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 disease is characterized by abnormal lymphatic vessels or cysts that result in abnormal flow of lymph fluid, known as chronic lymphorrhea, and can cause bleeding and life-threatening infections. There are currently no FDA-approved treatments for patients with mLMs.
The company has previously reported positive results from the Phase 3 SELVA trial of Qtorin Rapamycin, in which the trial met its primary endpoint. Palvella plans to complete the NDA submission in the second half of 2026.
The FDA's rolling review process is intended to facilitate expedited review by allowing the agency to begin evaluating completed sections of an NDA while the company completes the remainder of the application.
In addition to mLMs, Qtorin rapamycin is currently being developed for the treatment of cutaneous venous malformations and clinically significant angiokeratomas.
PVLA is currently trading at $119.57, up 5.72%.
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