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, Inc. (Nasdaq: ONCY) is a clinical-stage biotechnology company whose news flow centers on the development of pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Company updates frequently highlight clinical data in metastatic pancreatic cancer, metastatic breast cancer, and gastrointestinal tumors such as anal and colorectal cancers, where pelareorep is being evaluated in combination with chemotherapy and checkpoint inhibitors.
News releases from Oncolytics often cover clinical trial milestones, including results from the GOBLET study in squamous cell anal carcinoma and colorectal cancer, as well as alignment with the U.S. Food and Drug Administration on pivotal trial designs in first-line metastatic pancreatic ductal adenocarcinoma. Investors can also expect announcements about planned registration-directed studies, accelerated approval strategies in indications with no FDA-approved therapies, and translational findings such as tumor-specific T-cell responses in KRAS-mutant metastatic colorectal cancer.
Oncolytics’ news also addresses corporate and regulatory developments, including its proposal to change its jurisdiction of incorporation from Alberta, Canada, to the State of Nevada, its transition to domestic issuer status under SEC rules, and capital markets activities such as at-the-market equity programs. Additional updates describe expansions of the company’s Gastrointestinal Tumor Scientific Advisory Board and appointments of senior leaders in strategy, operations, and biostatistics to support late-stage clinical execution.
This ONCY news page aggregates these press releases and related coverage so readers can follow key developments in pelareorep’s clinical progress, regulatory interactions, intellectual property initiatives, and corporate strategy. It is a useful resource for tracking how new data, advisory board input, and structural changes may influence the company’s oncology pipeline over time.
Oncolytics (Nasdaq: ONCY) announced the FDA granted Fast Track Designation for pelareorep plus bevacizumab and FOLFIRI in 2L KRAS‑mutant MSS metastatic colorectal cancer. Clinical signals cited include a 33% ORR, median PFS 16.6 months and median OS 27 months, versus SOC benchmarks of ~10% ORR, 5.7‑month PFS and 11.2‑month OS. The company plans a controlled 2L study, first site activation in March, up to 11 sites, with interim data expected by year‑end 2026. The Fast Track may enable more FDA engagement and possible accelerated pathways.
Oncolytics (Nasdaq: ONCY) announced on Jan 14, 2026 the appointments of John McAdory as Executive Vice President, Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics to support late‑stage, registration‑directed development of pelareorep in pancreatic, colorectal, and anal cancers.
The company granted inducement awards: McAdory — 500,000 stock options (exercise price $0.97) plus 300,000 restricted share units that vest on a material transaction; Wu — 300,000 stock options (exercise price $0.97). Options vest 50% at one year, then 25% annually.
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.