Palvella submits FDA NDA for QTORIN gel

• Palvella Therapeutics (NASDAQ:PVLA) submitted the first module of its rolling NDA to the FDA for QTORIN 3.9% rapamycin gel.
• The treatment targets microcystic lymphatic malformations, a rare condition affecting an estimated 30,000+ patients in the U.S.
• The company aims to complete the NDA in 2H 2026, with a potential U.S. launch in 1H 2027 if approved.

Palvella Therapeutics (NASDAQ:PVLA) said it has submitted the first module of a rolling New Drug Application to the U.S. Food and Drug Administration for QTORIN 3.9% rapamycin gel.

The application is for the treatment of microcystic lymphatic malformations, a rare vascular condition with limited approved treatment options.

The submission is supported by data from the Phase 3 SELVA study, which the company said showed statistically significant results across all endpoints and a favorable tolerability profile.

The therapy has received multiple regulatory designations, including FDA Breakthrough Therapy, Orphan Drug, and Fast Track status, along with support from an Orphan Products Development grant.

Palvella said it expects to complete the NDA submission process in the second half of 2026, with a potential U.S. launch in the first half of 2027 if approved.

The company continues to focus on developing therapies for rare diseases with high unmet medical need, particularly in dermatologic and vascular conditions.