Belite Bio Initiates Rolling Submission Of New Drug Application To FDA For Tinlarebant Oral Therapy To Treat Stargardt Disease Type 1

Belite Bio, Inc (NASDAQ:BLTE) ("Belite Bio" or the "Company"), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it has initiated a rolling submission of an 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 (STGD1), a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. Tinlarebant has previously been granted Breakthrough Therapy Designation (BTD) 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.