Palvella Phase 2 TOIVA study: 73% of patients improved; plans FDA discussions for Breakthrough Therapy

PALVELLA THERAPEUTICS, INC.

73% (11/15) improved on Overall cVM-IGA at Week 12; 67% rated "Much Improved" or "Very Much Improved".
Statistical significance on multiple endpoints, including Overall cVM-IGA (p<0.001) and PGI-C (p<0.001).
QTORIN rapamycin generally well-tolerated; no drug-related SAEs; most common AE application site erythema (25%).
Company plans near-term FDA discussions for Breakthrough Therapy Designation and Phase 3 pivotal study.
Potential first FDA-approved therapy for cutaneous venous malformations affecting >75,000 patients in US.

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