sirolimus topical (PTX-367) / Palvella Therapeutics - LARVOL DELTA

Phase 2 clinical studies evaluating…QTORIN rapamycin in clinically significant angiokeratomas are expected to initiate in the second half of 2026 (The Manila Times)

New P2 trial • Oncology

Phase 3 SELVA study evaluating QTORIN rapamycin 3.9% anhydrous gel (QTORIN rapamycin) for microcystic lymphatic malformations (microcystic LMs) remains on track, with topline results anticipated in March 2026; pending positive results, an NDA submission is planned for the second half of 2026 (The Manila Times) - "Following positive Phase 2 results for QTORIN rapamycin for the treatment of cutaneous venous malformations announced in December 2025, requested a Preliminary Breakthrough Therapy Designation Advice meeting with the U.S. Food and Drug Administration, anticipated in the first quarter of 2026"

FDA event • FDA filing • P3 data: top line • Rare Diseases

Palvella plans to announce the fourth target clinical indication for QTORIN rapamycin in the second half of 2026. (The Manila Times) - "Palvella plans to announce the third product candidate from the QTORIN platform in the second half of 2026."

Pipeline update • Rare Diseases

Palvella Therapeutics, Inc…said the U.S. Food and Drug Administration has granted Fast Track designation to QTORIN rapamycin for the treatment of angiokeratomas, a rare and chronic skin condition with no approved therapies. (MyChesCo) - "Palvella plans to advance QTORIN rapamycin into a Phase 2 clinical study for clinically significant angiokeratomas, with trial initiation targeted for the second half of 2026. The company expects to meet with the FDA in the first half of 2026 to discuss study design, which is expected to enroll approximately 10 to 20 patients."

Fast track • New P2 trial • Oncology