Business
FDA Grants Rolling Review of Palvella’s QTORIN™ Rapamycin NDA for Microcystic Lymphatic Malformations
FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted Palvella remains on track to complete the NDA submission in the second half of 2026 QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,000 individuals with microcystic lymphatic malformations in the U.S. WAYNE, Pa., June 22, 2026 (GLOBE NEWSWIRE
About this update from Palvella Therapeutics, Inc.
FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted Palvella remains on track to complete the NDA submission in the second half of 2026 QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,000 individuals with microcystic lymphatic malformations in the U.S. WAYNE, Pa., June 22, 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 no U.S. Food and Drug Administration (FDA)-approved therapies, announced today that FDA has granted rolling review for the Company’s New Drug Application (NDA) for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs). “We remain on track to complete submission of the QTORIN™ rapamycin NDA in the second half of 2026 and intend to utilize the benefits of rolling review, Breakthrough Therapy and Fast Track designations to support an efficient path toward potential approval,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella Therapeutics. “Following the positive Phase 3 SELVA results, our focus is clear: move with urgency to advance QTORIN™ rapamycin as the potential first FDA-approved therapy for patients and families affected by microcystic LMs, a serious, lifelong rare disease with no approved treatment options.” Microcystic LMs are a rare, chronically debilitating genetic disease driven by dysregulation of the PI3K/mTOR pathway. Malformed lymphatic vessels can protrude through the skin, persistently leak and bleed, and cause recurrent infections, cellulitis and hospitalization. Published natural history data demonstrate that microcystic LMs are persistent and progressive and do not spontaneously regress. Surgery, sclerotherapy and laser can be limited by recurrence and repeated procedures, while systemic PI3K/mTOR inhibitors may be constrained by chronic safety and tolerability considerations, particularly in children, and by challenges in achieving sufficient exposure in affected skin. Advances in molecular genetics have established dysregulated PI3K/mTOR ...
View stock analysis, news, and events for Palvella Therapeutics, Inc.