Palvella Therapeutics Reports Positive Phase 2 Results for QTORIN Rapamycin in Cutaneous Venous Malformations

Reuters12-15

<a href="https://laohu8.com/S/PVLA">Palvella Therapeutics</a> Reports Positive Phase 2 Results for QTORIN Rapamycin in Cutaneous Venous Malformations

Palvella Therapeutics Inc. announced topline results from its Phase 2 TOIVA study evaluating QTORIN™ rapamycin for the treatment of cutaneous venous malformations (cVM). The data showed that 73% of participants improved on the Overall cVM-IGA at Week 12. QTORIN™ rapamycin was generally well-tolerated, with no drug-related serious adverse events reported and only mild to moderate treatment-related adverse events, primarily application site reactions. Based on these results, Palvella plans to engage in near-term discussions with the FDA regarding the potential for Breakthrough Therapy Designation and a Phase 3 pivotal study. The results are planned for presentation at future medical meetings. The FDA has previously granted Fast Track Designation to QTORIN™ rapamycin for the treatment of venous malformations.

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: GNW9602001-en) on December 15, 2025, and is solely responsible for the information contained therein.

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The data showed that 73% of participants improved on the Overall cVM-IGA at Week 12. QTORIN™ rapamycin was generally well-tolerated, with no drug-related serious adverse events reported and only mild to moderate treatment-related adverse events, primarily application site reactions. Based on these results, Palvella plans to engage in near-term discussions with the FDA regarding the potential for Breakthrough Therapy Designation and a Phase 3 pivotal study. The results are planned for presentation at future medical meetings. The FDA has previously granted Fast Track Designation to QTORIN™ rapamycin for the treatment of venous malformations.\n      \n\nDisclaimer: 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. 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