WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) announced it has received the second year of funding under its U.S. Food and Drug Administration (FDA) Office of Orphan Products Development grant, supporting the company’s ongoing Phase 3 SELVA trial of QTORIN™ 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations (microcystic LMs).
The grant provides up to $2.6 million in non-dilutive funding over four years and was renewed following the FDA’s review of Palvella’s annual progress report. The company expects to report top-line data from the SELVA trial in the first quarter of 2026, with plans to submit a New Drug Application in the second half of that year.
“We are deeply appreciative of the FDA’s continued support of our Phase 3 program, which reflects the urgency and importance of addressing the significant unmet need faced by the estimated more than 30,000 individuals in the U.S. living with microcystic lymphatic malformations,” said Jeff Martini, Ph.D., Chief Scientific Officer of Palvella. “Exceeding our enrollment goal and maintaining momentum toward top-line data in early 2026 demonstrates the strength of our clinical program and our unwavering commitment to bringing QTORIN™ rapamycin to patients who currently have no FDA-approved therapies.”
The 24-week SELVA trial is a single-arm, baseline-controlled study evaluating QTORIN™ rapamycin administered once daily. Initially designed to enroll 40 participants, the trial exceeded expectations with 51 subjects enrolled across major U.S. vascular anomaly centers. Following the evaluation period, eligible participants may continue treatment in an open-label extension study.
Palvella’s Phase 3 SELVA study was one of only seven new clinical trials selected for FDA Orphan Products Grant funding in fiscal year 2024 and the only Phase 3 trial among them. The Orphan Products Grants Program supports research into treatments for rare diseases, with each proposal independently reviewed for scientific and technical merit. Since its inception, the program has contributed to the approval of more than 85 products.
QTORIN™ rapamycin has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA. If approved, the therapy would qualify for seven years of orphan drug market exclusivity in the United States.
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