---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-273405"
form_type: "8-K"
ticker: "AVLN"
cik: "0001540171"
company_name: "Avalyn Pharma Inc."
filed_at: "2026-06-17T12:03:19+00:00"
generated_at: "2026-06-17T12:05:14.350021+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Avalyn completes Phase 2b MIST trial enrollment of 375 patients for inhaled pirfenidone in PPF; topline data H2 2027

## Summary
- Completed target enrollment of 375 patients in Phase 2b MIST trial of AP01 (inhaled pirfenidone) for progressive pulmonary fibrosis (PPF).
- Trial is randomized, double-blind, placebo-controlled, evaluating two doses (50 mg and 100 mg BID) vs placebo; primary endpoint is change in FVC at 52 weeks.
- Additional patients in screening remain eligible for randomization over next several weeks; enrollment completed ahead of schedule.
- Topline 12-month clinical results expected in the second half of 2027.
- AP01's tolerability profile may enable longer treatment duration, based on ATLAS Phase 1b and open-label extension data.

## SEC filing metadata
- accession: 0001193125-26-273405
- form_type: 8-K
- ticker: AVLN
- cik: 0001540171
- company_name: Avalyn Pharma Inc.
- filed_at: 2026-06-17T12:03:19+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1540171/000119312526273405/0001193125-26-273405-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1540171/000119312526273405/ck0001540171-20260617.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-273405
- JSON: https://secwatch.observer/filing/0001193125-26-273405.json
- Plain text: https://secwatch.observer/filing/0001193125-26-273405.txt

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