sirolimus topical (PTX-367) / Palvella Therapeutics - LARVOL DELTA

Palvella Therapeutics, Inc…said the U.S. Food and Drug Administration has granted Fast Track designation to QTORIN rapamycin for the treatment of angiokeratomas, a rare and chronic skin condition with no approved therapies. (MyChesCo) - "Palvella plans to advance QTORIN rapamycin into a Phase 2 clinical study for clinically significant angiokeratomas, with trial initiation targeted for the second half of 2026. The company expects to meet with the FDA in the first half of 2026 to discuss study design, which is expected to enroll approximately 10 to 20 patients."

Fast track • New P2 trial • Oncology