{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-411011","form_type":"8-K","ticker":"CGEM","cik":"0001789972","company_name":"Cullinan Therapeutics, Inc.","filed_at":"2026-10-01T23:35:44+00:00","discovered_at":"2026-10-02T10:05:00.230864+00:00","generated_at":"2026-10-12T14:29:55.606364+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Cullinan starts FDA NDA submission for zipalertinib combo in 1L EGFR ex20ins NSCLC under RTOR","bullets":["NDA submission initiated for zipalertinib plus platinum-based chemotherapy in previously untreated, locally advanced or metastatic EGFR exon 20 insertion NSCLC.","Submission is under the FDA's Real-Time Oncology Review program; completion of the NDA submission expected by year-end 2026.","Based on Phase 3 REZILIENT3, which met its primary endpoint with a statistically significant improvement in median PFS vs chemotherapy alone; data presented at IASLC 2026 WCLC Presidential Symposium.","A separate NDA seeking accelerated approval for zipalertinib monotherapy in second-line EGFR ex20ins NSCLC remains under FDA review, with a PDUFA target action date of February 27, 2027.","Cullinan is eligible for $30.0 million and up to $100.0 million in Taiho milestone payments upon U.S. second-line and first-line approvals, respectively."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-411011","json":"https://secwatch.observer/filing/0001193125-26-411011.json","markdown":"https://secwatch.observer/filing/0001193125-26-411011.md","text":"https://secwatch.observer/filing/0001193125-26-411011.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/0001193125-26-411011-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/cgem-20261001.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:29:55.606364+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"}