secwatch.observer — SEC 8-K summary
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Issuer:     ONCOLYTICS BIOTECH INC (ONCY)
CIK:        0001129928
Form:       8-K
Filed at:   2026-08-18T13:03:30+00:00
Accession:  0001129928-26-000053
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1129928/000112992826000053/0001129928-26-000053-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1129928/000112992826000053/oncy-20260818.htm
  HTML page:      https://secwatch.observer/filing/0001129928-26-000053

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