{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-021008","form_type":"8-K","ticker":"BCYC","cik":"0001761612","company_name":"BICYCLE THERAPEUTICS PLC","filed_at":"2023-02-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:46.449168+00:00","generated_at":"2026-06-19T14:14:49.314763+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 announces Phase I BT8009 results: 50% ORR in urothelial cancer, well tolerated","bullets":["50% overall response rate (ORR) and 75% clinical benefit rate in urothelial cancer at 5 mg/m2; one complete response.","Median duration of response estimated ~14 months; two of four responders remain on therapy as of Jan 2023.","Confirmed partial responses in NSCLC and breast cancer patients, both Nectin-4 positive.","Well tolerated: low rates of skin rash, neuropathy, pneumonitis; no Grade 3+ related events at 5 mg/m2.","BT8009 advancing into dose expansion (up to 66 patients) and combination trial with pembrolizumab planned."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-021008","json":"https://secwatch.observer/filing/0001104659-23-021008.json","markdown":"https://secwatch.observer/filing/0001104659-23-021008.md","text":"https://secwatch.observer/filing/0001104659-23-021008.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1761612/000110465923021008/0001104659-23-021008-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1761612/000110465923021008/tm236546d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-19T14:14:49.314763+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"}