08:06 AM EDT, 08/18/2025 (MT Newswires) -- Vanda Pharmaceuticals ( VNDA ) said Monday it has won a legal victory over the US Food and Drug Administration as the US Court of Appeals for the D.C. Circuit has overturned the agency's order to deny approval to the company's treatment for jet lag.

Vanda submitted a supplemental new drug application in October 2018 for Hetlioz (tasimelteon) and the FDA "substantially delayed" resolving its request for a hearing regarding the application, the company said.

A federal district court found that the FDA "violated" the requirements of the Food, Drug, and Cosmetic Act, and the court ordered the FDA to resolve Vanda's application or commence a hearing, the company said.

When the FDA issued an order refusing to approve the application, Vanda filed a petition for review with the US Court of Appeals for the D.C. Circuit, which has remanded the case back to the FDA, "where Vanda anticipates the FDA will either approve the sNDA or Vanda will receive a hearing," the company said.

Vanda Pharmaceuticals ( VNDA ) shares were up 3.2% in recent premarket activity.