Biohaven Follow-Up: Stock under pressure -16.7% after hours following Phase 2 study update; study did not meet its primary endpoint; see 13:01 comment for full details
- The study did not meet its primary endpoint, a reduction of depressive symptoms as measured by change in the Montgomery Åsberg Depression Rating Scale (MADRS) over six weeks compared with placebo.
- Trends favoring BHV-7000 were observed in some clinically relevant subgroups, including participants with more severe depression at screening and baseline, on primary and secondary outcome measures.
- Overall, BHV-7000 was safe and well-tolerated with adverse events mostly mild and moderate in intensity and largely resolved spontaneously.
- The only individual adverse events occurring with an incidence above 5% were headache (10.7% and 9.9% in BHV-7000 and placebo, respectively) and nausea (4.2% and 5.6% in BHV-7000 and placebo, respectively).