Signal FDA grants priority review to Belite Bio's tinlarebant for Stargardt disease

Summary

The US FDA accepted Belite Bio's New Drug Application for tinlarebant, a treatment for Stargardt disease type 1, and granted it priority review. Stargardt disease type 1 is a rare inherited eye disorder. Tinlarebant had previously received both Breakthrough Therapy and Rare Pediatric Disease designations. The priority review designation is meant to speed up the FDA's review process for the treatment. The FDA set a target decision date of February 12, 2027. If approved, tinlarebant would become the first FDA-approved treatment specifically for Stargardt disease type 1.