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  5. Oncolytics Biotech Aligns with FDA on Pivotal Phase 3 Trial for Pancreatic Cancer

Oncolytics Biotech Aligns with FDA on Pivotal Phase 3 Trial for Pancreatic Cancer

Written by Emily J. Thompson, Senior Investment Analyst
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ONCY.O+1.12%
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VWAV.O-2.01%
Source: Globenewswire
Updated: 54 minutes ago
0mins
Intellectia AI SwingMax
Intellectia AI SwingMax
Source: Globenewswire
  • FDA Agreement: Oncolytics Biotech has aligned with the FDA to initiate a pivotal global trial involving 440 patients, combining its lead asset pelareorep with chemotherapy to enhance overall survival in pancreatic cancer, marking a significant advancement in the field of cancer immunotherapy.
  • Survival Rate Improvement: Phase 2 data indicated that pelareorep nearly doubled median overall survival, attracting partnerships with major pharmaceutical companies like Pfizer, Merck, and Roche, which underscores its potential in treating resistant populations and strengthens Oncolytics' market position.
  • Market Undervaluation: Despite a market capitalization below $150 million, Oncolytics is significantly undervalued compared to comparable oncology assets at this stage, reflecting a misunderstanding of trial risks; as enrollment progresses, this valuation gap is expected to narrow.
  • Industry Context: The pharmaceutical industry faces a patent cliff exceeding $250 billion from 2023 to 2030, and Oncolytics' innovative therapy offers a potential solution for extending the life of existing drug franchises, aligning with the industry's urgent need for new therapies.
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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: 0.981
sliders
Low
3.00
Averages
5.50
High
10.00
Current: 0.981
sliders
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.
See All Ratings
Financial AI Agent
Financial AI Agent
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
Preview
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.

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