Palvella Therapeutics Completes Rolling Submission of NDA for QTORIN Rapamycin

08:08 AM EDT, 08/31/2026 (MT Newswires) -- Palvella Therapeutics (PVLA) said Monday it has completed the rolling submission of a new drug application seeking approval of QTORIN 3.9% rapamycin anhydrous gel to treat microcystic lymphatic malformations. The NDA includes phase 3 trial results, with all six efficacy endpoints achieving statistical significance and 86% of evaluated participants aged 6 and older rated "much improved" or "very much improved" at week 24, the company said. The Food and Drug Administration is expected to decide within 60 days whether to accept the application for filing and whether priority review will be granted, the company said, adding that it is preparing for a potential US launch in H1 2027. Palvella shares were 1.2% higher in premarket trading.