Palvella's QTORIN rapamycin NDA accepted with Priority Review; PDUFA date February 28, 2027
Palvella Therapeutics said the FDA accepted for filing and granted Priority Review to its New Drug Application for QTORIN 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations, with a Prescription Drug User Fee Act target action date of February 28, 2027. The company says the drug could be the first FDA-approved therapy for this condition and is preparing for a potential U.S. launch in the first half of 2027, but approval is not assured.
Key points
- FDA accepted the NDA and granted Priority Review for QTORIN 3.9% rapamycin anhydrous gel
- PDUFA target action date set for February 28, 2027
- Phase 3 SELVA study met all six prespecified efficacy endpoints (all p<0.001)
- Potential standalone U.S. commercial launch planned for the first half of 2027, subject to FDA approval
The filing
Written by AI on Nov 9, 2026, 8:38 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 28, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.