Palvella Therapeutics (NASDAQ:PVLA) issued a comprehensive 2026 corporate update detailing significant progress across its late-stage QTORIN platform, which leverages a proprietary topical rapamycin formulation for the treatment of rare dermatological and vascular conditions.
The pivotal Phase 3 SELVA trial evaluating QTORIN rapamycin for microcystic lymphatic malformations has completed enrollment with 51 patients, exceeding the original target of 40.
Topline results are anticipated in March 2026, with a planned new drug application (NDA) submission to the U.S. Food and Drug Administration in the second half of 2026 should the data prove positive.
In the Phase 2 TOIVA study of QTORIN rapamycin in cutaneous venous malformations, positive results demonstrated a 73% improvement in lesion severity.
The company has requested a Preliminary Breakthrough Therapy Advice meeting with the FDA in the first quarter of 2026 to discuss potential expedited pathways for this indication.
Palvella also outlined plans to initiate additional Phase 2 studies and introduce a new QTORIN candidate in the second half of 2026, further expanding its pipeline targeting underserved rare skin and vascular diseases.
The company highlighted robust intellectual property protection, with composition-of-matter patents for rapamycin extending through 2038 and potential protection for pitavastatin formulations through 2046.