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) 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.
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.