Palvella Therapeutics, Inc.

Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapies for patients suffering from serious, rare skin diseases and vascular malformations that currently lack FDA-approved treatments. Founded in 2015, the company's mission is to become a leading therapeutics provider in rare genetic skin diseases, focusing on addressing significant unmet medical needs. Palvella Therapeutics is headquartered in Wayne, Pennsylvania, United States.

The company's primary product candidate is QTORIN™ 3.9% rapamycin anhydrous gel, which is being developed using its proprietary QTORIN™ platform. This platform is designed to deliver targeted topical treatments for rare genetic skin diseases by optimizing drug concentration and stability while minimizing systemic absorption. QTORIN™ rapamycin is currently in Phase 3 clinical trials for microcystic lymphatic malformations (mLM) and Phase 2 clinical trials for cutaneous venous malformations, targeting conditions driven by the overactivation of the mTOR pathway. It has received FDA Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation for microcystic LMs.

Led by Founder and CEO Wes Kaupinen, Palvella Therapeutics became a publicly listed company following its merger with Pieris Pharmaceuticals in December 2024. In May 2026, the company uplisted its common stock to the Nasdaq Global Market. Recent developments include the FDA granting Rolling Review for Palvella's QTORIN™ Rapamycin New Drug Application (NDA) for microcystic lymphatic malformations on June 22, 2026, following the completion of a Pre-NDA Meeting on June 3, 2026. In preparation for a potential U.S. launch, Palvella appointed Jennifer J. McDonough as Senior Vice President of Market Access and Patient Services in March 2026. The company maintains a strong cash position, extending into 2027, as it advances its pipeline towards potential commercialization.