{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-123816","form_type":"8-K","ticker":"IPSC","cik":"0001850119","company_name":"Century Therapeutics, Inc.","filed_at":"2023-12-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:31.042901+00:00","generated_at":"2026-06-07T17:23:26.173663+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA clears IND for Century's CNTY-101 in systemic lupus erythematosus","bullets":["FDA notified Century that Phase 1 trial of CNTY-101 may proceed in moderate-to-severe SLE patients who failed ≥2 immunosuppressive therapies.","This is the second IND clearance for CNTY-101 and first in autoimmune/inflammatory disease; previous IND for B-cell malignancies.","Trial expected to start H1 2024 with initial data by year-end 2024; evaluates safety, tolerability, PK, clinical response.","CNTY-101 is an allogeneic iPSC-derived NK cell with 6 genetic edits including CD19 CAR, Allo-Evasion, IL-15, and safety switch."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-123816","json":"https://secwatch.observer/filing/0001104659-23-123816.json","markdown":"https://secwatch.observer/filing/0001104659-23-123816.md","text":"https://secwatch.observer/filing/0001104659-23-123816.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1850119/000110465923123816/0001104659-23-123816-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1850119/000110465923123816/tm2332239d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T17:23:26.173663+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"}