Tinlarebant (LBS-008) - (DRAGON)

August 11, 2026: Belite Bio, Inc. (NASDAQ: BLTE) said the FDA accepted its NDA for tinlarebant (LBS-008) in Stargardt Disease Type 1 (STGD1) and granted Priority Review, with a PDUFA target action date of February 12, 2027.

The filing is based on the Phase 3 DRAGON trial in adolescent and adult STGD1 patients. According to the company, tinlarebant achieved a statistically significant and clinically meaningful 35.7% reduction versus placebo in the growth rate of atrophic retinal lesions, measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging. The drug was described as generally well tolerated, with side effects consistent with its mechanism of action.

Belite Bio said tinlarebant could become the first FDA-approved treatment for STGD1 if approved. The release also notes prior U.S. designations including Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug.

Other ongoing programs mentioned: tinlarebant is being evaluated in the Phase 2/3 DRAGON II trial in adolescent and adult STGD1 patients and in the Phase 3 PHOENIX trial in geographic atrophy in advanced dry AMD.