FDA places partial clinical hold on Biohaven BHV-7000 epilepsy trial, halting new enrollment
BHVN•FDA issues partial clinical hold on BHV-7000 program
FDA issued a partial clinical hold on Sept. 4, 2026, pausing new enrollment in the BHV-7000 program over a rodent metabolite risk question.
Already randomized patients can continue dosing across the program; more than 600 patients remain on treatment.
BHV7000-303 stays on track for second-half 2026 topline data since enrollment and randomization were completed in June 2026.
BHV7000-302 can keep dosing, but enrollment is paused pending additional nonclinical data expected in coming weeks.
