secwatch.observer — SEC 8-K summary
======================================

Issuer:     Avalyn Pharma Inc. (AVLN)
CIK:        0001540171
Form:       8-K
Filed at:   2026-06-17T12:03:19+00:00
Accession:  0001193125-26-273405
Event type: other_material
Sentiment:  positive
Materiality: 0.55
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1540171/000119312526273405/0001193125-26-273405-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1540171/000119312526273405/ck0001540171-20260617.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-273405

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer