Welcome to our dedicated page for Oncolytics Biotech news (Ticker: ONCY), a resource for investors and traders seeking the latest updates and insights on Oncolytics Biotech stock.
Oncolytics Biotech develops pelareorep, an investigational systemically delivered immunotherapy for cancer that has been shown to activate innate immune-sensing pathways. Company news centers on pelareorep clinical and translational data, FDA interactions, and study activity across gastrointestinal and other solid tumor indications, including metastatic colorectal cancer, squamous cell anal carcinoma, pancreatic cancer, and breast cancer.
Recurring updates also cover the company's registration-focused development priorities, Fast Track Designation for pelareorep-based treatment in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, scientific meeting presentations, financing arrangements, and its completed change of jurisdiction to Nevada while ONCY common stock continues to trade on Nasdaq.
Oncolytics Biotech (Nasdaq: ONCY) received U.S. FDA Fast Track designation for pelareorep in combination with a checkpoint inhibitor to treat patients with inoperable, locally recurrent or metastatic squamous cell carcinoma of the anal canal who have progressed on or were intolerant to one or more prior systemic therapies.
The designation, which can enable more frequent FDA interactions, rolling BLA review and potential Priority Review, supports advancement toward a pivotal study. It is Oncolytics’ third Fast Track in gastrointestinal cancers, following KRAS‑mutated metastatic colorectal cancer and pancreatic cancer, in an estimated U.S. market approaching $1 billion annually with no FDA‑approved options after current first‑line standard of care.
Fast Track was supported by GOBLET study data in advanced anal cancer showing an objective response rate of ~30%, longer median duration of response (15.5 vs. 9.5 months) and higher 12‑month overall survival (82% vs. 45.7%) versus historical benchmarks.
Oncolytics Biotech (Nasdaq: ONCY) reported clinical and regulatory progress for REO 033, its randomized study of pelareorep plus FOLFIRI and bevacizumab in second-line RAS-mutant MSS metastatic colorectal cancer. REO 033 builds on REO 022, where pelareorep more than doubled historical benchmarks across several efficacy measures and subsequently received FDA Fast Track designation for this indication.
According to the company, Part A of REO 033 (n=60) is advancing, with about half of planned sites to be activated by end of July and remaining sites expected by end of August 2026; more than 20 patients have been pre-identified. Oncolytics plans a Type D FDA meeting in the first half of August 2026 to discuss adding a registration-directed Part B that would increase enrollment and add blinded independent central review, aiming to support both potential accelerated and traditional approval within the same study. The company expects initial tumor response data from Part A by year-end 2026 and, subject to FDA feedback, plans to begin enrollment in Part B in the first quarter of 2027.
Oncolytics Biotech (Nasdaq: ONCY) received a new U.S. patent covering key aspects of its proprietary process for manufacturing pelareorep, an investigational immunotherapy. The patent is expected to protect commercial-scale manufacturing into 2044.
A previously filed method-of-use patent application could extend pelareorep protection into 2046 if issued, and further filings are planned in 2026 to broaden its intellectual property across additional oncology applications and combinations.
Oncolytics Biotech (Nasdaq: ONCY) announced key leadership changes on June 2, 2026. Steve Glover has joined the Board of Directors, bringing public company leadership and transaction experience, including chairing Ambrx Biopharma during its approximately $2 billion acquisition by Johnson & Johnson.
Oncolytics also promoted John McAdory to Chief Operating Officer. According to Oncolytics, McAdory will oversee clinical operations and development, preclinical R&D, and support strategic partnerships and business development as the company advances pelareorep and its immunotherapy platform.
Oncolytics Biotech (Nasdaq: ONCY) reported initial preclinical data showing pelareorep combined with RAS inhibitor modalities achieved greater anti-tumor activity than either approach alone in a solid tumor model.
The company plans further studies in pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), with full results expected in late 2026.
Oncolytics Biotech (ONCY) highlights pelareorep as an immune‑priming backbone rather than a standalone cancer drug. Survival signals include median overall survival of 27 months in metastatic colorectal cancer versus ~11.2 months historically, and landmark anal cancer survival of 82% vs 45.7% with standard care. CEO Jared Kelly, who helped drive Ambrx’s sale to Johnson & Johnson, focuses on positioning pelareorep as a scalable combination partner attractive to large pharma.
Oncolytics Biotech (Nasdaq: ONCY) will present new translational data on its investigational immunotherapy pelareorep at ASCO 2026 in Chicago, May 29–June 2, 2026.
Data from GOBLET (pancreatic cancer) and AWARE-1 (breast cancer) describe multi-step immune activation, TIL expansion, and responses in difficult-to-treat, KRAS-driven tumors.
Oncolytics (Nasdaq: ONCY) reported new REO 022 data showing a 19.5-month median duration of response for pelareorep-based therapy in second-line RAS-mutant, MSS metastatic colorectal cancer (mCRC), versus historical benchmarks of ~4–6 months. The combination produced a 33% objective response rate. The company is enrolling a randomized Phase 2 and is engaging the FDA on a potential accelerated approval pathway based on durability and time-to-event endpoints.
Oncolytics (Nasdaq: ONCY) announced FDA alignment on a pivotal, randomized controlled trial of pelareorep in unresectable metastatic squamous cell carcinoma of the anal canal (SCAC) on April 27, 2026. The trial is intended to support both accelerated and full approval within a single study framework.
Key clinical signals cited include a combination study in second-line+ SCAC showing median duration of response 15.5 months vs 9.5 months and 12-month survival 82% vs 45.7% versus current standard of care. Final protocol will incorporate FDA feedback.
Oncolytics (Nasdaq: ONCY) scheduled a Type C meeting with the FDA on April 16, 2026 to discuss a potential single-arm registrational pathway for pelareorep in second-line and later squamous cell anal carcinoma (SCAC).
The company intends to propose a pivotal single-arm study enrolling ~60–70 patients with objective response rate (ORR) as the primary endpoint; prior Cohort 4 data showed ~30% ORR and median duration of response of 17 months.