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) announced updated GOBLET Cohort 4 data in third-line metastatic squamous cell anal carcinoma on Jan 12, 2026. As of the data cut, 4 of 14 evaluable patients (≈29% ORR) achieved objective responses including 2 complete responses and 2 partial responses. Median duration of response is ~17 months (67 weeks). The company notes historical third-line ORRs are ≈10% or less and there are no FDA-approved therapies for third-line anal cancer. Oncolytics plans a Type C meeting with the FDA in Q1 2026 and says reproducible ORR/DOR in a registration study could support accelerated approval.
Oncolytics Biotech (Nasdaq: ONCY) announced a proposal to change its jurisdiction of incorporation from Alberta, Canada, to the State of Nevada to align corporate domicile with its predominantly U.S.-based operations, management, shareholders, and capital markets activity. Effective January 1, 2026 the company became a domestic issuer under SEC rules and lost foreign private issuer status. The domestication requires shareholder approval at a Special Meeting on January 15, 2026 for holders of record as of December 9, 2025. A Form F-4 registration statement (No. 333-290954) has been declared effective by the SEC.
Oncolytics (Nasdaq: ONCY) provided an update on its intellectual property strategy for pelareorep, reporting a Track 1 prioritized examination patent application filed in early Q3 2025 focused on manufacturing innovations. The company said initial USPTO written feedback was received in Q4 2025 and it expects a final action on the Track 1 application in Q3 2026. If allowed, claims from this application could potentially extend protection for pelareorep to 2044. Oncolytics also plans additional filings on manufacturing and method-of-use patents in 2026 to pursue further IP protection and support late-stage development, regulatory approvals, and future commercialization.
Oncolytics Biotech (Nasdaq: ONCY) expanded its Gastrointestinal Tumor Scientific Advisory Board with the appointments of Dr. Eileen O’Reilly, Dr. Neil Segal, and Dr. Van Morris to guide development of pelareorep across pancreatic, colorectal, and anal cancers.
The company cited aggregated clinical signals: ~22% two-year OS in first-line pancreatic versus ~9% historical, 30% ORR for pelareorep+checkpoint in anal cancer versus 13.8% benchmark, and KRAS-mutant mCRC improvements including 16.6 months PFS vs 5.7 months historical and 27.0 months OS vs 11.2 months. Oncolytics plans pivotal studies and ongoing FDA engagement.
Oncolytics Biotech (Nasdaq: ONCY) reported clinical and translational data supporting pelareorep in second-line KRAS-mutant, microsatellite-stable metastatic colorectal cancer (mCRC).
Key results: 33% objective response rate (ORR) in KRAS-mutant MSS patients versus historical 6–11% for bevacizumab+FOLFIRI, and reported >2x progression-free and overall survival versus bevacizumab+FOLFIRI. Translational analyses show increased KRAS-mutant–specific T cells. Company plans a sponsored controlled study to confirm findings.
Oncolytics Biotech (Nasdaq: ONCY) filed an amended Form F-4 that the SEC declared effective and rescheduled its special meeting to January 15, 2026 at 10:00 AM ET with a record date of December 9, 2025. Shareholders will vote on a Continuance from Alberta to British Columbia and a Domestication from Canada to the State of Nevada, expected on or around April 1, 2026.
The proposals require an affirmative vote of not less than two-thirds of votes cast. If approved, the company expects no material changes to operations or financial results, will remain subject to SEC reporting, and its common shares will continue to trade on Nasdaq under ONCY. Shareholders will also vote on a new incentive award plan. The Domestication is described as intended to reduce regulatory burden and cost and better align domicile with U.S.-based operations and shareholders.
Oncolytics Biotech (Nasdaq: ONCY) cancelled its previously scheduled Special Meeting of shareholders that had been set for December 15, 2025. The company said the meeting was postponed because of delays at the U.S. Securities and Exchange Commission caused by the recent federal government shutdown.
When rescheduled, the Special Meeting will include a vote on a proposed domestication that would change Oncolytics’ jurisdiction from the Province of Alberta, Canada to the State of Nevada, USA. The company intends to set a new meeting date as soon as practicable.
Oncolytics Biotech (Nasdaq: ONCY) announced FDA alignment on the Phase 3 pivotal study design for pelareorep in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
The trial will compare gemcitabine + nab-paclitaxel (GnP) alone versus GnP plus pelareorep, with an optional third arm adding a checkpoint inhibitor (CPI). The primary endpoint is overall survival; secondary endpoints include progression-free survival and objective response rate.
The study is statistically powered to show a clinically meaningful survival benefit, may include an interim analysis to support accelerated registration, and is planned to launch in the first half of 2026. The protocol permits flexible CPI selection; pelareorep has previously been combined with atezolizumab, pembrolizumab, nivolumab, and retifanlimab in gastrointestinal and other tumor types.
Oncolytics Biotech (Nasdaq: ONCY) announced formation of a Gastrointestinal Tumor Scientific Advisory Board to guide development of pelareorep for pancreatic, colorectal, and anal cancers.
Inaugural SAB members are Sanjay Goel, Deva Mahalingam, and Dirk Arnold, each with lead-investigator experience in pelareorep trials. The SAB will expand to six members and advise on registration-enabling study design and potential accelerated approval pathways.
Oncolytics Biotech (NASDAQ: ONCY) reported updated data from the GOBLET study SCAC cohort showing pelareorep plus atezolizumab achieved a 30% objective response rate (6/20 evaluable patients) in second-line or later squamous cell anal carcinoma versus a 13.8% historical benchmark. The median duration of response was 15.5 months versus 9.5 months for the current standard. Two complete responses were durable (one >2 years, one 15 months) and an additional response is ongoing at 64 weeks. The company plans FDA discussions on a single-arm accelerated approval study in Q1 2026 with study launch potential in H1 2026.