Oncolytics Biotech Shares Rise on Plans for FDA Meeting to Expedite Cancer Drug Trial

Shares of Oncolytics Biotech Inc. (NASDAQ:ONCY) rose in premarket trading Monday after the company announced plans for a meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential registrational pathway for its cancer therapy, pelareorep.

FDA Meeting to Define Pathway

Oncolytics Biotech said it will hold a Type D meeting with the FDA in the first half of August. The discussion will focus on a proposal to add a second part, Part B, to its ongoing REO 033 clinical trial for its investigational immunotherapy.

The proposed Part B is designed as a randomized study intended to support potential accelerated and full approval of pelareorep. The therapy is being evaluated for the treatment of RAS-mutant, microsatellite stable (MSS) metastatic colorectal cancer.

Trial Design and Timeline

The company stated that this approach would preserve the core design of the REO 033 trial while increasing patient enrollment and incorporating a blinded independent central review. By modifying the existing study, Oncolytics aims to generate early randomized efficacy data from the trial's first part while positioning Part B as a registrational study, potentially avoiding the need for a separate, later-stage trial.

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Progress on Part A of the study, which targets 60 patients, continues, with half of the clinical sites expected to be activated by the end of July. The company expects to report an initial tumor response update from Part A by the end of 2026 and, subject to FDA feedback, initiate enrollment for Part B during the first quarter of 2027.

Market Impact and Background

Following the announcement, shares of Oncolytics Biotech gained 5.9% in premarket trading. A positive outcome from the FDA meeting could represent a significant de-risking event and a more efficient path to market for the company's lead asset.

The REO 033 trial evaluates pelareorep in combination with FOLFIRI and bevacizumab for the second-line treatment of patients. Based on data from a previous study, pelareorep has already received a Fast Track designation from the FDA for this indication, a status intended to expedite the review of drugs for serious conditions.