Oncolytics Biotech announced alignment with the FDA on the pivotal Phase III trial design of pelareorep combined with standard‑of‑care therapy for first‑line metastatic pancreatic ductal adenocarcinoma (mPDAC). The Type C meeting outcome clarifies primary and secondary endpoints and statistical plans required for potential registration. FDA concurrence on pivotal design reduces regulatory risk and gives Oncolytics a defined pathway to seek approval in a high‑unmet‑need indication where immunotherapy has had limited success. The company plans to proceed toward enrollment under the agreed protocol.