{"schema_version":"secwatch.filing_event.v1","accession":"0001453687-25-000050","form_type":"8-K","ticker":"RNAC","cik":"0001453687","company_name":"Cartesian Therapeutics, Inc.","filed_at":"2025-01-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.659273+00:00","generated_at":"2026-05-27T09:11:07.802647+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":"Cartesian Therapeutics receives FDA SPA agreement for Phase 3 AURORA trial of Descartes-08 in MG","bullets":["FDA agrees under Special Protocol Assessment that Phase 3 AURORA trial design can support future BLA for Descartes-08 in myasthenia gravis.","Phase 3 trial expected to start in first half of 2025; randomized, placebo-controlled, 100 AChR Ab+ participants.","Primary endpoint: proportion with ≥3-point MG-ADL improvement at Month 4 vs placebo; 1:1 randomization.","Phase 2b data showed average MG-ADL reduction of 5.5 (±1.1) at Month 4 (n=12); well-tolerated without preconditioning chemo.","SPA provides regulatory clarity and a clear path toward potential approval of Descartes-08."],"urls":{"canonical":"https://secwatch.observer/filing/0001453687-25-000050","json":"https://secwatch.observer/filing/0001453687-25-000050.json","markdown":"https://secwatch.observer/filing/0001453687-25-000050.md","text":"https://secwatch.observer/filing/0001453687-25-000050.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1453687/000145368725000050/0001453687-25-000050-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1453687/000145368725000050/rnac-20250127.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T09:11:07.802647+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"}