Palvella Therapeutics Receives Initial Proceeds from FDA Orphan Products Grant to Support Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations

Core Insights - Palvella Therapeutics has received a grant from the FDA Office of Orphan Products Development to support its Phase 3 SELVA trial for QTORIN™ rapamycin, aimed at treating microcystic lymphatic malformations [2][4] - The SELVA trial is one of only seven new clinical trials selected for funding out of 51 applications in fiscal year 2024, highlighting its significance [3] - Microcystic lymphatic malformations are a rare genetic disease with no FDA-approved treatments, affecting over 30,000 patients in the U.S. [5] Company Overview - Palvella Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare genetic skin diseases [6] - The company is led by veterans in rare disease drug development and is advancing a pipeline of product candidates based on its QTORIN™ platform [6] - QTORIN™ rapamycin is currently being evaluated in the Phase 3 SELVA trial and has the potential to become the first approved therapy for microcystic lymphatic malformations [4][6] Trial Details - The SELVA trial is a 24-week, single-arm, baseline-controlled study enrolling approximately 40 subjects aged three or older [3] - Top-line results from the SELVA trial are expected in the first quarter of 2026 [1][3] Grant Information - The FDA Orphan Products Grants Program provides non-dilutive funding to advance promising therapies for rare diseases, with Palvella's grant amounting to up to $2.6 million [1][4] - The program has supported clinical research leading to the approval of over 85 products since its inception [4]