FDA Grants Priority Review to Belite Bio's New Drug Application for Tinlarebant in Stargardt Disease

The U.S. Food and Drug Administration (FDA) has accepted Belite Bio's New Drug Application (NDA) for tinlarebant, a potential treatment for Stargardt disease type 1 (STGD1), granting it Priority Review. This designation reflects the significant unmet medical need for STGD1, a degenerative retinal disease. The Prescription Drug User Fee Act (PDUFA) target action date for a decision is February 12, 2027. Additional positive secondary endpoint data from the Phase 3 DRAGON trial of tinlarebant, showing a marked divergence between treatment groups in quantitative autofluorescence (qAF), were presented at the American Society of Retina Specialists (ASRS) Annual Meeting.