Belite Bio Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt Disease | Belite Bio, Inc.
Designation is based on the pivotal Phase 3 DRAGON trial interim analysis results demonstrating Tinlarebant’s efficacy and favorable safety profile Trial completion expected by Q4 2025 (including a three-month follow-up period) Tinlarebant has previously been granted Fast Track and Rare Pediatric
Belite Bio, Inc.
