Oncolytics Biotech shares rise 18.48% premarket after FDA grants Fast Track for pelareorep in 2L KRAS-mutant MSS mCRC with 33% ORR, 16.6-month PFS, 27-month OS.

Oncolytics Biotech Inc. surged 18.48% in premarket trading following the FDA’s Fast Track Designation for pelareorep in second-line KRAS-mutant MSS metastatic colorectal cancer. The designation, announced February 4, 2026, underscores the therapy’s robust clinical data: a 33% objective response rate (vs. 10% standard care), 16.6-month progression-free survival (vs. 5.7 months), and 27-month overall survival (vs. 11.2 months). The FDA’s recognition accelerates regulatory engagement and potential expedited pathways, validating pelareorep’s role as a platform immunotherapy for gastrointestinal cancers. CEO Jared Kelly highlighted the therapy’s tripling of key endpoints in a $3–5 billion annual market segment, with a controlled study launching in March 2026 and interim data expected by year-end. The news aligns with the stock’s sharp premarket rise, driven by optimism over regulatory momentum and market potential.