On Wednesday, Biohaven Ltd. (NYSE:BHVN) reported results from a Phase 2 proof-of-concept study evaluating BHV-7000 for 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.
Overall, BHV-7000 was safe and well-tolerated, with adverse events mostly mild and moderate in intensity and largely resolved spontaneously.
Additional analyses are ongoing.
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.
Analyst Take
The Phase 2 miss is a setback but not entirely unexpected. William Blair said it approached the readout cautiously, citing persistent challenges in MDD trials, including execution risk and rising placebo response.
Analyst Myles Minter noted that prior MDD data for ezogabine and Xenon Pharmaceuticals Inc.’s (NASDAQ:XENE) azetukalner (X-NOVA) showed modest effect sizes, leaving little margin for further dilution in pivotal trials of KV7.2/7.3 potentiators.
Investors also remain divided on whether the extended-release formulation of opakalim, which showed zero somnolence in Phase 1, achieves sufficient CNS exposure, or whether the shift from immediate release reduced central activity.
William Blair said the latest data do little to ease these concerns, as no efficacy signal emerged and adverse event rates were similar between BHV-7000 and placebo.
While Biohaven did disclose signals favoring BHV-7000 treatment in a subgroup of severely depressed patients at baseline, analyst Minter cautions against overinterpretation of these data, given the low number of subjects in the analysis (n=14 and n=15 BHV-7000 and placebo participants, respectively).
William Blair looks to pivotal data for opakalim in focal onset epilepsy in the first half of 2026 as a key data point to determine if the extended-release formulation of opakalim is an active formulation.
William Blair reiterates Market Perform rating as the analyst waits to see either regulatory clarity for Vyglxia following the recent CRL or convincing placebo-controlled data from the prioritized late-stage assets to be more constructive on the name under a new R&D cost basis.
BHVN Price Action: Biohaven shares were down 15.45% at $9.14 during premarket trading on Friday, according to Benzinga Pro data.
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