Palvella Therapeutics Secures Second Year of FDA Orphan Products Grant to Support Phase 3 SELVA Trial for Microcystic Lymphatic Malformations(Note: The grant funding is specific to Palvella Therapeutics Inc. and not multiple organizations.)

Reuters
2025.10.13 11:30
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Palvella Therapeutics Inc. has secured its second year of funding from the FDA Office of Orphan Products Development grant, amounting to up to $2.6 million over four years, to support its Phase 3 SELVA trial for QTORIN™ 3.9% rapamycin anhydrous gel aimed at treating microcystic lymphatic malformations. The SELVA trial is the only Phase 3 study funded among 51 applications in fiscal year 2024, with top-line results expected in Q1 2026 and a New Drug Application planned for the second half of 2026.