Palvella Completes FDA Rolling NDA Submission for QTORIN™ Rapamycin

Palvella Therapeutics announced on August 31, 2026, that it completed its rolling New Drug Application (NDA) submission to the FDA for QTORIN™ 3.9% rapamycin anhydrous gel to treat microcystic lymphatic malformations (microcystic LMs).

The company said the NDA is supported by results from the Phase 3 SELVA study, which met its primary, prespecified key secondary, and all four secondary efficacy endpoints; all six endpoints were statistically significant (p<0.001).

FDA is expected to decide within 60 days whether the application is complete and acceptable for filing and whether to grant Priority Review. If granted, Priority Review carries a six-month review goal.

QTORIN™ rapamycin could become the first FDA-approved therapy for microcystic LMs, a rare, chronic genetic disease affecting an estimated more than 30,000 pediatric and adult patients in the United States.

Palvella is preparing for a potential standalone U.S. launch in the first half of 2027, subject to FDA approval. The product remains investigational and is not yet approved by the FDA or any other regulatory agency.