Vanda Pharmaceuticals

Stories

Vanda's HETLIOZ clears Phase III in delayed sleep-wake phase disorder

Awaiting FDA discussion; plans sNDA 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 Sep 30

New antipsychotic approvals expand treatment options for schizophrenia and bipolar disorder

New Capabilities

Preparing commercial launch of Bysanti in H2 2026; raised full-year 2026 revenue guidance to $240–$290 million

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