Regulatory Shift: The FDA's move to require only one clinical trial for new drug approvals signifies a dramatic shift in regulatory pathways, potentially accelerating oncology breakthroughs and enhancing market opportunities for biotech firms.
Promising Clinical Data: Oncolytics Biotech's pelareorep achieved a 33% objective response rate in KRAS-mutant metastatic colorectal cancer patients, significantly surpassing the historical benchmark of 6-11%, highlighting its potential in gastrointestinal tumors.
Expansive Market Potential: The total addressable market for pelareorep in colorectal cancer is projected to reach $20 billion by 2033, indicating that the drug could become a transformational treatment option addressing unmet medical needs.
Strategic Planning: Oncolytics plans to sponsor a controlled study in KRAS-mutant colorectal cancer following consultations with key opinion leaders and regulatory authorities, ensuring data control and transparency to support future regulatory submissions.
ONCY
$1.04+Infinity%1D
Analyst Views on ONCY
Wall Street analysts forecast ONCY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ONCY is 5.50 USD with a low forecast of 3.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
Wall Street analysts forecast ONCY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ONCY is 5.50 USD with a low forecast of 3.00 USD and a high forecast of 10.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Buy
1 Hold
0 Sell
Strong Buy
Current: 0.923
Low
3.00
Averages
5.50
High
10.00
Current: 0.923
Low
3.00
Averages
5.50
High
10.00
H.C. Wainwright
H.C. Wainwright
upgrade
$5 -> $10
2025-11-17
Reason
H.C. Wainwright
H.C. Wainwright
Price Target
$5 -> $10
2025-11-17
upgrade
Reason
H.C. Wainwright raised the firm's price target on Oncolytics to $10 from $5 and keeps a Buy rating on the shares. The firm says the company's "compelling" data in gastrointestinal tumors increase its confidence ahead of the FDA meeting. H.C. Wainwright is increasingly confident that pelareorep is advancing toward "actionable regulatory pathways" across three "high-value" cancer indications.
Lake Street
Chad Messer
initiated
$7
2025-08-13
Reason
Lake Street
Chad Messer
Price Target
$7
2025-08-13
initiated
Reason
Lake Street analyst Chad Messer initiated coverage of Oncolytics with a Buy rating and $7 price target. Oncolytics is emerging under new management with a clear pivotal strategy focused in frontline metastatic pancreatic ductal adenocarcinoma, where "existing clinical data is strong and the unmet need is clear," the analyst tells investors. Pelareorep has shown "impressive" increases in survival compared to both historical results and in a randomized study when added to standard of care regimens, added the analyst, who also notes that the FDA has granted fast track designation to pelareorep in pancreatic cancer.
JonesResearch
Soumit Roy
Buy
to
Hold
downgrade
2025-05-16
Reason
JonesResearch
Soumit Roy
Price Target
2025-05-16
downgrade
Buy
to
Hold
Reason
RBC Capital
Douglas Miehm
Buy
Maintains
$6 → $5
2025-03-10
Reason
RBC Capital
Douglas Miehm
Price Target
$6 → $5
2025-03-10
Maintains
Buy
Reason
RBC Capital lowered the firm's price target on Oncolytics to C$5 from C$6 and keeps an Outperform rating on the shares.
About ONCY
Oncolytics Biotech Inc. is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent that activates the innate and adaptive immune systems and weakens tumor defense mechanisms. This improves the ability of the immune system to fight cancer, making tumors more susceptible to a broad range of oncology treatments. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype, turning cold tumors hot through innate and adaptive immune responses to treat a variety of cancers. The Company is also advancing its programs in hormone receptor-positive / human epidermal growth factor 2-negative (HR+/ HER2-) advanced and metastatic breast cancer (mBC) and metastatic pancreatic ductal adenocarcinoma (PDAC) to registration-enabled clinical studies. In addition, it is exploring opportunities for registrational programs in other gastrointestinal cancers through its GOBLET platform study.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
