Belite Bio Secures FDA Breakthrough Therapy Designation for Tinlarebant in Stargardt Disease Treatment

Reuters

05/21

Belite Bio Secures FDA Breakthrough Therapy Designation for Tinlarebant in Stargardt Disease Treatment

SAN DIEGO, May 21, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its drug Tinlarebant, aimed at treating Stargardt disease (STGD1). This designation is based on interim results from the Phase 3 DRAGON trial, showcasing Tinlarebant's efficacy and safety. Notably, there are currently no approved treatments for STGD1. This grant marks a significant step forward in addressing the serious unmet needs of the Stargardt community. Trial completion is expected by Q4 2025. Belite Bio has previously received multiple designations for Tinlarebant, including Fast Track and Rare Pediatric Disease Designations in the U.S., and Orphan Drug Designation in the U.S., Europe, and Japan.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Belite Bio Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9455526-en) on May 21, 2025, and is solely responsible for the information contained therein.

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