{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-270286","form_type":"8-K","ticker":"ELDN","cik":"0001404281","company_name":"Eledon Pharmaceuticals, Inc.","filed_at":"2025-11-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.320712+00:00","generated_at":"2026-05-16T23:00:39.879706+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Eledon Phase 2 BESTOW trial: tegoprubart eGFR 69 vs tacrolimus 66, primary endpoint not met but safety superior","bullets":["Primary efficacy endpoint (eGFR at 12 months) did not reach statistical significance: 69 vs 66 mL/min/1.73 m².","New-onset diabetes 1/47 on tegoprubart vs ~1/6 on tacrolimus; tremor 1.6% vs 25.0%; delayed graft function 14.3% vs 25.0%.","Efficacy failure composite (death, graft loss, BPAR) was 22% tegoprubart vs 17% tacrolimus, meeting non-inferiority margin.","Cash, equivalents, and short-term investments approximately $93.4M as of Sept 30, 2025, expected to fund operations to late 2026.","Company plans to advance tegoprubart into Phase 3 after regulatory discussions on study design and data requirements."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-270286","json":"https://secwatch.observer/filing/0001193125-25-270286.json","markdown":"https://secwatch.observer/filing/0001193125-25-270286.md","text":"https://secwatch.observer/filing/0001193125-25-270286.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1404281/000119312525270286/0001193125-25-270286-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1404281/000119312525270286/eldn-20251106.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T23:00:39.879706+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"}