---
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"
generated_at: "2026-05-15T07:14:04.856288+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Oncolytics schedules Type C FDA meeting for pelareorep single-arm study in anal cancer

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1129928/000112992826000024/0001129928-26-000024-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1129928/000112992826000024/oncy-20260406.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001129928-26-000024
- JSON: https://secwatch.observer/filing/0001129928-26-000024.json
- Plain text: https://secwatch.observer/filing/0001129928-26-000024.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.