Belite Bio FDA Breakthrough Status for Treatment of Stargardt Disease

 

• 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 Disease Designations in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and the Pioneer Drug Designation in Japan for Stargardt disease

https://www.biospace.com/press-releases/belite-bio-announces-fda-granting-of-breakthrough-therapy-designation-for-tinlarebant-for-the-treatment-of-stargardt-disease