Overview
- Palvella received FDA Fast Track designation for QTORIN 3.9% rapamycin gel to treat angiokeratomas, enabling more frequent FDA interactions and potential eligibility for accelerated approval and priority review if criteria are met.
- The company plans an FDA meeting in the first half of 2026 to finalize the design of a Phase 2 study enrolling about 10–20 patients, with trial initiation expected in the second half of 2026.
- Angiokeratomas are superficial vascular malformations of lymphatic origin that can bleed and cause pain, and they were reclassified in 2025 as an isolated lymphatic malformation with more than 50,000 diagnosed U.S. patients and no approved therapies.
- In a separate program reported a day earlier, Palvella’s Phase 2 TOIVA study in cutaneous venous malformations showed 73% of participants improved at Week 12 and 67% were rated much or very much improved, with no participants rated worse.
- Safety findings in that study were mainly mild or moderate application-site reactions such as erythema, and rapamycin plasma levels were below the 2 ng/mL assay limit at all measured timepoints.