Biohaven Ltd. reported that its Phase 2, proof‑of‑concept study of BHV‑7000 in patients with moderate to severe major depressive disorder failed to meet the primary endpoint of reducing depressive symptoms, as measured by the Montgomery‑Åsberg Depression Rating Scale (MADRS) over six weeks, compared with placebo. The overall comparison showed no statistically significant difference between the drug and placebo, although a post‑hoc subgroup analysis hinted at a modest benefit in patients with the most severe baseline symptoms.
Safety data from the trial were reassuring. Adverse events were largely mild or moderate and occurred at rates comparable to placebo. Headache was reported in 10.7% of BHV‑7000 patients versus 9.9% of placebo patients, and nausea occurred in 4.2% versus 5.6%, respectively. No new safety signals emerged.
The result represents a significant setback for Biohaven’s psychiatric portfolio and has prompted a strategic pivot. The company is redirecting resources toward its immunology, obesity, and epilepsy programs, which are viewed as having higher potential returns. Biohaven’s cash burn has accelerated, with a negative free‑cash‑flow of $650.27 million over the last twelve months, and the company has announced a 60% reduction in annual R&D spend to extend its runway.
Investor reaction was sharp. After the announcement, the company’s shares fell between 11.8% and 17% in after‑hours trading. Analyst sentiment hardened, with UBS downgrading Biohaven to “Neutral” from “Buy” and slashing its price target to $11, while HC Wainwright & Co. cut its target from $30 to $11. The market’s negative response reflects concerns about the company’s declining pipeline success rate and the shift away from a historically high‑profile therapeutic area.
Management emphasized the broader context of the failure. Ahmed Tahseen, MD and Development Lead for Depression, said, “Although the results 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.” The statement underscores the company’s willingness to move on from this indication while maintaining a focus on scientific progress.
Looking ahead, Biohaven plans to present data from its ongoing epilepsy trials at the J.P. Morgan Healthcare Conference in January 2026. The company’s future prospects will hinge on the success of these prioritized programs and the effectiveness of its cost‑optimization strategy.
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