---
schema_version: "secwatch.filing_event.v1"
accession: "0001129928-26-000026"
form_type: "8-K"
ticker: "ONCY"
cik: "0001129928"
company_name: "ONCOLYTICS BIOTECH INC"
filed_at: "2026-04-27T23:59:59+00:00"
generated_at: "2026-05-15T03:43:03.596952+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Oncolytics secures FDA alignment on pivotal anal cancer study for pelareorep

## Summary
- FDA agreed on a randomized controlled pivotal trial design for pelareorep in post-first-line metastatic SCAC, targeting accelerated and full approval.
- Prior pelareorep+checkpoint data showed median duration of response 15.5 months vs 9.5 months SOC; 12-month survival 82% vs 45.7%.
- No FDA-approved therapies exist for SCAC after first-line chemo/checkpoint; over 10,000 US patients affected annually.
- Company will finalize protocol using FDA feedback; study enables multiple endpoint assessments for potential simultaneous approvals.

## SEC filing metadata
- accession: 0001129928-26-000026
- form_type: 8-K
- ticker: ONCY
- cik: 0001129928
- company_name: ONCOLYTICS BIOTECH INC
- filed_at: 2026-04-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1129928/000112992826000026/0001129928-26-000026-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1129928/000112992826000026/oncy-20260427.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001129928-26-000026
- JSON: https://secwatch.observer/filing/0001129928-26-000026.json
- Plain text: https://secwatch.observer/filing/0001129928-26-000026.txt

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