FDA accepts Hetlioz filings for priority review as a treatment for SMS

3 August 2020

Shares of Vanda Pharmaceuticals (Nasdaq: VNDA) were up 1.34% at $10.22 by mid-morning today, after the company said that the US Food and Drug Administration has accepted for priority review Vanda's applications for Smith-Magenis syndrome (SMS).

The applications include a supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) capsules and a New Drug Application (NDA) for the liquid formulation of Hetlioz for the treatment of adults and children, respectively, with Smith-Magenis syndrome (SMS).

The FDA has set December 1, 2020 as the target date for its decision under the Prescription Drug User Fee Act (PDUFA-VI).

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