Palvella completes rolling FDA NDA submission for QTORIN rapamycin in microcystic lymphatic malformations

• Palvella Therapeutics completed a rolling NDA submission to the FDA for QTORIN 3.9% rapamycin gel to treat microcystic lymphatic malformations.
• FDA granted rolling review; a filing decision and any Priority Review designation are expected within 60 days.
• Phase 3 SELVA trial met the primary endpoint; 86% were rated Much Improved or Very Much Improved at Week 24.
• Palvella targets a potential US launch in the first half of 2027 if the FDA clears the application.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Palvella Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608310730PRIMZONEFULLFEED9818243) on August 31, 2026, and is solely responsible for the information contained therein.