PALVELLA THERAPEUTICS, INC. — Form 8-K

Palvella Therapeutics reported positive Phase 3 SELVA trial results for QTORIN® 3.9% rapamycin anhydrous gel in microcystic lymphatic malformations (mLMs), achieving statistically significant improvements across primary and secondary endpoints (mLM-IGA +2.13, p<0.001). The company completed a pre-NDA meeting with FDA, received rolling review, submitted the first NDA module in Q2 2026, and targets complete NDA submission in 2H 2026 with potential FDA approval and U.S. launch in 1H 2027. The company raised $230 million in an oversubscribed February 2026 financing and maintains $262 million cash (as of 3/31/26), with 2026 projected expenses of $90–95 million GAAP ($105–110 million). The company is pursuing a pipeline-in-a-product strategy, with Phase 2 positive data in cutaneous venous malformations and new programs in angiokeratomas and disseminated superficial actinic porokeratosis targeting announcement by year-end 2026.