---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-065159"
form_type: "8-K"
ticker: "PVLA"
cik: "0001583648"
company_name: "PALVELLA THERAPEUTICS, INC."
filed_at: "2026-02-24T23:59:59+00:00"
generated_at: "2026-05-16T00:48:11.917776+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Palvella Phase 3 SELVA study of QTORIN rapamycin meets primary endpoint with p<0.001; NDA planned H2 2026

## Summary
- Primary endpoint achieved: mean +2.13 improvement on mLM-IGA (p<0.001); all secondary endpoints met (p<0.001).
- 86% of completers rated 'Much Improved' or better; 95% improved at least 1 point.
- Well-tolerated: no drug-related SAEs; systemic rapamycin levels <2 ng/mL at all timepoints.
- NDA submission to FDA planned H2 2026; potential approval H1 2027 for first approved therapy for microcystic LMs.
- 98% of eligible participants chose to continue in extension period.

## SEC filing metadata
- accession: 0001193125-26-065159
- form_type: 8-K
- ticker: PVLA
- cik: 0001583648
- company_name: PALVELLA THERAPEUTICS, INC.
- filed_at: 2026-02-24T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1583648/000119312526065159/0001193125-26-065159-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1583648/000119312526065159/pvla-20260224.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-065159
- JSON: https://secwatch.observer/filing/0001193125-26-065159.json
- Plain text: https://secwatch.observer/filing/0001193125-26-065159.txt

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