Oncolytics gets FDA feedback on colorectal cancer trial expansion

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Go back to Oncolytics gets FDA feedback on colorectal cancer trial expansion

Oncolytics Biotech® Aligns with FDA on Registrational Path for Second-Line RAS-Mutant MSS Colorectal Cancer

August 18, 2026 9:00 AM EDT

FDA written feedback provides alignment on a potential pivotal Part B expansion of the ongoing REO 033 study

Proposed pathway offers potential accelerated approval based on objective response rate and progression-free survival supporting full approval

Pivotal expansion to follow initial clinical data from the ongoing randomized Part A

SAN DIEGO, Aug. 18, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (Oncolytics or the Company), a clinical-stage immunotherapy company developing pelareorep, today announced that it has received written... More