KIRITSY CHRISTOPHER P sold $49K of PVLA

Palvella Therapeutics (NASDAQ:PVLA) presented data from its Phase 3 SELVA study of QTORIN rapamycin gel, showing 95% of participants improved on the primary endpoint. The company also shared results from a pharmacokinetic substudy and a real-world claims analysis of DSAP patients. Palvella completed its FDA application for QTORIN in August 2026 and plans a Phase 2 trial for QTORIN pitavastatin in Q4 2026.

Palvella Therapeutics reported Phase 3 SELVA interview data showing improvements and high satisfaction with QTORIN rapamycin. The company also presented PK data with ≥40-fold lower exposure vs oral sirolimus and a claims analysis estimating 154,986 diagnosed DSAP patients in the U.S. according to the company.

Palvella Therapeutics (Nasdaq: PVLA) presented data at a dermatology conference. Phase 3 SELVA study results showed QTORIN™ rapamycin improved symptoms of microcystic lymphatic malformations (microcystic LMs) with high treatment satisfaction. A real-world claims analysis estimated 154,986 U.S. patients diagnosed with disseminated superficial actinic porokeratosis (DSAP) over eight years.

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) received FDA funding for its Phase 3 SELVA trial of QTORIN rapamycin for microcystic lymphatic malformations. The trial met all efficacy endpoints. The company plans a U.S. launch in 2027 if approved. PVLA stock closed at $138.16, up 0.97% in pre-market trading.

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.