Palvella completes FDA pre-NDA meeting, targets H2 2026 NDA for 30,000-patient therapy
PVLA•PVLA•PVLA•PVLA•Palvella Therapeutics completed its FDA pre-NDA meeting for QTORIN 3.9% rapamycin gel in microcystic lymphatic malformations, covering nonclinical, clinical pharmacology and Phase 3 SELVA data. The company remains on track to submit an NDA in the second half of 2026 aiming to treat over 30,000 U.S. patients.
Palvella held an in-person pre-NDA meeting with FDA to review nonclinical data, clinical pharmacology findings, and Phase 3 SELVA trial results, including blinded independent review and representative before-and-after photographs.
The company plans to submit an NDA in H2 2026 using an evidence package comprising Phase 3 SELVA efficacy and safety data, supportive Phase 2 results, and real-world evidence from off-label use of rapamycin.
QTORIN™ rapamycin aims to become the first FDA-approved therapy for over 30,000 U.S. patients with microcystic lymphatic malformations and has Breakthrough Therapy, Orphan Drug, and Fast Track designations.
