Rolling NDA Launch

Belite Bio Inc. (BLTE) has entered the second quarter of 2026 with a pivotal milestone: the initiation of a rolling New Drug Application (NDA) for tinlarebant, its lead oral therapy for Stargardt disease type 1 (STGD1). The rolling submission is slated for completion in Q2 2026, following the company’s Phase 3 DRAGON trial, which provided the primary data for the filing. Tinlarebant, developed as LBS‑008, reduces serum retinol‑binding protein 4 (RBP4) to limit bisretinoid accumulation, and has secured Breakthrough Therapy, Fast Track, Rare Pediatric Disease, Orphan Drug, and Japan’s Sakigake designations.