Palvella Gets Initial Proceeds From FDA Orphan Products Grant

(RTTNews) - Palvella Therapeutics Inc. (PVLA), a clinical-stage biopharmaceutical company, Monday it has received the initial proceeds from a previously announced grant from the FDA Office of Orphan Products Development.

The grant supports the company's ongoing Phase 3 SELVA trial of Qtorin 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations.

Out of 51 applications received by the FDA Orphan Products Grants Program in fiscal year 2024, Palvella's Phase 3 Selva trial was one of only seven new clinical trials selected for funding—and the only Phase 3 trial awarded.

The Selva trial is a 24-week, Phase 3, single-arm, baseline-controlled clinical trial of Qtorin rapamycin administered once daily for the treatment of microcystic LMs. Approximately 40 subjects age three or older are being enrolled at leading vascular anomaly centers across the U.S. The Selva trial remains on track to report top-line results in the first quarter of 2026.

"We are honored to receive this prestigious FDA grant and the initial non-dilutive funding," said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. "There are currently no FDA-approved therapies for microcystic lymphatic malformations, a rare and chronically debilitating genetic disease. Qtorin rapamycin has the potential to become the first approved therapy—and a transformative new standard of care—for individuals living with this disease."