{"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","discovered_at":"2026-06-17T12:05:00.428960+00:00","generated_at":"2026-06-17T12:05:14.350021+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Avalyn completes Phase 2b MIST trial enrollment of 375 patients for inhaled pirfenidone in PPF; topline data H2 2027","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-273405","json":"https://secwatch.observer/filing/0001193125-26-273405.json","markdown":"https://secwatch.observer/filing/0001193125-26-273405.md","text":"https://secwatch.observer/filing/0001193125-26-273405.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T12:05:14.350021+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}