PVLA submits initial New Drug Application module for QTORIN, targeting microcystic lymphatic malformations with FDA designations.
Palvella Therapeutics (NASDAQ:PVLA) submitted the first module of its New Drug Application (NDA) to the FDA for QTORIN 3.9% rapamycin anhydrous gel, a treatment for microcystic lymphatic malformations. The filing marks a key step toward potential approval for the rare disease therapy, which currently has no FDA-approved treatments.
The company plans to complete the remaining NDA modules by the second half of 2026. QTORIN has received Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA, expediting the review process. A rolling review was granted earlier this month, further accelerating the timeline.
Palvella aims for a possible U.S. commercial launch in early 2027, contingent on FDA approval. CEO Wes Kaupinen emphasized the urgency in advancing QTORIN as the first potential therapy for patients with microcystic lymphatic malformations.