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) completed its domestication from Alberta, Canada to Nevada, United States, effective March 31, 2026.
The change was approved by shareholders on January 15, 2026; the company continued to British Columbia on March 17, 2026, will keep a Calgary office, and made San Diego its new headquarters. Common stock remains on Nasdaq as ONCY; new CUSIP is 68237V 103 and ISIN is US68237V1035. According to the company, the move aims to improve operational efficiency, streamline regulatory structure, and enhance access to U.S. capital markets.
Oncolytics (NASDAQ: ONCY) announced two AACR 2026 presentations reporting translational and mechanistic data for pelareorep as a systemic immune-priming backbone.
Key findings: a 62% objective response rate in first-line metastatic pancreatic ductal adenocarcinoma with pelareorep plus atezolizumab and chemotherapy, a median PFS of 7.5 vs. 5.6 months in patients with immune activation signatures, evidence of tertiary lymphoid structure formation in early breast cancer biopsies, and stimulation of RAS-specific T-cell clones in GI cancers.
Oncolytics Biotech (Nasdaq: ONCY) launched a randomized Phase 2 study (REO 033) testing pelareorep plus bevacizumab and FOLFIRI versus bevacizumab and FOLFIRI in 2L RAS‑mutant, MSS metastatic colorectal cancer. Each arm is planned to enroll 30 patients; primary endpoint is objective response rate, with preliminary data expected by year‑end 2026.
Prior REO 022 results reported median OS 27 months, median PFS 16.6 months, and ORR 33% versus ~11.2, 5.7 months, and ~10% for standard therapy; pelareorep combo has FDA Fast Track Designation.
Oncolytics (Nasdaq: ONCY) will prioritize registrational development of pelareorep in squamous cell anal cancer (SCAC) and metastatic colorectal cancer (CRC) after concluding GOBLET enrollment. The company plans an FDA meeting in mid-April to align on a single‑arm SCAC registrational study, believes a trial well under 100 subjects could support approval, and has sufficient cash to avoid immediate material dilution.
Oncolytics stopped further enrollment in GOBLET Cohort 5 PDAC arms at approximately 20 patients per arm and will continue to follow enrolled patients for mature results.
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.