---
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"
generated_at: "2026-08-18T13:04:11.896232+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Oncolytics aligns with FDA on pivotal Part B expansion for REO 033 colorectal cancer study

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001129928-26-000053
- JSON: https://secwatch.observer/filing/0001129928-26-000053.json
- Plain text: https://secwatch.observer/filing/0001129928-26-000053.txt

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