Palvella Therapeutics Granted Sixth U.S. Patent Covering 0.1–20% Anhydrous Compositions of Rapamycin and Other mTOR Inhibitors

Core Viewpoint - Palvella Therapeutics has received a new patent for its lead product candidate QTORIN™ rapamycin, which solidifies its exclusivity in the market for treating rare genetic skin diseases [2][3]. Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare genetic skin diseases without FDA-approved treatments [5]. - The company is led by veterans in rare disease drug development and is working on a pipeline based on its patented QTORIN™ platform [5]. Product Details - QTORIN™ rapamycin is a 3.9% anhydrous gel that has been granted Breakthrough Therapy, Orphan Drug, and Fast Track Designations by the FDA for treating microcystic lymphatic malformations [4]. - The newly issued patent (No. 12,329,748) covers a wide range of claims related to QTORIN™ rapamycin and other mTOR inhibitors, emphasizing its application in treating rare dermatologic conditions [3]. Financial Support - Palvella has been awarded an FDA Orphan Products Grant, which could provide up to $2.6 million to support the ongoing SELVA Phase 3 trial of QTORIN™ rapamycin [4]. Clinical Trials - QTORIN™ rapamycin is currently being evaluated in the Phase 3 SELVA clinical trial for microcystic lymphatic malformations and the Phase 2 TOIVA clinical trial for cutaneous venous malformations [5].