FDA awards Palvella third-year orphan grant funding for QTORIN rapamycin Phase 3 SELVA trial
PVLA•Palvella Therapeutics received a third year of FDA Orphan Products Development grant funding for its Phase 3 SELVA program. The funding supports the trial and an open-label extension of QTORIN 3.9% rapamycin gel for microcystic lymphatic malformations; Palvella completed its rolling NDA submission in August 2026 and is targeting a potential U.S. launch in the first half of 2027 if approved.
1. Grant supports Phase 3 program
Palvella Therapeutics received a third year of FDA Orphan Products Development grant funding for its Phase 3 SELVA program. The funding supports the SELVA trial and an open-label extension of QTORIN 3.9% rapamycin gel for microcystic lymphatic malformations.
2. NDA submission completed
Palvella completed its rolling NDA submission in August 2026 and is targeting a potential U.S. launch in the first half of 2027 if approved.
