| Moving Green Early, (Nasdaq: ONCY) Grabs The Headlines Wednesday (FDA Fast Track Designation)
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February 4th Greetings, Friend!
Oncolytics Biotech Inc. (Nasdaq: ONCY) is hitting the spotlight early Wednesday and is surging green.
Could it be because of this massive breaking news?
Check it out:
Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer
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SAN DIEGO, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation to pelareorep in combination with bevacizumab (Avastin®) and leucovorin, fluorouracil, irinotecan (“FOLFIRI”) for the treatment of patients with KRAS (“Kirsten rat sarcoma”)-mutant, microsatellite-stable (“MSS”) metastatic colorectal cancer (“mCRC”) in the second-line (“2L”) 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.
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“This designation is an important validation of our focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate in a market that is estimated to be worth several Bn dollars. Pelareorep offers the potential to help a meaningful number of patients, and I look forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible.”
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Read the full article here.
When it comes to attention-grabbing news, this one is up there!
Don't forget. MarketBeat is reporting an average analyst target for ONCY suggesting potential triple-digit upside from this profile's opening valuation Wednesday.
Review my initial (Nasdaq: ONCY) report below and consider this idea for your radar. -----
What a ride — did you see our latest Nasdaq spotlight?
It was special.
From Monday’s 4:00PM EST close at $0.609, the profile soared to a high of $0.944 by Tuesday — a quick, approx. 55% jump that made for one impressive start to the week.
Now, we’re focusing on something that could be even more compelling.
At the forefront of cancer research, a pioneering organization is changing how the immune system is used to fight disease.
Its platform merges viral therapy with immunology to take on the toughest cancers, pushing the boundaries of traditional treatment.
With steady clinical momentum and growing respect across the oncology field, this company’s work could reshape the future standard of care.
And with an average analyst target pointing to the potential for triple-digit upside, this Nasdaq profile is now on our radar: Oncolytics Biotech Inc. (Nasdaq: ONCY).
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent.
Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer.
The Boundless Promise Of Pelareorep
Pelareorep is a first-in-class, nonpathogenic, oncolytic virus that can be delivered intravenously and works by generating, recruiting, and training immune cells to recognize and kill cancer while remodeling the tumor microenvironment to enable immune cell access.
In addition to its demonstrated single-agent activity, pelareorep can also work in synergy with chemotherapy, immune checkpoint inhibitors (ICIs), CAR T-cell therapy, proteasome inhibitors, bispecific antibodies, and CDK4/6 and PARP inhibitors to enhance its antitumor potential and meaningfully extend patient remissions.
Pelareorep specifically targets cancer cells and induces a cascade of inflammatory responses that activate the innate and adaptive immune system to destroy the tumor while sparing normal tissue.
Pelareorep’s unique ability to introduce double-stranded RNA, a powerful immune stimulant, directly into cancer cells results in PD-L1 upregulation and cytokine and chemokine production, inducing enhanced infiltration and T-cell activation. Because pelareorep replicates only in tumor cells, it is well-tolerated by patients.
Pelareorep Proposed Mechanism Of Action | 
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