{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-092435","form_type":"8-K","ticker":"EQ","cik":"0001746466","company_name":"Equillium, Inc.","filed_at":"2025-04-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.572614+00:00","generated_at":"2026-05-23T07:09:54.473750+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Equillium announces FDA declined Breakthrough Therapy and Accelerated Approval for itolizumab in aGVHD","bullets":["FDA declined Breakthrough Therapy designation and Accelerated Approval for itolizumab in aGVHD based on EQUATOR study data.","FDA focused on Day 29 outcomes; itolizumab did not show improvement by Day 29 despite favorable safety and longer-term data.","Company plans to accelerate closure of EQUATOR study and evaluate options to advance or partner itolizumab.","Cash and equivalents $14.5M as of March 31, 2025; expected to fund operations into Q3 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-092435","json":"https://secwatch.observer/filing/0001193125-25-092435.json","markdown":"https://secwatch.observer/filing/0001193125-25-092435.md","text":"https://secwatch.observer/filing/0001193125-25-092435.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1746466/000119312525092435/0001193125-25-092435-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1746466/000119312525092435/d787196d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T07:09:54.473750+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"}