{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-101202","form_type":"8-K","ticker":"BCYC","cik":"0001761612","company_name":"BICYCLE THERAPEUTICS PLC","filed_at":"2024-09-19T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.445413+00:00","generated_at":"2026-05-31T03:41:06.124269+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 positive ESMO 2024 data: 45% ORR for zelenectide pevedotin in mUC","bullets":["Zelenectide pevedotin monotherapy in mUC: 45% ORR (38 evaluable patients), 11.1 months median duration of response.","BT5528 in mUC: 45% ORR in 6.5 mg/m² Q2W expansion cohort; EphA2 expression correlates with response.","Low treatment-related peripheral neuropathy: 28% with zelenectide, 19% with BT5528; no Grade ≥3 events.","BT7480 in advanced solid tumors: favorable safety, 13 of 39 patients stable disease, 2 unconfirmed PRs in cervical cancer.","Global Phase 2/3 Duravelo-2 registrational trial for zelenectide pevedotin in mUC is enrolling."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-101202","json":"https://secwatch.observer/filing/0001104659-24-101202.json","markdown":"https://secwatch.observer/filing/0001104659-24-101202.md","text":"https://secwatch.observer/filing/0001104659-24-101202.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1761612/000110465924101202/0001104659-24-101202-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1761612/000110465924101202/tm2424162d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T03:41:06.124269+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"}