BELITE BIO, INC (BLTE) Form 6-K — Jun 12, 2026
Belite Bio, Inc (BLTE) announced the completion of its rolling New Drug Application (NDA) submission to the FDA for tinlarebant, an investigational oral therapy for Stargardt disease type 1 (STGD1). The submission was initiated in April 2026 under Breakthrough Therapy Designation, reflecting the high unmet medical need for this rare inherited retinal disease. The NDA is supported by data from the Phase 3 DRAGON trial, which met its primary endpoint by demonstrating tinlarebant’s ability to significantly reduce the growth rate of retinal lesions compared to placebo.
Key figures
- Patient population us
- 53,000
- Fda review period days
- 60
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