{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-128241","form_type":"8-K","ticker":"BCYC","cik":"0001761612","company_name":"BICYCLE THERAPEUTICS PLC","filed_at":"2024-12-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.516242+00:00","generated_at":"2026-05-29T03:40:00.194586+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Bicycle Therapeutics Reports Positive Zelenectide Pevedotin Data in Multiple Cancers","bullets":["Zelenectide pevedotin plus pembrolizumab showed 60% ORR in 22 first-line cisplatin-ineligible mUC patients.","Breast cancer patients with NECTIN4 gene amplification had 62.5% ORR (5/8) vs. 14.3% in all evaluable patients.","NSCLC patients with NECTIN4 gene amplification achieved 40.0% ORR (2/5); no responses in non-amplified patients.","Company plans Phase 1/2 trials in NECTIN4-amplified breast, lung, and other cancers in 2025.","Dose selection and topline data from Phase 2/3 Duravelo-2 trial expected in 2H 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-128241","json":"https://secwatch.observer/filing/0001104659-24-128241.json","markdown":"https://secwatch.observer/filing/0001104659-24-128241.md","text":"https://secwatch.observer/filing/0001104659-24-128241.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1761612/000110465924128241/0001104659-24-128241-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1761612/000110465924128241/tm2430827d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-29T03:40:00.194586+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"}