Palvella Therapeutics completes enrollment in Phase 3 SELVA trial

Palvella Therapeutics (PVLA) announced the successful completion of SELVA, a Phase 3 trial of QTORIN 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations. The Phase 3 trial enrolled 51 subjects, exceeding the original target of 40 subjects by over 25%. SELVA is a 24-week, Phase 3, single-arm, baseline-controlled trial evaluating once-daily QTORIN rapamycin in individuals aged three years and older with microcystic LMs. Initially designed to enroll 40 subjects, the trial surpassed its enrollment target, enrolling 51 subjects at leading U.S. vascular anomaly centers. Following an 8-week baseline period and 24-week evaluation, eligible participants may continue treatment in an open-label extension study. The open-label extension study also remains open to enrolling new subjects aged three to five years who meet the study’s inclusion criteria. Top-line results from SELVA are expected in the first quarter of 2026, with a New Drug Application submission planned for the second half of 2026.