Palvella Therapeutics Announces Completion of FDA Pre-NDA Meeting for QTORIN™ Rapamycin in Microcystic Lymphatic Malformations

About this update from Palvella Therapeutics, Inc.

Palvella remains on track to submit an NDA in the second half of 2026 Microcystic lymphatic malformations are serious, chronic, lifelong vascular malformations that can cause persistent leaking, bleeding, infection, functional impairment, and significant daily burden for patients and families 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 03, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced completion of its pre-New Drug Application (NDA) meeting with FDA for QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) in microcystic lymphatic malformations (microcystic LMs). The pre-NDA meeting addressed nonclinical, clinical pharmacology, and clinical information for the planned NDA and included an in-person discussion with FDA and receipt of official meeting minutes. “We are pleased with the outcome of our pre-NDA meeting with FDA and encouraged as we continue advancing toward submission of an NDA for QTORIN™ rapamycin in microcystic lymphatic malformations in the second half of 2026, in line with our previous guidance,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “At the pre-NDA meeting, investigators from our Phase 3 SELVA study with expertise in vascular malformations, including a pediatric hematologist-oncologist and pediatric dermatologist, provided perspectives on the magnitude and clinical meaningfulness of the treatment effect observed in SELVA and reviewed representative before-and-after photographs from the study. Overall, we believe the results observed with QTORIN™ rapamycin in our Phase 3 SELVA and Phase 2 studies demonstrate its potential as the first targeted therapy for microcystic lymphatic malformations, a serious, lifelong disease for which patients today have no FDA-approved therapies and rely on interventional procedures and off-label treatments that do not adequately address the chronic burden of disease.” Following ...

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