Oncolytics says FDA aligns on pivotal expansion path for REO 033 colorectal cancer trial

• Oncolytics received FDA written feedback supporting a registrational path to expand its REO 033 colorectal cancer study into a pivotal Part B.
• Trial results have not been presented; a Part B decision will follow interim clinical data from the ongoing randomized Part A.
• The proposed pathway could support accelerated approval based on tumor response, with progression-free survival intended to support full approval.
• Management plans to start Part B preparation once Part A interim data are positive, aiming to shorten the timeline into a pivotal stage.
• Pelareorep combination therapy already holds FDA Fast Track designation in second-line RAS-mutant, MSS metastatic colorectal cancer.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Oncolytics Biotech Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202608180900PRIMZONECNPR____9811717) on August 18, 2026, and is solely responsible for the information contained therein.