On April 6, 2026, Oncolytics Biotech announced a Type C meeting with the U.S. Food and Drug Administration scheduled for April 16, 2026 to discuss a single‑arm pivotal study of pelareorep in combination with a checkpoint inhibitor for patients with squamous cell anal carcinoma who progressed after first‑line therapy.
The company plans to enroll 60‑70 patients and will use objective response rate as the primary endpoint. GOBLET Cohort 4 data showed a 30 % objective response rate and a median duration of response of 17 months, compared with 10‑14 % objective response rate and 9.5 months median duration in real‑world second‑line patients, underscoring the potential clinical benefit of the combination.
The meeting will focus on statistical design and sample size, with the goal of aligning on a registration pathway that could open a new indication for pelareorep. The anal cancer market is projected to double to $2.3 billion by 2035, making a successful registration a significant revenue opportunity for a company that is currently pre‑revenue and operating at negative free cash flow.
CEO Jared Kelly said, "We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer." He added, "Our goal is to align with the FDA on the statistical analysis plan and sample size for a potential pivotal single‑arm study in second‑line and later SCAC."
Oncolytics has also launched a $75 million at‑the‑market equity program with Jefferies to support ongoing clinical development and operations. Analysts have upgraded the stock to a "Moderate Buy" or "Strong Buy," while an AI‑driven analysis rates the stock as "Neutral" due to the company’s weak financial performance and ongoing cash burn.
The FDA meeting is a material regulatory milestone that could accelerate the company’s path to market for its intravenous oncolytic virus platform and expand its pipeline in a rare cancer with limited treatment options.
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