$PVLA

Palvella Therapeutics reported positive Phase 3 and Phase 2 clinical data for its topical QTORIN rapamycin gel, showing significant improvement in children with microcystic lymphatic malformations and cutaneous venous malformations. The company has secured multiple FDA designations, including Breakthrough Therapy, Orphan Drug, and Fast Track, for QTORIN rapamycin. Palvella plans to submit a New Drug Application in the second half of 2026 and initiate a new Phase 3 trial, aiming to establish QTORIN rapamycin as a first-in-disease therapy for rare vascular malformations.