Belite Bio Initiates Rolling NDA Submission for Tinlarebant for STGD1

Belite Bio has initiated a rolling New Drug Application (NDA) submission to the U.S. FDA for tinlarebant, its investigational oral therapy for Stargardt disease type 1 (STGD1). The company anticipates completing the submission in the second quarter of 2026. This significant milestone leverages tinlarebant's Breakthrough Therapy Designation and positions it as a potential first-ever approved treatment for this rare, progressive retinal disorder, impacting patients and caregivers.