8-K
filed April 6, 2026, 7:59 PM ET
ticker ONCY
CIK 0001129928
regulatory
confidence high
sentiment positive
materiality 0.55
Oncolytics schedules Type C FDA meeting for pelareorep single-arm study in anal cancer
ONCOLYTICS BIOTECH INC
- FDA meeting set for April 16, 2026 to discuss single-arm pivotal study of pelareorep + checkpoint inhibitor in SCAC.
- Proposed enrollment of 60-70 second-line+ patients with no approved therapy; primary endpoint ORR for full approval.
- GOBLET Cohort 4 achieved ~30% ORR and median DOR of 17 months vs real-world 10-14% ORR and 9.5 months DOR.
- SCAC is a rare cancer with ~54,000 annual global cases; anal cancer market projected to reach $2.3B by 2035.
Machine-readable event card
- schema_version
- secwatch.filing_event.v1
- accession
- 0001129928-26-000024
- form_type
- 8-K
- ticker
- ONCY
- cik
- 0001129928
- company_name
- ONCOLYTICS BIOTECH INC
- filed_at
- 2026-04-06T23:59:59+00:00
- discovered_at
- 2026-05-14T18:02:31.988492+00:00
- generated_at
- 2026-05-15T07:14:04.856288+00:00
- sec_items
- ["8.01", "9.01"]
- event_type
- regulatory
- sentiment
- positive
- materiality_score
- 0.55
- calibrated_materiality_score
- 0.55
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0001129928-26-000024
- json_url
- https://secwatch.observer/filing/0001129928-26-000024.json
- markdown_url
- https://secwatch.observer/filing/0001129928-26-000024.md
- text_url
- https://secwatch.observer/filing/0001129928-26-000024.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1129928/000112992826000024/0001129928-26-000024-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1129928/000112992826000024/oncy-20260406.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
- machine_generated
- human_reviewed
- false
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- correction_timestamp
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