Palvella Therapeutics is a clinical-stage biopharmaceutical company developing topical therapies for rare skin diseases and vascular malformations that currently have no FDA-approved treatments. Palvella's core innovation is its QTORIN platform, an anhydrous gel formulation technology that delivers drugs deep into the skin at therapeutic concentrations while keeping systemic absorption low. The lead product candidate, QTORIN rapamycin, is a topical gel formulation of rapamycin — a drug already approved in oral form for organ transplant rejection, but whose systemic use is limited by serious side effects including immunosuppression and kidney toxicity. By delivering rapamycin topically, Palvella aims to treat the root cause of mTOR-pathway-driven skin diseases without those risks. QTORIN rapamycin is in development for three indications: microcystic lymphatic malformations (Phase 3 complete, NDA submission planned in the second half of 2026), cutaneous venous malformations (Phase 2 complete, Phase 3 planned), and clinically significant angiokeratomas (Phase 2 planned). A second candidate, QTORIN pitavastatin, targets a premalignant skin condition called DSAP via the mevalonate pathway, with a Phase 2 trial planned. Palvella has no approved products or revenue. The company funds operations through equity financing and a $15M development funding arrangement with Ligand Pharmaceuticals, which carries tiered royalties on future net sales. If approved, Palvella plans to commercialize products directly in the U.S. through specialty pharmacies, targeting a specialty pricing model consistent with rare disease drugs.