Palvella's Qtorin Rapamycin NDA Receives FDA Rolling Review for Microcystic LM

Palvella Therapeutics announced the U.S. Food and Drug Administration (FDA) granted a rolling review for its New Drug Application (NDA) for Qtorin™ rapamycin. The drug is intended to treat microcystic lymphatic malformations (LM), a rare and debilitating disease currently lacking FDA-approved therapies. This regulatory decision, announced June 22, 2026, allows Palvella to submit sections of the NDA as they are completed, potentially expediting the review process. The NDA submission is supported by positive data from the pivotal Phase 2/3 RAPP study. Qtorin rapamycin has previously received both Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA. These designations make the therapy eligible for a Priority Review Voucher upon potential approval. The rolling review marks a significant step towards bringing the first potential FDA-approved treatment to patients suffering from microcystic LM, a condition with no currently approved therapeutic options.