NDA submission completed following positive Phase 3 SELVA results; potential U.S. commercial launch in the first half of 2027, if approved QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric
Brings expertise in cutaneous vascular anomalies, including microcystic lymphatic malformations, venous malformations and angiokeratomas Leader in pediatric dermatology with nearly 20 years of distinguished clinical, research, and academic experience Longstanding Palvella clinical collaborator and
WAYNE, Pa., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular malformations for which there are
QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric and adult patients living with microcystic lymphatic malformations in the U.S. FDA previously granted Breakthrough Therapy and Fast Track
WAYNE, Pa., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular malformations for which there are
First module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of 2026 Preparing for a planned standalone U.S. commercial launch of QTORIN™ rapamycin for microcystic lymphatic
Hybrid public meeting on August 5th will explore approaches to selecting and prioritizing promising FDA-approved drugs for repurposing, with the potential to accelerate patient access to effective therapies for significant unmet medical needs Dr. Martini to discuss evidence frameworks and
WAYNE, Pa., July 28, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular malformations for which there are