---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-232717"
form_type: "8-K"
ticker: "PVLA"
cik: "0001583648"
company_name: "PALVELLA THERAPEUTICS, INC."
filed_at: "2026-05-20T20:35:15+00:00"
generated_at: "2026-05-20T20:36:52.256361+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-232717
- form_type: 8-K
- ticker: PVLA
- cik: 0001583648
- company_name: PALVELLA THERAPEUTICS, INC.
- filed_at: 2026-05-20T20:35:15+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1583648/000119312526232717/0001193125-26-232717-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1583648/000119312526232717/pvla-20260520.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-232717
- JSON: https://secwatch.observer/filing/0001193125-26-232717.json
- Plain text: https://secwatch.observer/filing/0001193125-26-232717.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.