---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-225317"
form_type: "8-K"
ticker: "PVLA"
cik: "0001583648"
company_name: "PALVELLA THERAPEUTICS, INC."
filed_at: "2026-05-15T11:30:16+00:00"
generated_at: "2026-05-15T11:35:25.409851+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Palvella reports Phase 2 TOIVA data: 100% bleed improvement, p=0.003

## Summary
- 100% of patients with bleeding at baseline showed statistically significant improvement on cVM-IGA Bleeding at Week 12 (mean +2.5, p=0.003).
- All bleeding patients reported 'satisfied' or 'very satisfied' with QTORIN rapamycin on Treatment Satisfaction Questionnaire at Week 12.
- Baseline patient interviews show QoL burden includes pain, physical limitations, emotional distress from lesion visibility.
- QTORIN rapamycin could become first FDA-approved therapy for cutaneous venous malformations, targeting >75,000 U.S. patients.
- Data presented at 83rd SID Annual Meeting in Chicago on May 15, 2026.

## SEC filing metadata
- accession: 0001193125-26-225317
- form_type: 8-K
- ticker: PVLA
- cik: 0001583648
- company_name: PALVELLA THERAPEUTICS, INC.
- filed_at: 2026-05-15T11:30:16+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/1583648/000119312526225317/0001193125-26-225317-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1583648/000119312526225317/pvla-20260515.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-225317
- JSON: https://secwatch.observer/filing/0001193125-26-225317.json
- Plain text: https://secwatch.observer/filing/0001193125-26-225317.txt

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