Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1
Belite Bio completed the rolling submission of its New Drug Application (NDA) to the FDA for tinlarebant, an oral therapy for Stargardt disease type 1. The submission was initiated in April 2026 under Breakthrough Therapy Designation and is now subject to a 60-day FDA review period, after which a PDUFA target action date will be assigned if accepted.
Key figures
- Drug Name
- tinlarebant
- Us patient population
- 53,000
- Fda review period days
- 60
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