Biohaven (BHVN.US) Depression Drug Midterm Trial Fails Down 16% After Market

The Zhitong Finance App learned that Biohaven (BHVN.US) said on Wednesday that its experimental depression drug failed to meet the main goals in a mid-term trial. This is the latest in a series of testing and regulatory setbacks the company has experienced this year. The company's stock price fell 16% in after-hours trading, and the cumulative decline since this year has exceeded 70%.

Previously, the company failed a clinical trial in March, and its drug troriluzole (troriluzole) to treat a rare neurodegenerative disease (spinocerebellar ataxia) was also rejected by US health regulators.

In a six-week trial on patients with severe depression, BioHaven's drug BHV-7000 showed no significant difference in reducing depressive symptoms as assessed based on changes in the Montgomery Depression Rating Scale compared to placebo.

The company sees the depression subgroup analysis as a “hypothetical exploration,” but plans to focus resources on key priority areas such as immunology, obesity, and epilepsy in 2026, and does not plan to conduct additional psychiatric clinical trials.

Leonid Timashev, a capital market analyst at the Royal Bank of Canada, said that given the limited clinical efficacy data so far, and that severe depression itself is a challenging indication with significant variability and placebo effects, the failure of this trial “is not surprising”.

The company is also testing the BHV-7000 for epilepsy, which was previously evaluated for treating bipolar disorder, but failed in a mid-to-late trial earlier this year.

Timashev said, “As the riskiest event has now passed, we believe that the company's strategic focus is refocusing on recent updates on projects that investors are more interested in and have a greater chance of success (such as epilepsy). This may limit the downside of stock prices to a certain extent.”

Last month, Biohaven said the company plans to cut annual direct R&D spending by about 60% after the US Food and Drug Administration declined to approve its drug traluzole to treat spinocerebellar ataxia, a neurodegenerative disorder affecting movement and balance.