Vanda's Social Anxiety Drug Fails Phase 3, Program on Hold
VNDA is trading near its 52-week low of $4.2 (5.7% below the low).
Summary
Vanda's Phase 3 trial of VQW-765, evaluated as an on-demand treatment for acute anxiety in adults with social anxiety disorder, missed its primary endpoint, with no statistically significant difference versus placebo on the Subjective Units of Distress Scale in women. The key secondary endpoint, measuring both men and women, also failed. Vanda said the drug was safe and well tolerated, consistent with previous studies. The company has placed VQW-765 on hold pending further analysis of the full dataset. This is a major setback for a pipeline asset that was expected to confirm positive Phase 2 results. The failure comes as Vanda trades near its 52-week low and faces a deteriorating financial position, with Q2 losses widening and HETLIOZ sales down 66%. The company's cash reserves have dropped to $170M, and a new 100% tariff on drug imports looms. The trial failure removes a key growth opportunity and increases pressure on the company's remaining pipeline. Vanda shares fell 2% in premarket trading Thursday after the trial missed its primary endpoint.
Updated with a Seeking Alpha report · What changed
Updates
· Seeking Alpha — Vanda Pharmaceuticals fell 2% in premarket trading Thursday after VQW-765 failed to meet the primary endpoint in a Phase III trial.
- VQW-765 was evaluated as an on-demand treatment for acute anxiety in adults with social anxiety disorder
- Vanda said the drug was safe and well tolerated, consistent with previous studies
At the time of this announcement, VNDA was trading at $3.96 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $255.2M. The 52-week trading range was $4.20 to $9.94. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: Dow Jones Newswires.