{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-011476","form_type":"8-K","ticker":"CRSP","cik":"0001674416","company_name":"CRISPR Therapeutics AG","filed_at":"2023-04-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:39.979282+00:00","generated_at":"2026-06-17T07:04:14.551658+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":"CRISPR and Vertex complete rolling BLA submission to FDA for exa-cel for SCD and TDT","bullets":["Completed rolling Biologics License Applications for exa-cel for sickle cell disease and transfusion-dependent beta thalassemia.","Requests Priority Review; if granted, FDA review shortened to 8 months vs 12.","Supported by Phase 3 data from CLIMB-111, CLIMB-121, and long-term follow-up CLIMB-131.","EU and UK filings submitted Dec 2022, validated by EMA and MHRA in Jan 2023.","Exa-cel has RMAT, Fast Track, Orphan Drug, and Rare Pediatric Disease designations from FDA."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-011476","json":"https://secwatch.observer/filing/0000950170-23-011476.json","markdown":"https://secwatch.observer/filing/0000950170-23-011476.md","text":"https://secwatch.observer/filing/0000950170-23-011476.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1674416/000095017023011476/0000950170-23-011476-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1674416/000095017023011476/crsp-20230331.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T07:04:14.551658+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"}