regulatory
confidence high
sentiment negative
materiality 0.85
FDA partial clinical hold on BHV-7000 pauses new enrollment; dosing continues
Biohaven Ltd.
- FDA issued partial clinical hold letter Sept 4, 2026, pausing new patient enrollment pending nonclinical metabolite data.
- Dosing continues for >600 already randomized patients; BHV7000-303 fully enrolled, topline on track for H2 2026.
- BHV7000-302 new enrollment paused; open-label extension continues dosing; global sites voluntarily paused outside U.S.
- Over 1,200 participants dosed to date; metabolite findings may be rodent-specific and of uncertain human relevance.
- Aug 26, 2026 license agreement with SK Biopharmaceuticals for Kv7 platform incl. BHV-7000; HSR submission pending.