FDA accepts Palvella's QTORIN rapamycin NDA with Priority Review; PDUFA date Feb 28, 2027

PALVELLA THERAPEUTICS, INC.

• FDA accepted for filing and granted Priority Review to the NDA for QTORIN 3.9% rapamycin anhydrous gel in microcystic lymphatic malformations.
• PDUFA target action date set for February 28, 2027; if approved, would be the first FDA-approved therapy for microcystic LMs (>30,000 diagnosed in U.S.).
• Phase 3 SELVA met all six prespecified endpoints (all p<0.001); 95% of participants aged 6+ completing evaluation improved on the mLM-IGA primary endpoint.
• No drug-related serious adverse events in SELVA; systemic rapamycin concentrations below 2 ng/mL at all measured timepoints.
• Palvella is preparing a standalone U.S. commercial launch in the first half of 2027; also advancing QTORIN rapamycin in venous malformations and angiokeratomas.