Palvella Completes FDA Pre-NDA Meeting

Palvella Therapeutics announced completion of its pre-new drug application meeting with FDA for Qtorin 3.9% rapamycin anhydrous gel in microcystic lymphatic malformations. The pre-NDA meeting addressed nonclinical, clinical pharmacology, and clinical information for the planned NDA and included an in-person discussion with FDA and receipt of official meeting minutes. Following the in-person pre-NDA meeting with FDA and receipt of official meeting minutes, Palvella remains on track to submit its NDA for Qtorin rapamycin in microcystic LMs in the second half of 2026. Palvella and FDA discussed the planned NDA evidence package, which is expected to include efficacy and safety data from Palvella's Phase 3 SELVA study, including blinded independent review data and before-and-after photographs from all patients enrolled in the study, as well as supportive clinical data from the Phase 2 study that served as the basis for FDA's Breakthrough Therapy designation for Qtorin rapamycin in microcystic LMs. In addition, consistent with the goals of FDA's May 2026 drug repurposing initiative to help address unmet medical needs, particularly for chronic or rare diseases, the evidence package is expected to include real-world evidence from published literature and clinical experience with off-label rapamycin in microcystic LMs. Based on the official meeting minutes and the planned NDA evidence package discussed with FDA, Palvella plans to proceed with the NDA submission, supported by the existing evidence package, with no additional efficacy study planned.