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

The award follows FDA review of Palvella’s annual performance progress report, which included results from the Phase 3 SELVA trial. In February 2026, Palvella announced positive topline results from the Phase 3 SELVA trial, which met its primary endpoint, pre-specified key secondary endpoint, and all four secondary efficacy endpoints, with all six efficacy endpoints achieving statistical significance (all p<0.001). In August 2026, Palvella completed the submission of its New Drug Application (NDA) for QTORIN™ rapamycin for the treatment of microcystic LMs.

Palvella’s Phase 3 SELVA trial was one of only seven new clinical trials selected for funding from 51 applications received by the FDA Orphan Products Grants Program in fiscal year 2024 and the only Phase 3 trial awarded a grant that year. Grant applications are independently reviewed and scored for scientific and technical merit by rare disease and regulatory experts and may involve consultation with the relevant FDA review division. Since its inception, the program has funded clinical trials that have facilitated the approval of more than 85 medical products for rare diseases.