Biohaven Ltd. (NYSE:BHVN) on Thursday announced a partial clinical hold issued by the U.S. Food and Drug Administration (FDA) on new patient enrollment for its BHV-7000 program, while maintaining timelines for its lead pivotal study in refractory focal epilepsy.
FDA Issued Partial Hold On New Enrollment
The regulatory action stems from nonclinical rodent testing that identified a specific metabolite requiring additional study to assess human risk.
The FDA instructed the biopharmaceutical firm to pause new enrollment pending incoming nonclinical data expected within weeks.
Biohaven voluntarily extended this pause to its international clinical sites outside the U.S.
Ongoing Patient Dosing And Pivotal Study Timelines
The partial hold applies strictly to new study candidates. Over 600 previously randomized patients across the BHV-7000 program continue active dosing, including participants in the BHV7000-302 trial and the associated open-label extension study.
More than 1,200 participants have received doses of BHV-7000 to date, with clinical trials consistently demonstrating a generally safe and well-tolerated profile.
Furthermore, the company confirmed that its pivotal BHV7000-303 trial evaluating 50 mg and 75 mg doses remains fully enrolled following its June 2026 completion.
Dosing in this pivotal study proceeds uninterrupted, and Biohaven expects topline data readouts in the second half of 2026.
The clinical relevance of the rodent metabolite findings remains uncertain and may not translate to human safety concerns.
Worldwide Licensing Agreement Signed
In August, Biohaven subsidiary Biohaven executed an exclusive licensing deal with SK Biopharmaceuticals Co., Ltd.
Under the terms, SK Biopharmaceuticals secures global rights to commercialize Biohaven’s Kv7 ion channel platform.
BHVN Price Action: Biohaven shares were down 14.93% to $12.76 at the time of publication on Thursday, according to Benzinga Pro data.
Photo by Pavel Kapysh via Shutterstock
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