Vanda rises after federal court overturns FDA order denying drug approval

Vanda Pharmaceuticals

18/08/2025 12:47

** Shares of drugmaker Vanda Pharmaceuticals VNDA.O rise 5.1% to $4.58 premarket

** Co says a federal appeals court overturned the U.S. FDA's order that denied approval of its drug Hetlioz for the treatment of jet lag disorder

** VNDA had filed a petition for review with the U.S. Court of Appeals for the D.C. Circuit after the FDA declined to commence a hearing over approval for the drug

 **  FDA in 2019 declined expanded approval, citing unclear clinical significance of some measures used in a study

** Co says the court set aside the FDA's action; says anticipates the FDA will either approve the drug or commence a hearing

** Up to last close, stock down ~9% YTD

 (Reporting by Sneha S K)

 ((Sneha.SK@thomsonreuters.com))