Biohaven, the global clinical-stage biopharmaceutical company, has announced results from its Phase 2 proof-of-concept study evaluating BHV-7000 for major depressive disorder (MDD). The trial did not meet its primary endpoint: a reduction in depressive symptoms measured by 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,” the company reported. 

BHV-7000 was generally safe and well-tolerated. Adverse events were mostly mild or moderate and resolved spontaneously. Headache was reported in 10.7% of BHV-7000 participants versus 9.9% on placebo, and nausea occurred in 4.2% versus 5.6%, respectively. A low incidence of central nervous system adverse events was observed, consistent with BHV-7000’s lack of GABA activity and prior safety data. 

“Additional analyses are ongoing and the company plans to present the results at an upcoming scientific meeting,” Biohaven said. 

Despite some promising subgroup signals, the company indicated it will not pursue further psychiatric trials. “Based upon strategic prioritization of its portfolio, [Biohaven] does not plan on additional psychiatric clinical trials to keep resources focused on key priority areas of immunology, obesity and epilepsy in 2026,” the company statement read.