Belite Bio to Present Phase 3 Tinlarebant Data at Vienna Conferences; FDA PDUFA Set for February 2027

Belite Bio (BLTE) said on September 29, 2026, it will present data from its retinal disease programs at two upcoming medical conferences in Vienna, including topline Phase 3 DRAGON study results for tinlarebant in adolescent Stargardt disease. Tinlarebant is an oral therapy designed to reduce accumulation of vitamin A-derived bisretinoids linked to retinal damage in Stargardt disease. The DRAGON study met its primary endpoint. The FDA granted priority review to Belite Bio's application for tinlarebant in August 2026 and set a PDUFA date of February 12, 2027. BLTE traded at $165.45, down 0.29%.