Belite Bio announces FDA granting of breakthrough therapy designation for tinlarebant for the treatment of Stargardt disease

Belite Bio

21 May 2025 - Belite Bio today announced that the US FDA has granted breakthrough therapy designation for tinlarebant for the treatment of Stargardt disease based on the previously reported interim data from the on-going Phase 3 DRAGON trial. 

There are currently no approved treatments for Stargardt disease.

Read Belite Bio press release

Michael Wonder

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Michael Wonder