{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-027129","form_type":"8-K","ticker":"CRSP","cik":"0001674416","company_name":"CRISPR Therapeutics AG","filed_at":"2023-06-09T23:59:59+00:00","discovered_at":"2026-05-14T18:03:39.979690+00:00","generated_at":"2026-06-14T03:59:09.488731+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts exa-cel BLAs; pivotal trials meet primary endpoints in SCD and TDT","bullets":["FDA granted Priority Review for SCD (PDUFA Dec 8, 2023) and Standard Review for TDT (PDUFA Mar 30, 2024).","In TDT, 24/27 (88.9%) achieved transfusion-independence ≥12 months; mean duration 20.5 months.","In SCD, 16/17 (94.1%) achieved freedom from vaso-occlusive crises ≥12 months; mean duration 18.7 months.","Safety profile consistent with busulfan conditioning; no deaths or discontinuations related to exa-cel.","Data from 83 patients (48 TDT, 35 SCD) with follow-up up to 43.7 months presented at EHA 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-027129","json":"https://secwatch.observer/filing/0000950170-23-027129.json","markdown":"https://secwatch.observer/filing/0000950170-23-027129.md","text":"https://secwatch.observer/filing/0000950170-23-027129.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1674416/000095017023027129/0000950170-23-027129-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1674416/000095017023027129/crsp-20230608.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T03:59:09.488731+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"}