{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-24-031426","form_type":"8-K","ticker":"AVTX","cik":"0001534120","company_name":"Avalo Therapeutics, Inc.","filed_at":"2024-07-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.422070+00:00","generated_at":"2026-05-31T22:34:55.617561+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Avalo Therapeutics IND for AVTX-009 active; Phase 2 LOTUS trial in hidradenitis suppurativa to commence","bullets":["FDA cleared IND for AVTX-009 (anti-IL-1β mAb) allowing Phase 2 LOTUS trial in moderate-to-severe HS.","LOTUS is a randomized, placebo-controlled trial of ~180 adults with two AVTX-009 dose regimens; primary endpoint HiSCR75 at Week 16.","First patient enrollment expected in 2024; AVTX-009 acquired in late March 2024 with IND filed ~3 months later.","Company believes AVTX-009 may be best-in-class due to target, half-life, and potency allowing convenient dosing."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-24-031426","json":"https://secwatch.observer/filing/0001628280-24-031426.json","markdown":"https://secwatch.observer/filing/0001628280-24-031426.md","text":"https://secwatch.observer/filing/0001628280-24-031426.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1534120/000162828024031426/0001628280-24-031426-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1534120/000162828024031426/avtx-20240709.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T22:34:55.617561+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"}