09:11 AM EDT, 07/29/2025 (MT Newswires) -- Oncolytics Biotech ( ONCY ) on Tuesday said it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) for a study assessing the company's lead compound, pelareorep, as a first-line therapy in metastatic pancreatic ductal adenocarcinoma (mPDAC), with overall survival as the primary endpoint.

Discussions with the FDA will focus on finalizing a clinical trial design that showcases pelareorep's synergy with chemotherapy with or without checkpoint inhibition, a statement said. The company will also consider proposing an adaptive study in collaboration with a third party as an option.

If successful, Oncolytics expects to launch study start-up activities before the end of this year, with Chief Executive Jared Kelly expecting to "move quickly and decisively down a clear regulatory path."

Oncolytics was last seen down US$0.02, to US$1.07 in New York pre-market trading.