Belite Bio said the U.S. Food and Drug Administration accepted its New Drug Application for tinlarebant in Stargardt Disease Type 1 and granted Priority Review, with a Prescription Drug User Fee Act target action date of February 12, 2027. The filing is backed by the Phase 3 DRAGON trial, in which tinlarebant showed a statistically significant and clinically meaningful 35.7% reduction in the growth rate of atrophic retinal lesions versus placebo, and the company also disclosed additional positive secondary endpoint data showing quantitative autofluorescence, a marker of toxic bisretinoid accumulation, diverged markedly between treatment groups by month 25. Tinlarebant-treated subjects were stable to slightly down from baseline by about 2%, while placebo patients showed an increase of about 20%. Belite Bio said commercialization preparations for STGD1 are underway and that it plans a Commercial Day in September. The company is also continuing the Phase 2/3 DRAGON II study in STGD1, which has completed enrollment with 73 subjects including 15 Japanese patients, and the Phase 3 PHOENIX trial in geographic atrophy, which has completed enrollment with 530 subjects and is expected to undergo an interim analysis. For the second quarter ended June 30, 2026, Belite Bio reported cash and cash equivalents of $279.9 million and $500.1 million in U.S. Treasury bills and notes. Quarterly research and development expense rose to $18.2 million from $11.0 million a year earlier, while selling, general and administrative expense increased to $16.7 million from $6.5 million, reflecting milestone-related royalty payments, manufacturing and consulting costs, professional fees, and team expansion. Net loss widened to $28.4 million from $16.3 million in the year-earlier quarter. If approved, tinlarebant would become the first FDA-approved treatment for STGD1, a rare inherited retinal disease linked to ABCA4 gene mutations that causes progressive, irreversible vision loss and affects an estimated 53,000 people in the U.S.