Clinically significant angiokeratomas represent a rare, chronic and debilitating lymphatic malformation with no FDA-approved therapies and an estimated more than 50,000 diagnosed patients in the U.S.

Phase 2 single-arm, baseline-controlled trial expected to enroll up to 15 subjects at leading vascular anomaly centers and high-volume dermatology centers in the U.S.

Topline results from the Phase 2 trial are expected in the second half of 2027

WAYNE, Pa., May 04, 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 that the first patients have been dosed in LOTU, a multicenter Phase 2 clinical trial designed to evaluate the safety and efficacy of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of clinically significant angiokeratomas.