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Biohaven Drug Trial Misses Primary Endpoint in Depression Study

MarketDash Editorial Team
5 hours ago
Biohaven announced its Phase 2 study of BHV-7000 for major depressive disorder failed to meet its primary endpoint, prompting the company to abandon further psychiatric trials and refocus on immunology, obesity, and epilepsy programs instead.

Biohaven Ltd. (BHVN) shares traded flat Friday after the company delivered disappointing news on its depression drug candidate. The Phase 2 proof-of-concept study of BHV-7000 in major depressive disorder didn't meet its primary endpoint, and the company is pulling the plug on psychiatric research altogether.

The Trial Results

The study failed to show a statistically significant reduction in depressive symptoms compared to placebo, measured by the Montgomery Åsberg Depression Rating Scale over six weeks. That's the metric that matters for regulatory approval, and it didn't clear the bar.

There's a silver lining buried in the data: BHV-7000 showed some promising trends in certain patient subgroups, particularly those with more severe depression at the study's start. But Biohaven cautioned these are "hypothesis-generating" observations, which is scientific speak for "interesting but not conclusive."

Safety Profile Looked Good

On the positive side, BHV-7000 demonstrated a clean safety profile. Adverse events were largely mild to moderate and resolved on their own. The most common side effects were headache and nausea, both occurring at rates above 5%, with similar frequency in both treatment and placebo groups. The drug also showed low rates of central nervous system adverse events, consistent with its lack of GABA activity.

Strategic Pivot

Rather than pursuing additional psychiatric trials, Biohaven is redirecting resources toward its immunology, obesity, and epilepsy programs in 2026. The company plans to present additional analyses from the depression study at a future scientific meeting, but the psychiatric chapter appears closed for BHV-7000.

BHVN Price Action: Biohaven shares were trading 0.19% higher at $10.79 Friday afternoon.

Biohaven Drug Trial Misses Primary Endpoint in Depression Study

MarketDash Editorial Team
5 hours ago
Biohaven announced its Phase 2 study of BHV-7000 for major depressive disorder failed to meet its primary endpoint, prompting the company to abandon further psychiatric trials and refocus on immunology, obesity, and epilepsy programs instead.

Biohaven Ltd. (BHVN) shares traded flat Friday after the company delivered disappointing news on its depression drug candidate. The Phase 2 proof-of-concept study of BHV-7000 in major depressive disorder didn't meet its primary endpoint, and the company is pulling the plug on psychiatric research altogether.

The Trial Results

The study failed to show a statistically significant reduction in depressive symptoms compared to placebo, measured by the Montgomery Åsberg Depression Rating Scale over six weeks. That's the metric that matters for regulatory approval, and it didn't clear the bar.

There's a silver lining buried in the data: BHV-7000 showed some promising trends in certain patient subgroups, particularly those with more severe depression at the study's start. But Biohaven cautioned these are "hypothesis-generating" observations, which is scientific speak for "interesting but not conclusive."

Safety Profile Looked Good

On the positive side, BHV-7000 demonstrated a clean safety profile. Adverse events were largely mild to moderate and resolved on their own. The most common side effects were headache and nausea, both occurring at rates above 5%, with similar frequency in both treatment and placebo groups. The drug also showed low rates of central nervous system adverse events, consistent with its lack of GABA activity.

Strategic Pivot

Rather than pursuing additional psychiatric trials, Biohaven is redirecting resources toward its immunology, obesity, and epilepsy programs in 2026. The company plans to present additional analyses from the depression study at a future scientific meeting, but the psychiatric chapter appears closed for BHV-7000.

BHVN Price Action: Biohaven shares were trading 0.19% higher at $10.79 Friday afternoon.