Belite Bio Completes Rolling NDA Submission for Tinlarebant in Stargardt Disease Type 1

On June 12, 2026, Belite Bio, Inc. announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant. Tinlarebant is an investigational, once-daily oral therapy designed to treat Stargardt disease type 1 (STGD1), a rare inherited retinal disease that currently has no approved treatments. The submission was supported by results from the Phase 3 DRAGON trial, which met its primary endpoint by significantly reducing the growth rate of retinal lesions compared to placebo. The NDA was submitted under Breakthrough Therapy Designation (BTD), which Belite Bio previously received for this indication. The FDA now enters a 60-day filing review period to determine if the application is complete and acceptable for review. If accepted, the FDA will assign a Prescription Drug User Fee Act (PDUFA) target action date. Tinlarebant is also being evaluated in a Phase 2/3 trial (DRAGON II) for STGD1 and a Phase 3 trial (PHOENIX) for geographic atrophy.