Stargardt disease

Belite Bio (BLTE) announced that the UK’s MHRA agreed to accept a Conditional Marketing Authorization application for Tinlarebant to treat Stargardt disease, based on Phase 3 DRAGON interim analysis. The DRAGON trial enrolled 104 subjects across 11 jurisdictions. Topline final data is expected in Q4 2025, which will be submitted to MHRA for full Marketing Authorization. This regulatory milestone offers a faster route to market but depends on positive final data.