RegulatoryCompany release

FDA grants Priority Review to Palvella's rapamycin gel for microcystic lymphatic malformations

🇺🇸 Palvella Therapeutics, Inc. (PVLA) · Wed 28 Oct 2026

The US regulator has accepted Palvella's NDA for QTORIN 3.9% rapamycin anhydrous gel and set a PDUFA date of 28 February 2027.

Palvella Therapeutics announced on 28 October 2026 that the US Food and Drug Administration has accepted for filing its new drug application for QTORIN 3.9% rapamycin anhydrous gel. The product is intended to treat microcystic lymphatic malformations, and the agency granted the application Priority Review.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 28 February 2027. Under the PDUFA framework, this is the date by which the agency aims to complete its review and reach a decision on the application.

According to the company, microcystic lymphatic malformations currently have no FDA-approved therapy. The submission draws on the Phase 3 SELVA study, Phase 2 data and published literature.

QTORIN rapamycin holds Breakthrough Therapy, Fast Track and Orphan Drug designations.

What it means for your team

  • Regulatory teams tracking rare-disease filings should note the PDUFA target action date of 28 February 2027.
  • The submission combines a Phase 3 study, Phase 2 data and published literature, an example of a mixed evidence package supporting a rare-disease NDA.
  • Market-access teams may wish to watch this condition as a potential first approved therapy in an area with no FDA-approved option, according to the company.

Company's press release (SEC filing): Palvella Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Palvella Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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