{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-099482","form_type":"8-K","ticker":"BCYC","cik":"0001761612","company_name":"BICYCLE THERAPEUTICS PLC","filed_at":"2023-09-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:35.150593+00:00","generated_at":"2026-06-10T21:47:37.878013+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Bicycle Therapeutics aligns with FDA on Phase 2/3 registrational trial for BT8009 in metastatic bladder cancer","bullets":["FDA alignment reached on Duravelo-2 trial design; trial to begin Q1 2024.","Potential accelerated approval based on ORR, with PFS to confirm benefit.","Cohort 1: BT8009 + pembrolizumab in untreated metastatic bladder cancer.","Cohort 2: BT8009 monotherapy and combo in previously treated patients.","Discussions ongoing for confirmatory trial design in second-line-plus setting."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-099482","json":"https://secwatch.observer/filing/0001104659-23-099482.json","markdown":"https://secwatch.observer/filing/0001104659-23-099482.md","text":"https://secwatch.observer/filing/0001104659-23-099482.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1761612/000110465923099482/0001104659-23-099482-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1761612/000110465923099482/tm2325810d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T21:47:37.878013+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"}