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.
