Palvella Therapeutics Receives Third Year Of Grant Funding From FDA Office Of Orphan Products Development For Phase 3 SELVA Trial And Ongoing Open-Label Extension Study Of QTORIN 3.9% Rapamycin Anhydrous Gel For Treatment Of Microcystic Lymphatic Malformations

Palvella Therapeutics has received its third year of grant funding from the FDA's Office of Orphan Products Development for its Phase 3 SELVA trial and ongoing open-label extension study of QTORIN 3.9% rapamycin anhydrous gel, aimed at treating microcystic lymphatic malformations. The Phase 3 SELVA trial recently reported positive topline results, achieving all primary and secondary efficacy endpoints with statistical significance (p<0.001). This trial was one of only seven selected for funding out of 51 applications in fiscal year 2024, marking it as the only Phase 3 trial to receive a grant that year.