Belite Bio Initiates New Drug Application Submission
Belite Bio announced that it has initiated a rolling submission of a New Drug Application, NDA, to the U.S. Food and Drug Administration, FDA, for tinlarebant, an investigational novel oral therapy for the treatment of Stargardt disease type 1, a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. Tinlarebant has previously been granted Breakthrough Therapy Designation by the FDA for STGD1, and the FDA has previously granted Belite approval for the rolling submission of the NDA. The Company expects to complete the NDA rolling submission in the second quarter of 2026.
