Belite_Bio Submits Tinlarebant NDA

Belite Bio has completed the rolling submission of its New Drug Application (NDA) to the United States — Food and Drug Administration for tinlarebant, an investigational oral therapy for Stargardt disease type 1 (STGD1). STGD1 is a rare, inherited retinal disease affecting approximately 53,000 people in the United States with no approved treatments. The NDA was submitted under Breakthrough Therapy Designation, granted by the United States — Food and Drug Administration due to the high unmet medical need. Tinlarebant works by reducing vitamin A-based toxins that cause retinal disease. The application will undergo a 60-day review, and if accepted, a PDUFA target action date will be assigned. This milestone is considered pivotal for Belite Bio and offers hope for patients facing progressive vision loss.