{"schema_version":"secwatch.filing_event.v1","accession":"0001129928-26-000053","form_type":"8-K","ticker":"ONCY","cik":"0001129928","company_name":"ONCOLYTICS BIOTECH INC","filed_at":"2026-08-18T13:03:30+00:00","discovered_at":"2026-08-18T13:04:00.367843+00:00","generated_at":"2026-08-18T13:04:11.896232+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Oncolytics aligns with FDA on pivotal Part B expansion for REO 033 colorectal cancer study","bullets":["FDA written feedback supports potential pivotal Part B expansion of REO 033 in 2L RAS-mutant MSS colorectal cancer.","Alignment on accelerated approval based on objective response rate; progression-free survival supports full approval.","Company to skip scheduled Type D meeting; will pursue End-of-Phase meeting for final registration program agreement.","Part B start-up activities to begin after positive interim Part A data; prior REO 022 data showed improved ORR, PFS, OS.","Pelareorep combination has FDA Fast Track designation in this patient population."],"urls":{"canonical":"https://secwatch.observer/filing/0001129928-26-000053","json":"https://secwatch.observer/filing/0001129928-26-000053.json","markdown":"https://secwatch.observer/filing/0001129928-26-000053.md","text":"https://secwatch.observer/filing/0001129928-26-000053.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1129928/000112992826000053/0001129928-26-000053-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1129928/000112992826000053/oncy-20260818.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-18T13:04:11.896232+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"}