{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-22-018864","form_type":"8-K","ticker":"CRSP","cik":"0001674416","company_name":"CRISPR Therapeutics AG","filed_at":"2022-09-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:56.614119+00:00","generated_at":"2026-06-23T07:15:56.007481+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA grants rolling review for CRISPR/Vertex exa-cel; submissions planned Q4 2022 / Q1 2023","bullets":["FDA granted rolling review for exa-cel BLA for sickle cell disease and transfusion-dependent beta thalassemia.","BLA submission starts November 2022; completion expected by end of Q1 2023.","EMA and MHRA submissions on track for submission by end of 2022.","Exa-cel holds FDA RMAT, Fast Track, Orphan Drug designations; EMA PRIME and Orphan Drug."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-22-018864","json":"https://secwatch.observer/filing/0000950170-22-018864.json","markdown":"https://secwatch.observer/filing/0000950170-22-018864.md","text":"https://secwatch.observer/filing/0000950170-22-018864.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1674416/000095017022018864/0000950170-22-018864-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1674416/000095017022018864/crsp-20220927.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T07:15:56.007481+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"}