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 (ONCY) is a clinical-stage biotech company advancing pelareorep, an innovative oncolytic virus immunotherapy targeting multiple cancer types. This dedicated news hub provides investors and researchers with centralized access to corporate developments and scientific progress updates.
Track critical updates including clinical trial results, regulatory milestones, and strategic partnerships. Our curated collection features press releases spanning Phase 2 breast cancer studies, pancreatic cancer research advancements, and manufacturing capacity expansions. Regular updates ensure timely awareness of key developments in HR+/HER2- metastatic breast cancer trials and other high-priority programs.
Discover verified information on pelareorep's mechanism of action, trial design specifics, and intellectual property developments. The resource eliminates the need by aggregating essential updates from randomized controlled studies to manufacturing quality initiatives. Bookmark this page for efficient monitoring of Oncolytics' progress in transforming cancer treatment through viral immunotherapy approaches.
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.
Oncolytics Biotech (NASDAQ: ONCY) filed a Form F-4 registration statement including a preliminary management circular/prospectus and announced a Special Meeting of Shareholders to vote on a continuance from Alberta to British Columbia and a domestication from British Columbia to Nevada. The Domestication requires an affirmative vote of not less than two-thirds of votes cast and is expected to occur on January 1, 2026 or as soon as practicable thereafter.
The company said there are not expected to be material changes to operations or financial results, that it will continue SEC reporting and Nasdaq trading under ONCY, and that the move is intended to reduce regulatory burden and costs, aid capital raising, and reflect that most operations and shareholders are in the United States. Shareholders will also vote on a new incentive award plan.
Oncolytics Biotech (NASDAQ: ONCY) announced updates for its planned registration-directed clinical trial in first-line pancreatic ductal adenocarcinoma (PDAC). The company will meet with the FDA in mid-November 2025 to discuss study details.
The proposed trial features a three-arm design evaluating: 1) Gemcitabine + nab-paclitaxel (GnP) control, 2) GnP + pelareorep, and 3) GnP + pelareorep + checkpoint inhibitor. The study's primary endpoint is Overall Survival, with planned interim analysis for early efficacy assessment.
Previous post-hoc analysis showed pelareorep plus chemotherapy achieved 22% two-year survival rate compared to 9% with chemotherapy alone. The company aims to establish pelareorep as the first approved immunotherapy in first-line pancreatic cancer.
Oncolytics Biotech (NASDAQ:ONCY) reported progress updates on its GOBLET trial evaluating pelareorep for gastrointestinal cancers. In Cohort 4, studying second-line SCAC, the company achieved a 33% overall response rate in 12 patients, nearly tripling competitor results. Enrollment has reached 20 evaluable patients, with completion expected by end-2025.
For Cohort 5, investigating first-line mPDAC, enrollment is 40% complete, evaluating pelareorep with modified FOLFIRINOX with/without atezolizumab. The study is expanding to U.S. sites, including Northwestern University, pending protocol amendment approval.
Oncolytics Biotech (NASDAQ: ONCY) reported significant clinical and translational data from three metastatic colorectal cancer (mCRC) studies for its immunotherapy drug pelareorep. In the REO 022 trial, pelareorep combined with FOLFIRI and bevacizumab showed remarkable results in KRAS mutant patients, achieving 16.6 months median progression-free survival (versus 5.7 months standard) and 27.0 months median overall survival (versus 11.2 months standard).
The GOBLET study's 3L mCRC Cohort 3, combining pelareorep with atezolizumab and TAS-102, met its efficacy endpoint with improved survival rates. Translational data from REO 022 and REO 013 studies confirmed pelareorep's mechanism of action, demonstrating viral replication and immune activation in tumors. The company plans to advance regulatory discussions and develop an investigator-sponsored trial for KRAS mutant mCRC patients.
Oncolytics Biotech (NASDAQ: ONCY) has released updated safety data for its immunotherapy drug pelareorep, showcasing favorable results across multiple gastrointestinal cancers. The analysis encompasses over 1,200 total patients, including more than 300 gastrointestinal cancer patients across 8 clinical studies.
The data confirms pelareorep's consistent safety profile, with most adverse events being Grade 1 and 2, including fever, chills, fatigue, and gastrointestinal symptoms. The therapy has been tested in combination with various treatments, including modified FOLFIRINOX for metastatic pancreatic cancer, and in multiple tumor types such as colorectal and anal cancer.
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