Mihael H. Polymeropoulos

New Capabilities

Active

Vanda Pharmaceuticals' experimental anxiety drug failed its 546-patient Phase III trial, and the company has put the program on hold. VQW-765 matched placebo on a public-speaking stress test in adults with social anxiety disorder.

Updated Oct 19

New Capabilities

Leading the FDA discussion and sNDA submission for DSWPD

Vanda Pharmaceuticals said a late-stage trial of HETLIOZ (tasimelteon) shifted the timing of sleep onset 37.1 minutes earlier than placebo in adults with delayed sleep-wake phase disorder (DSWPD). The result was statistically significant (p=0.022), and 60% of treated patients advanced their sleep by at least 30 minutes, versus 15% on placebo.

Updated Oct 17

New Capabilities

As of May 2026: Leading Vanda through dual drug launches in 2026

The FDA approved Cobenfy for schizophrenia in September 2024—the first drug to treat the condition through muscarinic receptors rather than dopamine, a different approach than any approved in the previous 50 years. Bysanti (milsaperidone) followed in February 2026, cleared for both schizophrenia and bipolar I disorder. For the roughly 7 million Americans with these conditions, the treatment menu is wider than it was two years ago.

Updated May 29