Biohaven Ltd. (NYSE:BHVN) shares fell 17% on Thursday morning after the company paused new patient enrolment in clinical trials of BHV-7000 following a partial clinical hold from the U.S. Food and Drug Administration.
According to a company filing, the FDA requested additional nonclinical studies concerning a specific BHV-7000 metabolite observed in rodent testing. The agency said there was insufficient information at this stage to assess the metabolite’s potential risks to human participants and issued the partial clinical hold letter on September 4, 2026.
The hold applies to new enrolment rather than existing participants. More than 600 patients already randomised across the BHV-7000 programme will continue receiving treatment.
BHV-7000 is being evaluated for refractory focal epilepsy in two pivotal Phase 2/3 trials. The BHV7000-303 study completed enrolment in June 2026 and is not affected by the enrolment restriction. Biohaven said dosing is continuing and topline results remain scheduled for the second half of 2026.
Second BHV-7000 Trial Pauses New Enrolment
The BHV7000-302 study will continue dosing existing participants but cannot enrol additional patients until further nonclinical data become available, which the company expects in the coming weeks. Biohaven also voluntarily extended the enrolment pause to sites outside the United States.
Biohaven said the relevance of the metabolite findings to humans remains uncertain and that they may be specific to rodents. According to the company’s filing, more than 1,200 participants have received BHV-7000 across the development programme to date, and the clinical safety profile has generally been safe and well tolerated.
The company also said all clinical and nonclinical information concerning the metabolite characterisation was provided to SK Biopharmaceuticals before the companies signed a licensing agreement covering the Kv7 platform on August 26, 2026.
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