{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-045198","form_type":"8-K","ticker":"BCYC","cik":"0001761612","company_name":"BICYCLE THERAPEUTICS PLC","filed_at":"2026-04-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.869098+00:00","generated_at":"2026-05-15T05:20:57.669573+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Bicycle Therapeutics: nuzefatide 40% ORR in EphA2+ mUC; Phase 2 PDAC trial dosed","bullets":["Nuzefatide + nivolumab in 14 mUC patients: 40% ORR in EphA2+ tumors; 100% ORR (3/3) in MMAE-naïve EphA2+ tumors.","Preferred monotherapy dose identified as 8mg/m2 Q2W; first patient dosed in Phase 2 trial for 2L+ pancreatic ductal adenocarcinoma.","Human imaging data with EphA2 BIA detected PDAC metastases in 15/18 patients; validates EphA2 as a novel target.","No Grade ≥3 TRAEs of clinical interest with combination; differentiated safety profile vs other EphA2-targeted agents."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-045198","json":"https://secwatch.observer/filing/0001104659-26-045198.json","markdown":"https://secwatch.observer/filing/0001104659-26-045198.md","text":"https://secwatch.observer/filing/0001104659-26-045198.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1761612/000110465926045198/0001104659-26-045198-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1761612/000110465926045198/tm2612166d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T05:20:57.669573+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"}