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On August 11, 2026, Belite Bio announced that the U.S. Food and Drug Administration accepted its New Drug Application…
BLTEBelite Bio, Inc
On August 11, 2026, Belite Bio announced that the U.S. Food and Drug Administration accepted its New Drug Application for tinlarebant to treat Stargardt Disease Type 1 and granted it Priority Review designation. The FDA has set a Prescription Drug User Fee Act target action date of February 12, 2027. The application was based on Phase 3 DRAGON trial results showing a statistically significant 35.7% reduction in the growth rate of atrophic retinal lesions compared to placebo. If approved, tinlarebant would be the first-ever FDA-approved treatment for this rare inherited retinal disease affecting an estimated 53,000 people in the U.S. Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases.