H.C. Wainwright reiterated a Buy rating on Vanda Pharmaceuticals with a price target of $21. The rating follows a Federal Register notice regarding Vanda's pursuit of FDA approval for HETLIOZ as a jet lag treatment. The FDA initially declined approval, but granted Vanda a formal evidentiary hearing—the first such hearing for any drug in over 40 years. A pre-hearing conference is set for July 20, 2026, with the actual hearing expected before year-end. The analyst noted that securing the jet lag indication could allow Vanda to generate branded prescription sales largely insulated from generic competition, despite existing generic tasimelteon on the market.
Vanda Pharmaceuticals IncFDA granted a formal evidentiary hearing for HETLIOZ as jet lag treatment, a rare regulatory step that could lead to approval and insulated branded sales.