Upcoming FDA decision · February 12, 2027
Tinlarebant PDUFA date: FDA decision expected February 12, 2027
119 days to goBELITE BIO, INC (BLTE) →
The FDA is expected to decide on Tinlarebant from BELITE BIO, INC in Stargardt Disease Type 1 by the PDUFA target action date of February 12, 2027. For Stargardt Disease Type 1. NDA filing. AI-extracted from news: Belite Bio Announces U.S. Food and Drug Administration Acceptance and Priority Review of New Drug Ap
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
February 12
Target action date
Phase 3
Stage
Verified
Date confidence
—
FDA designations
Questions about this FDA decision
- When is the PDUFA date for Tinlarebant?
- The FDA's PDUFA target action date for Tinlarebant is February 12, 2027. The FDA can act before that date, and the review can be extended.
- What is Tinlarebant being reviewed for?
- The application under FDA review covers Stargardt Disease Type 1.
- Which company is developing Tinlarebant?
- BELITE BIO, INC (BLTE).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).