{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-010199","form_type":"8-K","ticker":"CGEM","cik":"0001789972","company_name":"Cullinan Therapeutics, Inc.","filed_at":"2025-01-29T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.879785+00:00","generated_at":"2026-05-27T07:12:31.915991+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Cullinan's zipalertinib meets primary endpoint in Phase 2b NSCLC trial; H2 2025 FDA submission planned","bullets":["REZILIENT1 trial met primary endpoint of overall response rate in NSCLC with EGFR exon 20 insertion mutations after prior therapy.","Safety profile generally consistent with previous data presentations; full results to be submitted for upcoming medical conference.","Pending FDA discussions, companies plan to submit for U.S. regulatory approval in second half of 2025.","Zipalertinib (CLN-081/TAS6417) is a monotherapy for patients who have received prior therapy."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-010199","json":"https://secwatch.observer/filing/0000950170-25-010199.json","markdown":"https://secwatch.observer/filing/0000950170-25-010199.md","text":"https://secwatch.observer/filing/0000950170-25-010199.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1789972/000095017025010199/0000950170-25-010199-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1789972/000095017025010199/cgem-20250128.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T07:12:31.915991+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"}