Oncolytics reports FDA Type D meeting and rapid progress in randomized REO 033 colorectal cancer trial

Oncolytics reported FDA regulatory engagement and rapid enrollment progress for the randomized REO 033 trial, advancing a potential registrational pathway for pelareorep.

Key Highlights:

• Company to hold a Type D meeting with FDA in first half of August 2026 to discuss registrational design via addition of Part B.
• Part B would be a randomized, registration-directed expansion with blinded independent central review to support accelerated and full approval.
• Part A enrollment (n=60) progressing: ~half of planned sites to be activated by end of July and >20 patients pre-identified.
• Remaining sites expected active by end of August, positioning study for accelerated enrollment in H2 2026.
• Initial tumor response update from Part A expected by year-end 2026; Part B enrollment could begin Q1 2027, subject to FDA feedback.

Original SEC Filing:

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