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

Palvella Therapeutics…has submitted the first portion of its application seeking U.S. approval of QTORIN rapamycin, a treatment for microcystic lymphatic malformations, moving the company closer to potentially commercializing the first approved therapy for the rare genetic disease. (MyChesCo) - "The clinical-stage biotechnology company said it submitted the first module of a rolling New Drug Application to the U.S. Food and Drug Administration and expects to complete the filing during the second half of 2026...the company’s Phase 3 SELVA trial demonstrated statistically significant improvements across its primary and secondary endpoints...Palvella is also preparing for a potential standalone U.S. launch in the first half of 2027, contingent on regulatory approval."

FDA filing • Launch US • Rare Diseases

Palvella Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update (GlobeNewswire) - "...'with the potential for approval and U.S. commercial launch in the first half of 2027.'...Pre-New Drug Application (NDA) meeting with the FDA granted; meeting expected in the second quarter of 2026; NDA submission remains on track for the second half of 2026...Submitted application for FDA Breakthrough Therapy Designation in the second quarter of 2026."

Breakthrough therapy • FDA filing • Launch US • Rare Diseases

New Drug Application (NDA) for QTORIN rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs) on track for planned submission in second half of 2026 (The Manila Times)

FDA filing • Rare Diseases

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