Oncolytics Biotech to meet FDA on registrational pathway for REO 033 colorectal cancer trial

PUBT · 1d ago
Oncolytics Biotech to meet FDA on registrational pathway for REO 033 colorectal cancer trial
  • Oncolytics Biotech will hold an FDA Type D meeting in the first half of August 2026 to discuss a registrational pathway for REO 033.
  • The plan adds a registration-directed Part B to REO 033, a randomized study in second-line RAS-mutant MSS metastatic colorectal cancer.
  • Part B is designed to support potential accelerated approval and traditional full approval within the same study, using blinded independent central review.
  • Initial tumor response data from Part A is expected by year-end 2026; Part B enrollment is targeted for the first quarter of 2027, subject to FDA feedback.


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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001129928-26-000043), on July 13, 2026, and is solely responsible for the information contained therein.