Belite Bio赢得FDA对主要候选人的优先审查

2026-08-12 18:58

The U.S. Food and Drug Administration has accepted the marketing application for Belite Bio’s (BLTE) lead asset tinlarebant, granting the priority review for the eye disease therapy with a target action date of February 12, 2027.
The New Drug Application seeks U.S. approval of the oral therapy for Stargardt Disease Type 1, a group of rare inherited eye disorders called juvenile macular dystrophy affecting children and young adults.
The NDA is supported by data from the company’s Phase 3 DRAGON trial, which indicated that tinlarebant, compared with placebo, led to an approximately 36% decline in the growth rate of atrophic retinal lesions with a clinically meaningful and statistically significant effect.
If approved, tinlarebant is set to become the first FDA-approved treatment for STGD1, Belite Bio (BLTE) said in a statement late Tuesday.

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