{"schema_version":"secwatch.filing_event.v1","accession":"0001854270-25-000069","form_type":"8-K","ticker":"SNTI","cik":"0001854270","company_name":"Senti Biosciences, Inc.","filed_at":"2025-06-18T23:59:59+00:00","discovered_at":"2026-05-14T18:02:50.171958+00:00","generated_at":"2026-05-19T03:25:12.717372+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Senti Bio receives FDA Orphan Drug Designation for SENTI-202 CAR NK therapy in AML","bullets":["FDA granted Orphan Drug Designation to SENTI-202 for relapsed/refractory hematologic malignancies, including AML.","SENTI-202 is a first-in-class Logic Gated CD33 OR FLT3 NOT EMCN CAR NK cell therapy.","Phase 1 trial (NCT06325748) is ongoing; median survival for relapsed/refractory AML is 5.3 months.","Designation provides tax credits, FDA fee exemptions, and potential 7-year market exclusivity.","Approximately 20,800 new AML cases per year in the US, with 60% relapsing or dying within 12 months."],"urls":{"canonical":"https://secwatch.observer/filing/0001854270-25-000069","json":"https://secwatch.observer/filing/0001854270-25-000069.json","markdown":"https://secwatch.observer/filing/0001854270-25-000069.md","text":"https://secwatch.observer/filing/0001854270-25-000069.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1854270/000185427025000069/0001854270-25-000069-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1854270/000185427025000069/snti-20250618.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T03:25:12.717372+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"}