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PVLA PDUFA Date: QTORIN rapamycin

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET
FDA decision (PDUFA) target Feb 28, 2027 · Palvella Therapeutics, Inc. · Microcystic lymphatic malformations
Source: Palvella 8-K 2026-10-28 (EX-99.1, NDA accepted, priority review). “The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.”

Key facts

FDA PDUFA target date2027-02-28
Drug / candidateQTORIN rapamycin
IndicationMicrocystic lymphatic malformations
CompanyPalvella Therapeutics, Inc.
Market-cap tierMid

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FAQ

When is the PVLA PDUFA date?
The FDA PDUFA target date for PVLA (Palvella Therapeutics, Inc.) is 2027-02-28 for QTORIN rapamycin. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is PVLA's drug QTORIN rapamycin?
QTORIN rapamycin is Palvella Therapeutics, Inc.'s candidate under FDA review for Microcystic lymphatic malformations.