Shares of Biohaven Ltd. (NYSE: BHVN) experienced initial declines on Friday following the announcement that the company’s Phase 2 clinical study investigating BHV-7000 for major depressive disorder (MDD) did not meet its primary endpoint. Subsequent trading stabilized as investors digested the full implications of the trial results and the company’s strategic responses.
The trial evaluated the efficacy of BHV-7000 over a six-week treatment period, with the primary endpoint defined as a statistically significant reduction in depressive symptoms measured via the Montgomery-Åsberg Depression Rating Scale (MADRS). According to Biohaven's announcement, the study did not demonstrate a meaningful difference between BHV-7000 and placebo treatments on this measure across the overall trial population.
Within the broader study group, certain subpopulations showed trends that favored BHV-7000, particularly participants who presented with more severe depressive symptoms at screening and baseline. However, the company characterized these subgroup analyses as "hypothesis-generating," indicating these findings require further validation and are not definitive evidence of therapeutic benefit.
Beyond efficacy, Biohaven reported that BHV-7000 was well tolerated throughout the trial. Adverse events attributed to the drug were generally mild to moderate and resolved without intervention. The most frequently reported adverse effects occurring at rates above 5% were headache and nausea, with incidence rates comparable between the active treatment group and placebo. Importantly, central nervous system adverse events were infrequent, consistent with BHV-7000’s pharmacological profile that lacks activity on gamma-aminobutyric acid (GABA) receptors.
In light of the trial outcomes and the overall strategic direction of the company, Biohaven has decided not to advance BHV-7000 into further psychiatric clinical development. Instead, the company will reallocate R&D resources to focus on indications in immunology, obesity, and epilepsy during 2026. The decision reflects a prioritization of projects based on portfolio considerations and evolving therapeutic opportunities.
Biohaven has indicated that additional analyses from the depression trial data are still in progress. Findings from these detailed investigations are anticipated to be presented at a forthcoming scientific meeting, providing further insights into the study results and potential future research avenues.
Despite the setback with BHV-7000 in MDD, Biohaven’s stock showed resilience during Friday’s market session. Data from Benzinga Pro reported that at the time of writing, Biohaven shares traded slightly higher by 0.19%, closing at $10.79 per share, signaling a cautious yet steady investor response to the news.