regulatory
confidence high
sentiment positive
materiality 0.65
Oncolytics: FDA Type D meeting in Aug; half of REO 033 sites activated, >20 patients pre-identified
ONCOLYTICS BIOTECH INC
- 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.