The U.S. Food and Drug Administration has accepted the New Drug Application for Palvella Therapeutics' QTORIN™ 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations and granted it Priority Review status. The FDA has set a Prescription Drug User Fee Act target action date of February 28, 2027. The application is supported by Phase 3 SELVA study results that achieved statistical significance across all six prespecified efficacy endpoints. Palvella Therapeutics is preparing for a potential standalone U.S. commercial launch in the first half of 2027, subject to regulatory approval. The company operates as a clinical-stage biopharmaceutical firm developing novel therapies for rare skin diseases and vascular anomalies.
