Vanda Pharmaceuticals Reports Positive Phase III Results for HETLIOZ Sleep Treatment

Key Facts

1Vanda Pharmaceuticals announced positive topline results from its pivotal Phase III study of HETLIOZ for Delayed Sleep-Wake Phase Disorder.

2The study met its primary endpoint, with sleep onset timing shifting 37.1 minutes earlier compared to the placebo group.

Vanda Pharmaceuticals announced positive topline results from its pivotal Phase III study of HETLIOZ for the treatment of Delayed Sleep-Wake Phase Disorder. According to a statement via PR Newswire, the drug met its primary endpoint by shifting sleep onset timing 37.1 minutes earlier compared to the placebo group, demonstrating a statistically significant improvement.

VNDA closed at $5.17 on September 28, 2026, after trading between a session low of $4.97 and a high of $5.17. The clinical trial, which involved 43 patients across sites in the US and Europe, showed a 60% responder rate for those treated with tasimelteon compared to 15% in the placebo group.