{"filings":[{"id":1093516,"accession_number":"0001193125-26-273405","cik":1540171,"company_name":"Avalyn Pharma Inc.","ticker":"AVLN","form_type":"8-K","filed_at":"2026-06-17T12:03:19+00:00","items":["7.01","9.01"],"status":"ready","headline":"Avalyn completes Phase 2b MIST trial enrollment of 375 patients for inhaled pirfenidone in PPF; topline data H2 2027","summary_kind":"llm","event_type":"other_material","confidence":"high","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."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":1205232225.9499998,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":815598,"accession_number":"0001193125-26-254581","cik":1540171,"company_name":"Avalyn Pharma Inc.","ticker":"AVLN","form_type":"8-K","filed_at":"2026-06-03T11:25:05+00:00","items":["2.02","9.01"],"status":"ready","headline":"Avalyn Pharma reports Q1 net loss of $26.9M; MIST Phase 2b enrollment on track","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $26.9M in Q1 2026 vs $17.5M in Q1 2025; R&D expense rose to $22.9M.","Cash, equivalents and marketable securities of $123.1M as of March 31, 2026; excludes $316.1M net IPO proceeds raised in May 2026.","MIST Phase 2b trial of AP01 in PPF enrollment on schedule to complete mid-2026; topline data expected H2 2027.","AURA Phase 2 trial of AP02 in IPF underway; first patient dosed March 2026; topline data expected late 2027.","Appointed Adam Golden as General Counsel and Head of BD, and Frank Salisbury as SVP Commercial."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":1205232225.9499998,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":93542,"accession_number":"0001193125-26-201434","cik":1540171,"company_name":"Avalyn Pharma Inc.","ticker":"AVLN","form_type":"8-K","filed_at":"2026-05-01T23:59:59+00:00","items":["5.03","9.01"],"status":"ready","headline":"Avalyn Pharma adopts amended charter and bylaws upon IPO consummation","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Authorizes 500M voting common shares and 200M non-voting common shares.","Authorizes 10M shares of undesignated preferred stock issuable by Board.","Eliminates all references to prior series of preferred stock.","Establishes advance notice procedures for stockholder proposals and director nominations.","Amendments previously disclosed in S-1 Registration Statement; effective upon IPO."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.25,"calibrated_materiality_score":0.25,"market_cap_usd":1205232225.9499998,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}