Biohaven Misses The Mark In Depression Trial, Stock Falls

Core Insights - Biohaven Ltd. reported results from a Phase 2 proof-of-concept study for BHV-7000 targeting major depressive disorder (MDD), which did not meet its primary endpoint of reducing depressive symptoms compared to placebo [1] Study Results - The study showed trends favoring BHV-7000 in clinically relevant subgroups, particularly among participants with more severe depression at screening and baseline [2] - BHV-7000 was found to be safe and well-tolerated, with adverse events primarily mild to moderate and largely resolving spontaneously [3] Strategic Focus - The company views the subgroup analyses as hypothesis-generating but plans to prioritize resources on key areas such as immunology, obesity, and epilepsy, foregoing additional psychiatric clinical trials [4] Analyst Commentary - Analysts consider the Phase 2 miss a setback but not unexpected, citing ongoing challenges in MDD trials, including execution risk and rising placebo response [5] - Concerns remain regarding the efficacy of the extended-release formulation of opakalim, as no efficacy signal was observed and adverse event rates were similar between BHV-7000 and placebo [6] - Caution is advised against overinterpretation of favorable signals in severely depressed patients due to the small sample size in the analysis [7] Market Reaction - Following the news, Biohaven shares fell by 15.45% to $9.14 in premarket trading [8]