{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-125870","form_type":"8-K","ticker":"BCYC","cik":"0001761612","company_name":"BICYCLE THERAPEUTICS PLC","filed_at":"2023-12-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:30.348497+00:00","generated_at":"2026-06-07T12:57:05.195372+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Bicycle Therapeutics reports 38% ORR for BT8009, 39% ORR for BT5528 in mUC; plans Phase 2/3 trial in Q1 2024","bullets":["BT8009 showed 38% ORR in 26 EV-naïve mUC patients; median duration of response 11.1 months; zero severe peripheral neuropathy.","BT7480 demonstrated two unconfirmed partial responses in cervical cancer and three prolonged stable disease (≥7 months).","BT5528 achieved 39% ORR in 18 mUC patients; median DOR 4 months; no bleeding events observed.","Plans to initiate Phase 2/3 Duravelo-2 registrational trial for BT8009 in mUC in Q1 2024.","Next-generation Bicycle conjugates in development; BRC imaging data expected in 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-125870","json":"https://secwatch.observer/filing/0001104659-23-125870.json","markdown":"https://secwatch.observer/filing/0001104659-23-125870.md","text":"https://secwatch.observer/filing/0001104659-23-125870.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1761612/000110465923125870/0001104659-23-125870-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1761612/000110465923125870/tm2332810d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T12:57:05.195372+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"}