U.S. Food and Drug Administration Awards Year Two Proceeds from Orphan Products Grant Supporting Palvella Therapeutics’ Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations

Core Insights - Palvella Therapeutics has received a second year of funding from the FDA's Office of Orphan Products Development, amounting to up to $2.6 million over a four-year term to support its Phase 3 SELVA trial of QTORIN™ rapamycin for treating microcystic lymphatic malformations [1][3] - The SELVA trial has exceeded its enrollment goal, with 51 subjects enrolled, and is on track to report top-line data in the first quarter of 2026, with a New Drug Application (NDA) submission planned for the second half of 2026 [2][3] Company Overview - Palvella Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare skin diseases without FDA-approved treatments [5] - The company is led by veterans in rare disease drug development and is advancing a pipeline of product candidates based on its patented QTORIN™ platform [5] Clinical Trial Details - The SELVA trial is a 24-week, single-arm, baseline-controlled study designed to evaluate QTORIN™ rapamycin, which is administered once daily [2] - Following an 8-week baseline period, eligible participants may continue treatment in an open-label extension study [2] Regulatory Designations - QTORIN™ rapamycin has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA, which may lead to seven years of orphan drug market exclusivity in the U.S. if approved [4]