Belite Bio's NDA for Tinlarebant in Stargardt Disease Type 1 Accepted with Priority Review by FDA

The U.S. Food and Drug Administration (FDA) has accepted Belite Bio's New Drug Application (NDA) for tinlarebant, a treatment for Stargardt disease type 1 (STGD1), granting it Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is set for February 12, 2027.