Oncolytics Biotech Receives FDA Fast Track Designation for KRAS Mutant Colorectal Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4d ago
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Should l Buy ONCY?
Oncolytics Biotech announced that the U.S. Food and Drug Administration has granted Fast Track Designation to pelareorep in combination with bevacizumab and leucovorin, fluorouracil, irinotecan for the treatment of patients with KRAS mutant, microsatellite-stable metastatic colorectal cancer in the second-line setting. As part of the Company's increased focus on gastrointestinal cancer and analysis of the existing colorectal data set in the fall, the Company applied for and has now received Fast Track Designation. The Fast Track Designation is supported by clinical data demonstrating a 33% objective response rate for pelareorep-based therapy compared to approximately 10% ORR with standard-of-care in this patient population. In addition, pelareorep combination therapy was associated with a median progression-free survival of 16.6 months, compared to 5.7 months with SOC, and a median overall survival of 27 months, compared to 11.2 months with SOC. Oncolytics expects to initiate a controlled clinical study in second-line KRAS-mutant MSS mCRC comparing standard-of-care therapy alone versus standard-of-care plus pelareorep. The first clinical site is expected to be activated in March, with up to 10 additional sites anticipated to open shortly thereafter. Interim data from the study are expected by year-end. Further details regarding the study design and milestones are forthcoming.
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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
5 Buy
1 Hold
0 Sell
Strong Buy
Current: 0.837
Low
3.00
Averages
5.50
High
10.00
Current: 0.837
Low
3.00
Averages
5.50
High
10.00
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.
Oncolytics Biotech Receives FDA Fast Track Designation
- FDA Fast Track Designation: Oncolytics Biotech's cancer treatment pelareorep has received Fast Track Designation from the FDA for KRAS-mutant microsatellite-stable metastatic colorectal cancer, which is expected to expedite the approval process and enhance market competitiveness.
- Clinical Data Advantage: The 33% response rate of pelareorep combined with standard chemotherapy significantly surpasses the 10% rate of chemotherapy alone, with a median survival of 27 months, indicating its potential value in hard-to-treat cancer populations.
- Significant Market Opportunity: The annual revenue for second-line treatment of KRAS-mutant colorectal cancer ranges between $3 billion and $5 billion, positioning Oncolytics' innovative therapy to capture a substantial share in this rapidly growing market.
- Team Expansion and Strategic Positioning: Oncolytics Biotech has recently appointed two executives to support its expansion plans, demonstrating the company's commitment to future clinical trials and market outreach, thereby strengthening its leadership position in the biotech sector.
See More
Precision Biologics Market Awakens to $71 Billion Opportunity
- FDA Acceleration: Oncolytics Biotech's cancer treatment pelareorep has received Fast Track Designation from the FDA for KRAS-mutant microsatellite-stable metastatic colorectal cancer patients, demonstrating a 33% response rate significantly higher than the 10% seen with traditional chemotherapy, which will expedite its approval process and enhance market competitiveness.
- Survival Extension: Clinical data shows that patients treated with pelareorep have a median survival of 27 months compared to 11.2 months with standard treatment, indicating the drug's potential market value in hard-to-treat cancer populations, with the global second-line treatment market estimated between $3 billion and $5 billion annually.
- Leadership Team Expansion: Oncolytics Biotech recently appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President of Biostatistics to manage expanding clinical programs, reflecting the company's commitment to future growth and readiness.
- Clinical Trial Plans: The company plans to launch a controlled study in March 2026 comparing standard treatment with pelareorep, with interim data expected by year-end, further validating its efficacy in colorectal cancer treatment.
See More
FDA Accelerates Oncology Drug Approvals, Boosting Market Potential
- Regulatory Acceleration: In 2025, the FDA approved over 50 oncology drugs, with a notable shift towards targeted therapies for high-unmet-need solid tumors in 2026, projecting a market opportunity of $326.82 billion by 2031, indicating robust commercial potential.
- Fast Track Designation: Oncolytics Biotech's pelareorep received FDA Fast Track Designation for KRAS-mutant colorectal cancer, showing a 33% response rate when combined with standard chemotherapy, significantly higher than the 10% with chemotherapy alone, which will expedite its approval process.
- Clinical Trial Plans: Oncolytics plans to launch a controlled study comparing pelareorep with standard care in March 2026, with interim data expected by year-end, providing crucial clinical evidence in a competitive market.
- Team Expansion: Oncolytics Biotech recently appointed two key executives to enhance its strategic and operational capabilities, supporting its expanding R&D projects, reflecting the company's confidence and preparedness for future growth.
See More
Precision Biologics Market Awakens to $71 Billion Opportunity
- FDA Acceleration: Oncolytics Biotech's cancer treatment pelareorep has received Fast Track Designation from the FDA for KRAS-mutant microsatellite-stable metastatic colorectal cancer patients, demonstrating a 33% response rate, significantly higher than the 10% achieved with traditional chemotherapy, which will expedite its market entry and enhance the company's position in the competitive biopharmaceutical sector.
- Significant Survival Extension: Clinical data shows that patients treated with pelareorep have a median survival of 27 months compared to 11.2 months with standard treatment, indicating the drug's potential market value in hard-to-treat cancer populations, with the global second-line treatment market estimated between $3 billion and $5 billion annually.
- Clinical Trial Plans: Oncolytics plans to launch a controlled study in March 2026 comparing standard care versus standard care plus pelareorep, with interim data expected by year-end, laying the groundwork for future product line expansion.
- Leadership Team Expansion: Oncolytics Biotech has recently appointed two key executives to oversee strategy and biostatistics, aiming to strengthen the company's leadership in the rapidly evolving biopharmaceutical landscape to meet the increasing demands of clinical trials.
See More
Oncolytics Biotech Receives FDA Fast Track Designation for Pelareorep
- FDA Fast Track Designation: Oncolytics Biotech announced that its drug pelareorep has received Fast Track designation from the US FDA for second-line metastatic colorectal cancer, specifically targeting KRAS-mutant MSS colorectal cancer, which is expected to expedite its clinical development process.
- Significant Efficacy Data: Clinical data shows that patients receiving pelareorep combination therapy have an objective response rate of 33%, compared to approximately 10% with standard-of-care, indicating a substantial efficacy difference that could change treatment standards.
- Survival Improvement: The median progression-free survival for pelareorep combination treatment is 16.6 months, compared to 5.7 months for standard care, and the median overall survival is 27 months versus 11.2 months for standard care, highlighting its potential in extending patient survival.
- Future Clinical Trial Plans: Oncolytics plans to soon initiate a controlled trial comparing pelareorep combination therapy to standard care alone, further validating its application prospects in KRAS-mutant MSS colorectal cancer patients.
See More
Oncolytics Receives FDA Fast Track Designation for Pelareorep
- Impressive Clinical Data: Oncolytics' pelareorep demonstrates a 33% objective response rate in KRAS-mutant microsatellite-stable metastatic colorectal cancer patients, significantly surpassing the 10% response rate of standard treatment, indicating its potential in difficult-to-treat populations.
- Significant Survival Extension: The therapy achieves a median progression-free survival of 16.6 months compared to 5.7 months with standard care, and a median overall survival of 27 months versus 11.2 months, highlighting its strategic importance in improving patient outcomes.
- Substantial Market Potential: With approximately 2 million new colorectal cancer cases globally each year, the addressable market for second-line KRAS-mutant MSS mCRC is estimated to be between $3 billion and $5 billion, positioning Oncolytics' product for significant market impact.
- Clinical Trial Plans: The company plans to initiate a clinical trial comparing standard treatment with pelareorep by the end of 2026, with up to 10 clinical sites expected to participate, further validating its clinical efficacy and facilitating market entry.
See More
Oncolytics Biotech Receives FDA Fast Track Designation
- FDA Fast Track Designation: Oncolytics Biotech's cancer treatment pelareorep has received Fast Track Designation from the FDA for KRAS-mutant microsatellite-stable metastatic colorectal cancer, which is expected to expedite the approval process and enhance market competitiveness.
- Clinical Data Advantage: The 33% response rate of pelareorep combined with standard chemotherapy significantly surpasses the 10% rate of chemotherapy alone, with a median survival of 27 months, indicating its potential value in hard-to-treat cancer populations.
- Significant Market Opportunity: The annual revenue for second-line treatment of KRAS-mutant colorectal cancer ranges between $3 billion and $5 billion, positioning Oncolytics' innovative therapy to capture a substantial share in this rapidly growing market.
- Team Expansion and Strategic Positioning: Oncolytics Biotech has recently appointed two executives to support its expansion plans, demonstrating the company's commitment to future clinical trials and market outreach, thereby strengthening its leadership position in the biotech sector.
See More
Precision Biologics Market Awakens to $71 Billion Opportunity
- FDA Acceleration: Oncolytics Biotech's cancer treatment pelareorep has received Fast Track Designation from the FDA for KRAS-mutant microsatellite-stable metastatic colorectal cancer patients, demonstrating a 33% response rate significantly higher than the 10% seen with traditional chemotherapy, which will expedite its approval process and enhance market competitiveness.
- Survival Extension: Clinical data shows that patients treated with pelareorep have a median survival of 27 months compared to 11.2 months with standard treatment, indicating the drug's potential market value in hard-to-treat cancer populations, with the global second-line treatment market estimated between $3 billion and $5 billion annually.
- Leadership Team Expansion: Oncolytics Biotech recently appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President of Biostatistics to manage expanding clinical programs, reflecting the company's commitment to future growth and readiness.
- Clinical Trial Plans: The company plans to launch a controlled study in March 2026 comparing standard treatment with pelareorep, with interim data expected by year-end, further validating its efficacy in colorectal cancer treatment.
See More
FDA Accelerates Oncology Drug Approvals, Boosting Market Potential
- Regulatory Acceleration: In 2025, the FDA approved over 50 oncology drugs, with a notable shift towards targeted therapies for high-unmet-need solid tumors in 2026, projecting a market opportunity of $326.82 billion by 2031, indicating robust commercial potential.
- Fast Track Designation: Oncolytics Biotech's pelareorep received FDA Fast Track Designation for KRAS-mutant colorectal cancer, showing a 33% response rate when combined with standard chemotherapy, significantly higher than the 10% with chemotherapy alone, which will expedite its approval process.
- Clinical Trial Plans: Oncolytics plans to launch a controlled study comparing pelareorep with standard care in March 2026, with interim data expected by year-end, providing crucial clinical evidence in a competitive market.
- Team Expansion: Oncolytics Biotech recently appointed two key executives to enhance its strategic and operational capabilities, supporting its expanding R&D projects, reflecting the company's confidence and preparedness for future growth.
See More
Precision Biologics Market Awakens to $71 Billion Opportunity
- FDA Acceleration: Oncolytics Biotech's cancer treatment pelareorep has received Fast Track Designation from the FDA for KRAS-mutant microsatellite-stable metastatic colorectal cancer patients, demonstrating a 33% response rate, significantly higher than the 10% achieved with traditional chemotherapy, which will expedite its market entry and enhance the company's position in the competitive biopharmaceutical sector.
- Significant Survival Extension: Clinical data shows that patients treated with pelareorep have a median survival of 27 months compared to 11.2 months with standard treatment, indicating the drug's potential market value in hard-to-treat cancer populations, with the global second-line treatment market estimated between $3 billion and $5 billion annually.
- Clinical Trial Plans: Oncolytics plans to launch a controlled study in March 2026 comparing standard care versus standard care plus pelareorep, with interim data expected by year-end, laying the groundwork for future product line expansion.
- Leadership Team Expansion: Oncolytics Biotech has recently appointed two key executives to oversee strategy and biostatistics, aiming to strengthen the company's leadership in the rapidly evolving biopharmaceutical landscape to meet the increasing demands of clinical trials.
See More
Oncolytics Biotech Receives FDA Fast Track Designation for Pelareorep
- FDA Fast Track Designation: Oncolytics Biotech announced that its drug pelareorep has received Fast Track designation from the US FDA for second-line metastatic colorectal cancer, specifically targeting KRAS-mutant MSS colorectal cancer, which is expected to expedite its clinical development process.
- Significant Efficacy Data: Clinical data shows that patients receiving pelareorep combination therapy have an objective response rate of 33%, compared to approximately 10% with standard-of-care, indicating a substantial efficacy difference that could change treatment standards.
- Survival Improvement: The median progression-free survival for pelareorep combination treatment is 16.6 months, compared to 5.7 months for standard care, and the median overall survival is 27 months versus 11.2 months for standard care, highlighting its potential in extending patient survival.
- Future Clinical Trial Plans: Oncolytics plans to soon initiate a controlled trial comparing pelareorep combination therapy to standard care alone, further validating its application prospects in KRAS-mutant MSS colorectal cancer patients.
See More
Oncolytics Receives FDA Fast Track Designation for Pelareorep
- Impressive Clinical Data: Oncolytics' pelareorep demonstrates a 33% objective response rate in KRAS-mutant microsatellite-stable metastatic colorectal cancer patients, significantly surpassing the 10% response rate of standard treatment, indicating its potential in difficult-to-treat populations.
- Significant Survival Extension: The therapy achieves a median progression-free survival of 16.6 months compared to 5.7 months with standard care, and a median overall survival of 27 months versus 11.2 months, highlighting its strategic importance in improving patient outcomes.
- Substantial Market Potential: With approximately 2 million new colorectal cancer cases globally each year, the addressable market for second-line KRAS-mutant MSS mCRC is estimated to be between $3 billion and $5 billion, positioning Oncolytics' product for significant market impact.
- Clinical Trial Plans: The company plans to initiate a clinical trial comparing standard treatment with pelareorep by the end of 2026, with up to 10 clinical sites expected to participate, further validating its clinical efficacy and facilitating market entry.
See More
