Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
ONCY Catalyst Timeline
Dated clinical, regulatory and corporate events for Oncolytics Biotech Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Oncolytics Biotech Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How ONCY actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-05-30 | pelareorep | Phase 1/2 data readout | Phase 1/2 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| REOLYSIN Monoclonal antibodyCompletedNCT00753038 | Carcinoma, Squamous Cell of the Head and Neck | Phase 3 | COMPLETED | 181 | May 1, 2013 |
Clinical Trial Results
Readouts, endpoints and source filings for every ONCY program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| pelareorep Fast TrackAcceleratedOrphan | unresectable metastatic squamous cell carcinoma of the anal canal | 2026-04-27 | median duration of response of 15.5 months versus 9.5 months; 12-month survival of 82% versus 45.7%Read More | Oncolytics Aligns with FDA on Planned Pivotal Anal Cancer StudyRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Kelly JaredDirector, Officer (Chief Executive Officer) | Buy | 5,050 114,050 held | $0.96 | 03/12/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in ONCY
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in ONCY for Q2 2026. | ||||
ONCY Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How ONCY ranks across every disease it competes in
ONCY News
Oncolytics Biotech® Announces Publication Demonstrating Pelareorep Creates Immune Responses in Liver Cancer That Make Tumors Susceptible to Immunotherapy
Oncolytics Biotech announced the publication of data demonstrating that pelareorep can transform the immunologically inactive microenvironment of liver cancer into an active one, making it more susceptible to immunotherapy. The findings suggest that pelareorep enhances the efficacy of existing cancer treatments, although liver cancer is not a current focus for the company. The publication highlights significant immune response changes, including increased CD8+ T cell infiltration.
Read more →Oncolytics Biotech® Reports Accelerating Enrollment in Randomized REO 033 RAS-Mutant, MSS Colorectal Cancer Study
Oncolytics Biotech has reported significant progress in its REO 033 study for RAS-mutant, MSS colorectal cancer, with nearly all clinical sites activated and patients enrolled. The company anticipates providing an interim update by year-end 2026, focusing on the efficacy of pelareorep combined with standard treatments. The FDA has aligned with Oncolytics on a potential path for accelerated approval based on positive clinical outcomes.
Read more →Oncolytics Biotech® Announces Positive Preclinical Results Combining Pelareorep with a Pan-RAS Inhibitor in Colorectal Cancer
Oncolytics Biotech announced positive preclinical results for pelareorep in combination with a pan-RAS inhibitor in colorectal cancer. The study showed that both therapies reduced tumor growth, with the combination yielding the best results. These findings suggest that pelareorep could enhance the effectiveness of RAS-targeted therapies and help delay resistance. Further evaluations are planned to optimize dosing and assess the therapy's impact on tumor response.
Read more →Oncolytics Biotech® Aligns with FDA on Registrational Path for Second-Line RAS-Mutant MSS Colorectal Cancer
Oncolytics Biotech has received positive feedback from the FDA regarding its REO 033 study for second-line RAS-mutant MSS colorectal cancer. The FDA's guidance supports a potential pivotal Part B expansion based on initial clinical data. The company aims for accelerated approval using objective response rates and progression-free survival metrics. Oncolytics plans to initiate Part B activities following positive interim results from Part A.
Read more →Oncolytics Biotech® Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal Cancer
Oncolytics Biotech has received Fast Track designation from the FDA for pelareorep, aimed at treating patients with advanced squamous cell carcinoma of the anal canal. This designation allows for expedited development and review, addressing a significant unmet medical need in a market estimated at $1 billion. The company has demonstrated promising clinical results, including a 30% objective response rate in prior studies.
Read more →Oncolytics Biotech® Reports FDA Regulatory Milestone and Strong Clinical Progress in Randomized RAS-Mutant MSS Colorectal Cancer Trial
Oncolytics Biotech has reported significant progress in its REO 033 trial for RAS-mutant MSS colorectal cancer, with half of the planned clinical sites set to activate this month. The company plans to hold a Type D meeting with the FDA to discuss a potential registrational pathway for the trial. The study aims to validate previous encouraging results and has received Fast Track designation from the FDA.
Read more →Oncolytics Biotech® Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044
Oncolytics Biotech has secured a new U.S. patent protecting the manufacturing process of its investigational immunotherapy, pelareorep, until 2044. This patent enhances the company's intellectual property portfolio and supports the commercial production of pelareorep. Additionally, a method-of-use patent application is under review, potentially extending protection to 2046. Oncolytics plans further patent filings to broaden its intellectual property estate.
Read more →Oncolytics Biotech® Announces Appointment of Steve Glover to Board of Directors and Promotion of John McAdory to Chief Operating Officer
Oncolytics Biotech has appointed Steve Glover to its Board of Directors and promoted John McAdory to Chief Operating Officer. Glover brings extensive experience from his previous role at Ambrx Biopharma, while McAdory will oversee clinical operations and development. The company is focused on advancing its investigational immunotherapy, pelareorep, which shows promise in treating various cancers.
Read more →Oncolytics Biotech Announces Positive Initial Preclinical Findings Supporting Further Evaluation of Pelareorep in Combination with RAS-Targeted Approaches
Oncolytics Biotech has announced positive initial preclinical findings regarding pelareorep, showing enhanced anti-tumor activity when combined with RAS inhibitors. The company plans to continue research on these combinations, particularly in pancreatic ductal adenocarcinoma and colorectal cancer models. CEO Jared Kelly highlighted the potential of pelareorep to improve treatment efficacy against RAS-mutated tumors that are notoriously challenging to treat due to immune resistance. Full results are expected to be released later in 2026.
Read more →Oncolytics Biotech® to Present Data at ASCO 2026 Reinforcing Pelareorep’s Potential Across Gastrointestinal Tumors
Oncolytics Biotech announced that it will present data on pelareorep at the 2026 ASCO Annual Meeting. The data from the GOBLET and AWARE-1 trials indicate that pelareorep enhances immune responses in gastrointestinal tumors. The findings suggest that pelareorep may effectively expand tumor-reactive immune cells, potentially improving treatment options for challenging cancers.
Read more →Oncolytics Biotech® Reports Durable Responses in Second-Line RAS-Mutant MSS Colorectal Cancer
Oncolytics Biotech has reported promising results for its investigational therapy, pelareorep, in patients with second-line RAS-mutant MSS metastatic colorectal cancer. The therapy demonstrated a median duration of response of 19.5 months, significantly exceeding historical benchmarks. The company is engaging with the FDA to explore an accelerated approval pathway based on these findings.
Read more →Oncolytics Aligns with FDA on Planned Pivotal Anal Cancer Study
Oncolytics Biotech has announced alignment with the FDA on a pivotal clinical study for pelareorep, aimed at treating unresectable metastatic squamous cell carcinoma of the anal canal. The study will focus on patients with no FDA-approved therapies and aims to support both accelerated and full approval. The company plans to incorporate FDA feedback into the final protocol, emphasizing the need for new treatment options in this area.
Read more →Oncolytics Biotech® Announces Type C FDA Meeting to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer
Oncolytics Biotech has announced a Type C meeting with the FDA to discuss a registrational pathway for pelareorep in anal cancer. The focus will be on initiating a pivotal study evaluating pelareorep in combination with a checkpoint inhibitor for patients with squamous cell anal carcinoma. Encouraging clinical activity has been observed, with a notable objective response rate in previous studies.
Read more →Oncolytics Biotech® Completes Domicile Change to the United States
Oncolytics Biotech has successfully changed its jurisdiction of incorporation from Alberta, Canada, to Nevada, USA. This transition, approved by shareholders, is expected to enhance operational efficiency and access to U.S. capital markets. The company will maintain its Calgary office while establishing a new headquarters in San Diego. The change reflects Oncolytics' status as a U.S. domestic issuer.
Read more →Oncolytics Biotech to Present New Mechanistic and Translational Data Supporting Pelareorep as an Immune-Priming Backbone at AACR 2026
Oncolytics Biotech Inc. announced that two abstracts related to its investigational immunotherapy pelareorep were accepted for presentation at the AACR Annual Meeting 2026. Pelareorep has shown promising results in activating immune responses in various cancers, particularly those driven by RAS mutations. Key data indicate that pelareorep could significantly enhance the effectiveness of immunotherapy and targeted therapies. The company aims to advance its clinical programs to address significant unmet needs in oncology, including pancreatic cancer.
Read more →Oncolytics Biotech® Launches Randomized Colorectal Cancer Study
Oncolytics Biotech has launched a Phase 2 study, REO 033, for metastatic colorectal cancer using pelareorep. The trial will compare the efficacy of pelareorep combined with standard treatments against a control arm. Preliminary data is expected by the end of 2026, following promising results from earlier studies.
Read more →Immuno-Oncology Investments Accelerate as Pipeline Catalysts Multiply in 2026
Oncolytics Biotech is advancing its registrational programs in anal and colorectal cancer, with promising data from the GOBLET study. The company plans to meet with the FDA to align on study design for approval. The immuno-oncology market is projected to grow significantly, with Oncolytics positioned to capitalize on this expansion through its innovative therapies.
Read more →Oncolytics Biotech® to Prioritize Registration-Focused Programs in Anal and Colorectal Cancer
Oncolytics Biotech has concluded enrollment in the GOBLET study and will now prioritize registration-focused programs in squamous cell anal cancer and metastatic colorectal cancer. The company believes it has sufficient data to pursue regulatory approval efficiently. A meeting with the FDA is planned for mid-April to discuss the design of a registrational study.
Read more →Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer
Oncolytics Biotech has received FDA Fast Track Designation for pelareorep in combination with bevacizumab and FOLFIRI for treating KRAS-mutant MSS metastatic colorectal cancer. Clinical data shows a 33% objective response rate and improved survival metrics compared to standard-of-care. The company plans to initiate a controlled study with interim data expected by the end of 2026.
Read more →The $71 Billion Cancer Shift: Why The FDA Is Speeding Up
Oncolytics Biotech has received Fast Track Designation from the FDA for its cancer treatment pelareorep, which demonstrates significant survival benefits in KRAS-mutant colorectal cancer patients. The treatment achieved a 33% response rate and improved median survival to 27 months compared to 11.2 months with standard chemotherapy. The company plans to launch a controlled study to further evaluate pelareorep's efficacy.
Read more →