secwatch.observer — SEC 8-K summary
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Issuer:     ONCOLYTICS BIOTECH INC (ONCY)
CIK:        0001129928
Form:       8-K
Filed at:   2026-07-13T13:03:54+00:00
Accession:  0001129928-26-000043
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Oncolytics: FDA Type D meeting in Aug; half of REO 033 sites activated, >20 patients pre-identified
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- Company to hold Type D meeting with FDA in first half of August 2026 to discuss registrational design for REO 033 Part B.
- Approximately half of planned clinical sites for REO 033 Part A activated by end of July; more than 20 patients pre-identified.
- Initial tumor response update from Part A expected by year-end 2026; Part B enrollment could begin Q1 2027 subject to FDA feedback.
- Pelareorep has Fast Track designation from FDA for RAS-mutant MSS metastatic colorectal cancer.
- Global lead PI Dr. Sanjay Goel opened enrollment at Rutgers Cancer Institute; remaining sites to be activated by end of August.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1129928/000112992826000043/0001129928-26-000043-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1129928/000112992826000043/oncy-20260713.htm
  HTML page:      https://secwatch.observer/filing/0001129928-26-000043

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