Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported results from a Phase 2 proof-of-concept study evaluating BHV-7000 for the treatment of major depressive disorder (MDD). 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 (see Figures 1-3). 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).

A low incidence of central nervous system adverse events was observed, consistent with BHV-7000's lack of GABA activity and with safety data from previously reported studies. Additional analyses are ongoing and the company plans to present the results at an upcoming scientific meeting. The company considers the depression subgroup analyses as hypothesis generating but based upon strategic prioritization of its portfolio does not plan on additional psychiatric clinical trials to keep resources focused on key priority areas of immunology, obesity and epilepsy in 2026.

 

Ahmed Tahseen, MD, Development Lead for Depression at Biohaven, commented, "There is an urgent need for novel therapies for depression that require the exploration of new mechanistic approaches to this common disorder. Although the results of this study do not support the efficacy of BHV-7000 in a broad population of depressed patients, we appreciate the commitment of the patients, investigators, and study teams who have advanced the field assessing new therapeutic approaches and made this important research possible."

Biohaven management will be presenting at the annual J.P. Morgan Healthcare Conference in San Francisco in January 2026 and intends to provide extensive updates across the breadth of its clinical programs, notably including:

• clinical data for two of its extracellular degrader programs from initial patient experience in the Phase 1b expansion cohorts BHV-1400 for IgAN and BHV-1300 for Graves' disease;
• expectations for the company's recently initiated Phase 2b study with taldefgrobep alfa in obesity
• oncology clinical stage assets;
• and emerging data from its ongoing clinical trial with BHV-7000 in adult focal epilepsy