FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules of the NDA before the full application is submitted

FDA previously granted Breakthrough Therapy and Fast Track designations for QTORIN™ rapamycin, providing an expedited development and review pathway based on its potential to address a serious unmet medical need

Palvella remains on track to complete the NDA submission in the second half of 2026 while accelerating U.S. launch readiness for a potential standalone commercial launch of QTORIN™ rapamycin in the first half of 2027, if approved

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 29, 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, today announced that the Company has submitted the first module of its rolling New Drug Application (NDA) to the FDA seeking approval of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs). Palvella remains on track to submit the remaining modules and complete the NDA submission in the second half of 2026.