Research Reports

Key takeaways

100% of bleeding patients achieved statistically significant improvement on cVM-IGA Bleeding at Week 12 (p=0.003).

All bleeding patients reported satisfaction with QTORIN rapamycin on Treatment Satisfaction Questionnaire.

Baseline interviews revealed multidimensional QoL burden beyond clinical severity.

QTORIN rapamycin could become first FDA-approved therapy for cutaneous venous malformations in U.S.

Data presented at SID 2026 annual meeting.

Full analysis

Palvella Therapeutics announced new data from its Phase 2 TOIVA trial of QTORIN rapamycin in cutaneous venous malformations at the SID 2026 meeting. The single-arm, open-label trial met multiple endpoints, with 100% of patients with bleeding at baseline showing statistically significant improvement on the cVM-IGA Bleeding scale (mean +2.5 points, p=0.003) and reporting satisfaction. Baseline qualitative interviews highlighted the substantial physical, functional, and psychosocial burden of the disease. The company positions QTORIN rapamycin as a potential first FDA-approved therapy for the estimated >75,000 U.S. patients. The data supports ongoing development and regulatory discussions.

PVLA · Palvella Therapeutics, Inc.

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