{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-031475","form_type":"8-K","ticker":"GERN","cik":"0000886744","company_name":"GERON CORP","filed_at":"2024-03-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:27.151897+00:00","generated_at":"2026-06-04T21:57:04.015441+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Geron: FDA ODAC votes 12-2 in favor of imetelstat's benefit/risk for LR-MDS","bullets":["ODAC voted 12 to 2 that imetelstat's clinical benefit/risk profile is favorable for TD anemia in LR-MDS.","PDUFA target action date for imetelstat NDA is June 16, 2024.","IMerge Phase 3 met primary endpoint: ≥8-week RBC-TI significantly higher vs placebo (p<0.001).","28% (imetelstat) vs 3% (placebo) achieved ≥24-week RBC-TI; median duration for responders was 80 weeks.","Common Grade 3-4 adverse events: thrombocytopenia (62%) and neutropenia (68%); generally manageable."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-031475","json":"https://secwatch.observer/filing/0000950170-24-031475.json","markdown":"https://secwatch.observer/filing/0000950170-24-031475.md","text":"https://secwatch.observer/filing/0000950170-24-031475.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/886744/000095017024031475/0000950170-24-031475-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/886744/000095017024031475/gern-20240314.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T21:57:04.015441+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"}