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.)
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.
Palvella Therapeutics Inc. has announced it has received the second year of funding from the FDA Office of Orphan Products Development grant to support its ongoing Phase 3 SELVA trial of QTORIN™ 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations. The grant provides up to $2.6 million in non-dilutive funding over four years. Palvella’s SELVA trial is the only Phase 3 clinical trial among seven new studies selected for funding from 51 applications submitted to the FDA Orphan Products Grants Program in fiscal year 2024. Top-line results from the SELVA trial are expected in the first quarter of 2026, with a New Drug Application submission planned for the second half of 2026. The funding was awarded solely to Palvella Therapeutics Inc. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Palvella Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9544239-en) on October 13, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
