FDA places partial clinical hold on Biohaven's BHV-7000 epilepsy program
The hold, issued September 4, 2026, pauses new patient enrollment pending further study of a metabolite seen in rodent testing, though dosing of enrolled patients continues.
Biohaven Ltd. disclosed in an 8-K filing that the FDA instructed the company to pause new enrollment until additional clarifying nonclinical studies are completed, and issued a partial clinical hold letter on September 4, 2026 that pauses new patient enrollment pending results of additional nonclinical data regarding a specific metabolite.1 The action followed updates the company provided to regulators after nonclinical characterization work on certain BHV-7000 metabolites in rodent testing found insufficient information to assess the risk of that metabolite to human subjects at this time.1
The hold affects enrollment only. It applies to new patient enrollment only.1 Patients already randomized across the BHV-7000 program, numbering more than 600, continue to be dosed.1 Biohaven said one of its two pivotal focal epilepsy studies, BHV7000-303, is fully enrolled and randomized, with dosing continuing and topline data still expected in the second half of 2026.1 The company added that there is no impact to the BHV7000-303 timeline since enrollment and randomization were already complete before the hold.1 The other pivotal study, BHV7000-302, will keep dosing existing patients, but new enrollment is paused while the company awaits nonclinical data expected in coming weeks to clarify the metabolite's significance.1 The open-label extension study, BHV7000-201, is also continuing to dose patients, the filing said.
Biohaven said the human relevance of the rodent metabolite findings is uncertain, and the findings may be specific to rodents rather than indicative of risk in people, a question the additional nonclinical studies aim to resolve.1
Separately, the filing noted that on August 26, 2026, Biohaven Bioscience Ireland Limited, a wholly owned subsidiary of the company, signed a License Agreement with SK Biopharmaceuticals Co., Ltd. granting SKBP an exclusive, royalty-bearing, worldwide license to Biohaven's Kv7 ion channel platform, including BHV-7000 and other Kv7 compounds.1 All clinical and nonclinical data related to the metabolite findings were disclosed to SKBP before the agreement was signed.1 The companies are still completing the required Hart-Scott-Rodino antitrust filing needed to close the deal.1
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