Oncolytics Biotech Inc. (NASDAQ: ONCY) confirmed that the U.S. Food and Drug Administration has agreed on the design of the company’s Phase 3 pivotal trial for pelareorep in combination with gemcitabine plus nab‑paclitaxel for first‑line metastatic pancreatic ductal adenocarcinoma. The alignment was reached during a recent Type C meeting held shortly before the announcement.
The agreement clarifies key elements of the study protocol, including patient selection criteria, dosing schedule, and the primary endpoint of overall survival. The trial will enroll approximately 1,200 patients across 70 sites in the United States and Canada, with an interim analysis planned after 600 events to support a potential accelerated approval pathway.
The regulatory milestone removes a major hurdle in the development timeline and positions pelareorep as a candidate for the first approved immunotherapy in this indication, where current standard of care offers limited benefit. Oncolytics estimates that a successful trial could open a market worth more than $5 billion in the United States alone.
Oncolytics reported that it holds $12.4 million in cash and cash equivalents as of September 30 2025, sufficient to fund the pivotal study through the first quarter of 2026. The company’s market capitalization was $109.3 million on November 19, 2025, and it has maintained a “Buy” rating from H.C. Wainwright, which recently doubled its price target to $10.00 following the company’s Q3 2025 financial results.
CEO Jared Kelly said the FDA alignment “provides the regulatory clarity needed to move pelareorep forward and could bring the first approved immunotherapy to patients with metastatic pancreatic cancer.” Chief Medical Officer Dr. Thomas Heineman added that the study design aligns with the company’s long‑term strategy to combine pelareorep with checkpoint inhibitors in future trials.
Analysts note that the alignment signals confidence in pelareorep’s clinical data, which showed a 12‑month overall survival benefit in a phase 2 study of 120 patients. The company’s next milestone will be the initiation of the pivotal trial in the first half of 2026, with enrollment expected to begin in March.
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