Vanda Pharmaceuticals Inc. (NASDAQ: VNDA), a commercial-stage company with approved treatments in psychiatry, sleep and neurology, provided an update on October 14, 2026 on VQW-765, its investigational drug for anxiety. The company said a Phase III study in adults with social anxiety disorder did not meet its primary endpoint, and that the program is on hold while it analyzes the full dataset.

Study 3201 Design and Results

The study, known as VP-VQW-765-3201, or Study 3201, enrolled 546 adults aged 18 to 65 at approximately 30 clinical sites in the U.S. Each participant had a current diagnosis of social anxiety disorder. Participants received a single oral dose of VQW-765 or placebo and then completed the Trier Social Stress Test, which includes an interview-style presentation to a panel.

The primary endpoint measured distress among female participants during the presentation, using a 0 to 100 scale where higher scores mean more distress. Females who received VQW-765 averaged 65.6, compared with 66.0 on placebo, a difference that was not statistically significant (p = 0.8899). A key secondary endpoint covering all participants was also not met, with scores of 64.7 on VQW-765 and 63.8 on placebo (p = 0.6605).

On safety, Vanda said that, consistent with prior studies, VQW-765 was safe and well tolerated. The release did not include adverse event detail.

Phase II Findings Not Confirmed

Study 3201 was designed to confirm an earlier Phase II study, Study 2201, in which participants with a history of performance anxiety who took VQW-765 reported numerically lower stress levels during the same stress test than those on placebo. The Phase III results did not confirm those findings.

“We are disappointed that Study 3201 did not confirm the earlier Phase II findings for VQW-765 in patients with social anxiety disorder,” said Mihael H. Polymeropoulos, M.D., President, Chief Executive Officer and Chairman of the Board. “We thank the participants, investigators and site staff who made this study possible.”

VQW-765 is an alpha 7 nicotinic acetylcholine receptor partial agonist that Vanda licensed from Novartis. Under that license, Vanda is responsible for all development costs and has no milestone obligations, while Novartis is eligible for tiered royalties on any future net sales. Direct research and development costs for VQW-765 were $4.9 million in the second quarter of 2026 and $8.2 million in the first half of the year.

Vanda’s Broader Pipeline and Finances

VQW-765 was one of several late-stage readouts Vanda had scheduled for 2026. In September, the company reported positive Phase III results for HETLIOZ in Delayed Sleep-Wake Phase Disorder, with sleep onset shifting 37.1 minutes earlier versus placebo, and said it intends to submit a supplemental application. Vanda also has a December 12, 2026 PDUFA date for Quimilza (imsidolimab) in generalized pustular psoriasis, and expects Phase III results for BYSANTI in adjunctive major depressive disorder in the first half of 2027.

In the second quarter of 2026, Vanda reported total revenues of $50.5 million, led by Fanapt sales of $36.0 million, which rose 23% from a year earlier. Net loss for the quarter was $62.5 million. Cash, cash equivalents and marketable securities totaled $170.0 million as of June 30, 2026, which the company expects to fund operations through at least the end of 2027. Vanda reiterated full-year 2026 revenue guidance of $240 million to $290 million.

Strategic Investment Summary

• Primary Endpoint Missed: Vanda Pharmaceuticals (NASDAQ: VNDA) reported that its Phase III Study 3201 of VQW-765 in social anxiety disorder did not meet its primary endpoint.
• Program on Hold: The VQW-765 program is on hold pending further analysis of the full dataset.
• Safety Profile: Vanda said VQW-765 was safe and well tolerated, consistent with prior studies.
• License Terms: VQW-765 is licensed from Novartis with no milestone obligations, and its direct R&D costs were $8.2 million in the first half of 2026.
• Upcoming Catalysts: Quimilza has a December 12, 2026 PDUFA date, and HETLIOZ posted positive Phase III results in Delayed Sleep-Wake Phase Disorder in September.
• Cash Runway: Vanda held $170.0 million in cash, cash equivalents and marketable securities as of June 30, 2026, expected to fund operations through at least the end of 2027.

Find out more about the latest corporate developments and financial reports at the Vanda Pharmaceuticals investor portal.

The post Vanda Pauses VQW-765 Program After Phase III Social Anxiety Study Misses Primary Endpoint appeared first on PRISM MarketView.

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