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Vanda Eyes First FDA-Approved Delayed Sleep-Wake Disorder Drug

Sep 30, 2026 · 09:10 AM ET· updated 2h ago
Vanda Eyes First FDA-Approved Delayed Sleep-Wake Disorder Drug

Vanda's Phase 3 trial of HETLIOZ for DSWPD met its primary endpoint, advancing sleep onset by 42.5 minutes. sNDA submission planned.

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Why It Matters

Vanda's sleep medicine passed its final big test and worked well. The company can now ask the FDA to approve it for a new use.

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Source: Benzinga · Read the original report at the publisher. Headline and figures shown for context; data may be delayed.

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