(RTTNews) – Oncolytics Biotech Inc. (ONCY), a clinical-stage immunotherapy company, announced that the U.S. Food and Drug Administration or FDA has granted Fast Track designation to Pelareorep in combination with a checkpoint inhibitor in second-Line and later Anal Cancer.
The designation covers patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) whose disease progressed on, or who were intolerant to, prior systemic therapy.
Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy.
The fast track designation now provides Oncolytics opportunities for more frequent interactions with the FDA throughout development, rolling review of a future Biologics License Application, and eligibility for Priority Review, if applicable.
Notably, the current Fast Track designation in SCAC is the third gastrointestinal cancer designation granted to pelareorep by the FDA, following designations in KRAS-mutated metastatic colorectal cancer in February 2026 and pancreatic cancer in late 2022.
The designation follows the positive feedback received during Oncolytics’ April 2026 meeting with the FDA regarding a potential registrational development strategy for the program.
Based on the FDA’s feedback, Oncolytics believes it has a clear regulatory framework in place to advance Pelareorep toward a pivotal study in this indication.
According to the company, previously reported clinical results of Pelareorep demonstrated an objective response rate of approximately 30%, more than double historical response rates reported in this setting, a median duration of response of approximately 15.5 months versus 9.5 months, and a 12-month overall survival rate of 82% compared to 45.7%.
The company estimates this advanced SCAC indication as a U.S. commercial opportunity approaching $1 billion annually.
Financial and Stock Performance
As of March 31, 2026, the company had cash and cash equivalents of $5.49 million.
Meanwhile, in its first-quarter results, the company said its current cash resources are sufficient to fund near-term operations but not enough to support operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern.
ONCY has traded between $0.77 and $1.51 over the last year. The stock closed Monday’s trade at 0.85, down 0.39%.
In after-hours trading, ONCY is down 2.28% at $0.83.
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