secwatch / observer

8-K filed February 4, 2026, 6:59 PM ET ticker ONCY CIK 0001129928

regulatory confidence high sentiment positive materiality 0.65

Oncolytics gets FDA Fast Track for pelareorep in 2L KRAS-mutant MSS mCRC; interim data expected YE 2026

ONCOLYTICS BIOTECH INC

FDA Fast Track Designation for pelareorep + bevacizumab + FOLFIRI in second-line KRAS-mutant MSS metastatic colorectal cancer.
Clinical data showed 33% ORR (vs ~10% SOC), 16.6-month PFS (vs 5.7 mo SOC), 27-month OS (vs 11.2 mo SOC).
Company plans controlled study with first site activated March 2026; interim data expected by end of 2026.
Estimated addressable market $3-5 billion annually for this difficult-to-treat population.

item 8.01 item 9.01

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schema_version: secwatch.filing_event.v1
accession: 0001129928-26-000004
form_type: 8-K
ticker: ONCY
cik: 0001129928
company_name: ONCOLYTICS BIOTECH INC
filed_at: 2026-02-04T23:59:59+00:00
discovered_at: 2026-05-14T18:02:34.594287+00:00
generated_at: 2026-05-16T04:48:59.763786+00:00
sec_items: ["8.01", "9.01"]
event_type: regulatory
sentiment: positive
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: high
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json_url: https://secwatch.observer/filing/0001129928-26-000004.json
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text_url: https://secwatch.observer/filing/0001129928-26-000004.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1129928/000112992826000004/0001129928-26-000004-index.htm
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