Vanda plans FDA sNDA filing for Hetlioz in delayed sleep-wake phase disorder

Bitget2026/09/29 22:46

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Vanda reported positive Phase III results for HETLIOZ (tasimelteon) in Delayed Sleep-Wake Phase Disorder.
Plans to meet FDA, file a supplemental NDA seeking a new indication for DSWPD.
Trial met primary endpoint: sleep onset shifted 37.1 minutes earlier versus placebo (p=0.022).

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vanda Pharmaceuticals Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202609291845PR_NEWS_USPR_____PH59973) on September 29, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Vanda plans FDA sNDA filing for Hetlioz in delayed sleep-wake phase disorder

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