Palvella Therapeutics Granted FDA Fast Track Designation for QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Angiokeratomas

Core Insights - The FDA has granted Fast Track designation to QTORIN™ rapamycin for the treatment of angiokeratomas, highlighting its potential to address a significant unmet medical need [1][2][3] - Palvella Therapeutics plans to initiate a Phase 2 trial for QTORIN™ rapamycin in the second half of 2026, following discussions with the FDA [1][4] Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare skin diseases without FDA-approved treatments [5] - The company is developing a pipeline of product candidates based on its QTORIN™ platform, with QTORIN™ rapamycin as the lead candidate targeting microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas [5] Industry Context - Angiokeratomas are chronic skin lesions with no FDA-approved therapies, affecting an estimated 50,000 diagnosed patients in the U.S. [1][2] - The FDA's Fast Track program aims to expedite the development and review of drugs for serious conditions, facilitating earlier access for patients [3]