Palvella Receives Additional FDA Funding For QTORIN Rapamycin In Lymphatic Malformations

Palvella Therapeutics (PVLA) is preparing for a potential 2027 U.S. launch of QTORIN 3.9% rapamycin anhydrous gel for microcystic lymphatic malformations. The FDA awarded a third year of grant funding for the Phase 3 SELVA trial, and Palvella completed its New Drug Application in August. The company estimates over 30,000 U.S. patients have this rare condition, with no current FDA-approved therapies.

Palvella Therapeutics (PVLA) completed its NDA submission to the FDA for QTORIN 3.9% rapamycin anhydrous gel, a potential treatment for microcystic lymphatic malformations (microcystic LMs). The NDA includes Phase 3 SELVA trial results, which met primary and secondary endpoints. The therapy has received Breakthrough Therapy, Fast Track, and Orphan Drug designations. Palvella anticipates a potential commercial launch in early 2027, pending approval.

PALVELLA THERAPEUTICS, INC. (PVLA) filed an SEC Form 8-K — Results of Operations and Financial Condition. Palvella Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update First module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of

Palvella Therapeutics (NASDAQ:PVLA) said it filed the initial module of its FDA NDA for QTORIN 3.9% rapamycin anhydrous gel to treat microcystic lymphatic malformations. The company plans to submit remaining NDA modules in late 2026 and prepare for a potential independent U.S. launch in early 2027. QTORIN has Orphan Drug, Fast Track, and Breakthrough Therapy designations.

Palvella Therapeutics said it completed an FDA pre-NDA meeting for QTORIN™ 3.9% rapamycin anhydrous gel in microcystic lymphatic malformations. The company expects to submit an NDA in the second half of 2026, using efficacy and safety data from its Phase 3 SELVA study plus supportive Phase 2 and real-world evidence. Palvella plans no additional efficacy study.

Palvella Therapeutics (Nasdaq: PVLA) said the U.S. Patent and Trademark Office issued U.S. Patent No. 12,636,273, exclusively licensed from Yale, covering topical mevalonate-pathway inhibition with QTORIN pitavastatin for porokeratosis, including DSAP, with protection into 2043. The company plans a Phase 2 DSAP trial in 2H 2026.