8/108 sources · 6 publishersUpdated Oct 16, 11:59 UTC
Vanda Pharmaceuticals Phase III trial of VQW‑765 fails to meet primary endpoint
Vanda Pharmaceuticals announced that its Phase III study of VQW‑765 in adults with social anxiety disorder did not achieve statistical significance on the primary endpoint of distress in female participants, nor on the key secondary endpoint in the overall population. The multicenter trial enrolled 546 patients across about 30 U.S. sites and was double‑blind, placebo‑controlled. The company has placed the VQW‑765 program on hold pending a full data analysis.
Why it matters
Shares fell about 6.2% after the announcement. Oppenheimer analysts said the miss does not alter their earnings estimates for Vanda.
Key facts
- 1The Phase III trial enrolled 546 adults aged 18‑65 with social anxiety disorder. prnewswire.com
- 2The study was conducted at approximately 30 U.S. clinical sites. prnewswire.com
- 3The primary endpoint – distress during the performance phase of the Trier Social Stress Test in female participants – was not statistically significant versus placebo. prnewswire.com
- 4The key secondary endpoint – distress in the full (male and female) population – was also not met. prnewswire.com
- 5Vanda will pause the VQW‑765 program pending further analysis of the full dataset. prnewswire.com
- 6Oppenheimer analysts described the result as a "clean miss" and said it does not change their estimates for Vanda. biospace.com
Summary written by AlphAI AI Desk from 8 of 8 sources. Not investment advice. Figures are as stated by the linked sources.