USFDAJun 12, 2026, 09:32 PM
Belite Bio Completes Rolling NDA Submission to FDA for Tinlarebant
AI Summary
Belite Bio, Inc. announced the completion of its rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for tinlarebant. This investigational, once-daily oral therapy targets Stargardt disease type 1 (STGD1), a rare inherited retinal disease affecting approximately 53,000 people in the U.S. with no approved treatments. The NDA, submitted under Breakthrough Therapy Designation, will now undergo a 60-day FDA review, with a PDUFA target action date to be assigned if accepted. The company is also preparing for commercial launch following potential approval.
Key Highlights
- Belite Bio completed rolling NDA submission to FDA for tinlarebant for Stargardt disease type 1 (STGD1).
- Tinlarebant is an investigational, once-daily oral therapy for STGD1, affecting ~53,000 people in the U.S.
- The rolling NDA was initiated in April 2026 under Breakthrough Therapy Designation (BTD).
- The completed application will undergo a 60-day FDA review period.
- Phase 3 DRAGON trial demonstrated tinlarebant significantly reduced retinal lesion growth rate.
- Tinlarebant holds BTD, Fast Track, Rare Pediatric Disease, Orphan Drug, and Sakigake designations.
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