From GlobeNewswire: 2025-05-21 03:00:00

Belite Bio, Inc. receives Breakthrough Therapy Designation from the FDA for Tinlarebant to treat Stargardt disease (STGD1) based on Phase 3 DRAGON trial results. The trial is expected to be completed by Q4 2025, with favorable safety profiles and efficacy. Tinlarebant has previously been granted other designations in the U.S., Europe, and Japan for Stargardt disease, which currently has no approved treatments. Tinlarebant aims to slow or halt the disease process by targeting the underlying pathophysiology of STGD1, offering hope for patients living with this progressive condition.



Read more at GlobeNewswire: Belite Bio Announces FDA Granting of Breakthrough Therapy