Belite Bio Inc

Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases with significant unmet medical needs, including Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD), as well as specific metabolic diseases. The company's lead candidate, tinlarebant, is an oral therapy designed to reduce accumulation of bisretinoid toxins in the eye by modulating retinol binding protein 4 (RBP4). Tinlarebant has completed a Phase 3 pivotal trial (DRAGON) in STGD1 that met its primary endpoint and has an NDA under FDA Priority Review with a PDUFA date of February 12, 2027. The drug holds Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations in the U.S., with Orphan Drug designations also in Europe, Japan, and Switzerland, and Sakigake Designation in Japan. The company is also evaluating tinlarebant in a Phase 2/3 trial (DRAGON II) for STGD1 and a Phase 3 trial (PHOENIX) in GA. Belite Bio currently generates no product revenue and is pre-commercial, with launch preparations underway for a potential STGD1 approval. The company trades on NASDAQ under the ticker BLTE. Updated Aug 13, 2026