Belite Bio Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant
✨ Onyx Summary Belite Bio (NASDAQ: BLTE) said the UK MHRA will accept a Conditional Marketing Authorization application for Tinlarebant in Stargardt disease based on interim Phase 3 DRAGON results, with final topline data expected in Q4 2025 for subsequent full MAA submission. The pivotal DRAGON trial enrolled 104 adolescent patients