{"schema_version":"secwatch.filing_event.v1","accession":"0001129928-26-000045","form_type":"8-K","ticker":"ONCY","cik":"0001129928","company_name":"ONCOLYTICS BIOTECH INC","filed_at":"2026-07-20T13:03:03+00:00","discovered_at":"2026-07-20T13:04:00.360435+00:00","generated_at":"2026-07-20T13:04:04.902498+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Oncolytics Biotech receives FDA Fast Track for pelareorep in second-line anal cancer","bullets":["FDA granted Fast Track for pelareorep + checkpoint inhibitor in inoperable/metastatic squamous cell anal carcinoma after prior therapy.","GOBLET study showed ORR ~30% (vs historical ~15%), median DOR ~15.5 months, 12-month OS 82% (vs 45.7%).","No FDA-approved therapies exist for patients progressing after first-line standard of care; estimated US market ~$1B annually.","Third Fast Track designation in GI cancers (after KRAS-mCRC Feb 2026 and pancreatic cancer 2022).","Company believes clear regulatory framework in place for pivotal study following April 2026 FDA meeting."],"urls":{"canonical":"https://secwatch.observer/filing/0001129928-26-000045","json":"https://secwatch.observer/filing/0001129928-26-000045.json","markdown":"https://secwatch.observer/filing/0001129928-26-000045.md","text":"https://secwatch.observer/filing/0001129928-26-000045.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1129928/000112992826000045/0001129928-26-000045-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1129928/000112992826000045/oncy-20260720.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-20T13:04:04.902498+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"}