Palvella Therapeutics (NASDAQ:PVLA) said the U.S. Food and Drug Administration has granted Fast Track Designation to QTORIN 3.9% rapamycin anhydrous gel for treating angiokeratomas, a dermatologic condition with no currently approved therapies.
The decision could accelerate development timelines and potentially enable pathways such as Accelerated Approval and Priority Review if subsequent trial results meet regulatory criteria.
The company plans to run a Phase 2 study enrolling roughly 10 to 20 patients, with an FDA meeting targeted for the first half of 2026 and study initiation expected in the second half of the year.
Angiokeratomas, which can cause bleeding, pain, and cosmetic concerns, affect an estimated 50,000 or more diagnosed patients in the U.S., Palvella said.
The Fast Track status follows earlier clinical progress in the company’s QTORIN platform, designed to deliver rapamycin into deeper skin layers while maintaining systemic safety.
Palvella has been expanding its topical mTOR inhibitor pipeline across multiple rare dermatologic conditions.