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, 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 for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. STGD1 affects an estimated 53,000 people in the U.S. alone, and there are currently no approved treatment options for the disease.

The rolling NDA was initiated in April 2026 and was submitted under Breakthrough Therapy Designation (BTD), which was granted by the FDA due to the high unmet need among patients living with STGD1. The completed application will undergo the 60-day review period with the FDA, and if accepted, a Prescription Drug User Fee Act (PDUFA) target action date will be assigned.

“The completion of our NDA submission marks a pivotal moment for Belite Bio and represents an important step forward for those affected by Stargardt disease who have long faced a future of progressive vision loss without an approved treatment option,” said Dr. Tom Lin, Chairman and Chief Executive Officer of Belite Bio. “We are immensely grateful to everyone who made this milestone possible, including the patients, families, and investigators who participated in our clinical trials, and the entire Belite team. We look forward to honoring them by working with the FDA to advance tinlarebant through the regulatory review process, while continuing to focus on our commercial preparedness activities in anticipation of a timely and efficient launch following potential approval.”

“Stargardt disease places a profound burden on patients, often affecting them early in life and steadily diminishing central vision during critical years of education and independence,” said Dr. Hendrik Scholl, Chief Medical Officer of Belite Bio. “We believe that the results from the Phase 3 DRAGON trial, which demonstrated tinlarebant’s ability to significantly reduce the growth rate of retinal lesions as compared to placebo, underscore its benefit and pave the way for it to potentially become the first approved therapy for this devastating disease.”