Palvella Phase 3 SELVA: 100% of children responded; NDA filing on track for H2 2026

PALVELLA THERAPEUTICS, INC.

Phase 3 SELVA: 100% of 13 children (6-11 yrs) rated 'Much Improved' or better on mLM-IGA at Week 24 (mean +2.46, p<0.001).
87% (20/23) with baseline leaking/bleeding showed 'Much Improved' or better on leaking/bleeding scale at Week 24 (mean +2.48).
Blinded review: pre-treatment stability, then 48% max improvement after 24 weeks (mean mLM-MCSS from 9.9 to 6.6).
Phase 2 TOIVA: stat sig improvements in cVM-MCSS Height (mean -1.50) and Appearance (mean -1.43) at Week 24 (p<0.001).
NDA submission for microcystic LMs planned H2 2026; Phase 3 for cutaneous VMs starts H2 2026.

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