Palvella Therapeutics Announces FDA Rolling Review Of Its New Drug Application For Qtorin Rapamycin For The Treatment Of Microcystic Lymphatic Malformations

FDA’s rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted

Palvella remains on track to complete the NDA submission in the second half of 2026

QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,000 individuals with microcystic lymphatic malformations in the U.S.