---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-23-017908"
form_type: "8-K"
ticker: "PVLA"
cik: "0001583648"
company_name: "PALVELLA THERAPEUTICS, INC."
filed_at: "2023-06-21T23:59:59+00:00"
generated_at: "2026-06-13T20:01:12.592291+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# AstraZeneca discontinues Phase 2a trial of elarekibep; lung findings from toxicology study

## Summary
- AstraZeneca ceases dosing in clinical studies of elarekibep (IL-4Rα inhibitor for asthma) due to lung pathology from a 13-week GLP toxicology study.
- Findings include inflammation-mediated lung tissue damage, not dose-related; no clinical observations in study.
- Pieris to expedite review of program implications and reassess corporate priorities before further update.
- Cash balance of $53.2 million as of May 31, 2023 (unaudited).
- Decision independent of Phase 2a data; findings do not support long-term use or later-stage development.

## SEC filing metadata
- accession: 0001437749-23-017908
- form_type: 8-K
- ticker: PVLA
- cik: 0001583648
- company_name: PALVELLA THERAPEUTICS, INC.
- filed_at: 2023-06-21T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1583648/000143774923017908/0001437749-23-017908-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1583648/000143774923017908/pirs20230618_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-23-017908
- JSON: https://secwatch.observer/filing/0001437749-23-017908.json
- Plain text: https://secwatch.observer/filing/0001437749-23-017908.txt

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