BLTE PDUFA Date: Tinlarebant Page updated November 5, 2026 · next FDA decision on the calendar · Data as of Nov 5, 2026 5:03 AM ET FDA decision (PDUFA) target Feb 12, 2027 · Belite Bio, Inc · Stargardt disease type 1 (STGD1)
Key facts FDA PDUFA target date 2027-02-12
Drug / candidate Tinlarebant
Indication Stargardt disease type 1 (STGD1)
Company Belite Bio, Inc
Market-cap tier Mid
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See every 2027 PDUFA date → All February 2027 PDUFA dates → FAQ When is the BLTE PDUFA date? The FDA PDUFA target date for BLTE (Belite Bio, Inc) is 2027-02-12 for Tinlarebant. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is BLTE's drug Tinlarebant? Tinlarebant is Belite Bio, Inc's candidate under FDA review for Stargardt disease type 1 (STGD1).
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