Biohaven has announced findings from its Phase II proof-of-concept trial of BHV-7000 in adults with major depressive disorder (MDD), focusing on the reduction of depressive symptoms as measured by the Montgomery Åsberg Depression Rating Scale (MADRS) over six weeks.
The study did not achieve its primary endpoint compared with placebo.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It indicated trends favouring BHV-7000 in certain clinically relevant subgroups, particularly among participants exhibiting more severe depression at baseline on primary and secondary measures.
According to Biohaven, overall tolerability and safety were observed, with adverse events primarily mild or moderate and resolving spontaneously. Headache was reported in 10.7% of those receiving BHV-7000 and 9.9% of those given placebo, while nausea occurred in 4.2% and 5.6% of the respective groups.
A low incidence of central nervous system adverse events was noted, aligning with BHV-7000’s lack of GABA activity and previous safety data.
Biohaven is performing further analyses and intends to share the results at a forthcoming scientific conference.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataBiohaven depression development lead Ahmed Tahseen said: “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 will present updates at the J.P. Morgan Healthcare Conference in San Francisco in January 2026, including data from its extracellular degrader programmes (BHV-1300 for Graves’ disease and BHV-1400 for IgAN), the Phase IIb study with taldefgrobep alfa in obesity, oncology assets, and ongoing trials with BHV-7000 in adult focal epilepsy.
In May 2025, the company commenced a randomised Phase II/III trial of the tyrosine kinase 2 (TYK2) / Janus Kinase 1 (JAK1) inhibitor, BHV-8000, aimed at treating early Parkinson’s disease (PD).
