Palvella's Qtorin Rapamycin NDA Granted Rolling Review By FDA For Treatment Of Microcystic LM

India, June 22 -- Palvella Therapeutics, Inc. (PVLA), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted rolling review for the new drug application of Qtorin rapamycin in the treatment of Microcystic Lymphatic Malformations or mLM.

Qtorin Rapamycin is Palvella's lead candidate, designed to deliver rapamycin directly to pathogenic skin tissue to inhibit disease-driving mTOR signaling while minimizing systemic exposure. The therapy has received Breakthrough Therapy, Orphan Drug, and Fast Track designations for the treatment of mLMs.

Microcystic Lymphatic Malformation, or mLM, is a rare genetic disease of the lymphatic system driven by dysregulation of the PI3K/mTOR pathway. The dise...