHV7000-302, will continue dosing existing patients but cannot enroll new participants until additional nonclinical data are available in the coming weeks. The company also voluntarily applied the enrollment pause to global sites outside the U.S.

Biohaven stated that the significance of the nonclinical metabolite findings to humans is uncertain and that the findings may be specific to rodents and not relevant to human safety. The clinical safety profile of BHV-7000 has generally been safe and well-tolerated to date with over 1,200 participants dosed across the development program, according to the filing.

The company disclosed that all clinical and nonclinical data related to the metabolite characterization were fully shared with SK Biopharmaceuticals prior to signing a licensing agreement for the Kv7 platform on August 26, 2026.

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