secwatch.observer — SEC 8-K summary
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Issuer:     ONCOLYTICS BIOTECH INC (ONCY)
CIK:        0001129928
Form:       8-K
Filed at:   2026-04-06T23:59:59+00:00
Accession:  0001129928-26-000024
Event type: regulatory
Sentiment:  positive
Materiality: 0.55
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1129928/000112992826000024/0001129928-26-000024-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1129928/000112992826000024/oncy-20260406.htm
  HTML page:      https://secwatch.observer/filing/0001129928-26-000024

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer