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Oncolytics Biotech Inc. (Nasdaq: ONCY) Is At The Top Of The Street Ideas Watchlist This Morning
—Monday, September 14, 2026…
Don’t Miss Our Next Update—Get Real-Time Alerts Sent Directly To Your Phone. Up To 10X Faster Than Email. Take A Close Look At (ONCY) While It’s Still Early… September 14, 2026 Dear Reader, The countdown to the bell is underway, and Oncolytics Biotech Inc. (Nasdaq: ONCY) is sitting near the top of our screen. Its clinical progress and growing regulatory momentum make this a story worth following closely this morning. Here's what you need to know about gastrointestinal cancers right now. They're the fastest-growing cancer category among adults under 50 worldwide. Colorectal cancer alone accounts for roughly 1.9M new diagnoses every year. Metastatic pancreatic cancer carries a five-year survival rate of just 3%. And in advanced anal cancer, patients who progress after front-line therapy currently have zero FDA-approved options to turn to… None. That tells you something about the size of the unmet need here. It also tells you something about what happens when a compound starts producing real results across all three of those spaces simultaneously. So when a clinical-stage immunotherapy starts producing 2-3x improvements over standard-of-care benchmarks across all three of those indications — and then gets the FDA to agree on a registrational path forward — that's worth your attention. Oncolytics Biotech Inc. (Nasdaq: ONCY) is developing pelareorep, a first-in-class double-stranded RNA immunotherapy that works through a dual mechanism. It selectively replicates inside tumor cells. And at the same time, it activates both innate and adaptive immune responses — turning immunologically "cold" tumors "hot." That's a different kind of approach. Most immunotherapies work through a single mechanism. Pelareorep works through two — direct oncolytic activity inside the tumor cell and systemic immune activation outside of it… And the results are starting to speak for themselves. These are only some of the reasons why we're announcing coverage on (Nasdaq: ONCY) this morning, Monday, September 14, 2026. 
And as of right now, three analysts currently cover (ONCY)… Jason McCarthy of Maxim Group carries a $3 target, while Patrick Trucchio of H.C. Wainwright and Chad Messer of Lake Street each carry $5 targets — suggesting more than 500% upside from the recent $.75 range. Here's What the Clinical Data Actually Shows
Let's go indication by indication. In second-line KRAS-mutant metastatic colorectal cancer, the REO 022 study delivered progression-free survival of 16.6 months compared to 5.7 months for standard-of-care benchmarks. Overall survival hit 27 months versus 11.2 months. Objective response rate came in at 33% versus 6-11%… And the median duration of response reached 19.5 months — compared to just 4-6 months for recently approved targeted therapies. That's a 2-3x improvement across nearly every key endpoint. You don't see that kind of separation from benchmarks very often. These are RAS-mutant tumors — the kind that resist most existing therapies and make second-line treatment notoriously difficult. The durability of response is the part that really jumps off the page. A 19.5-month median duration means patients aren't just responding — they're staying on therapy and maintaining that response far longer than what's currently expected in this setting. Now look at advanced squamous cell anal carcinoma (SCAC)… The GOBLET study showed a 30% objective response rate in patients whose disease had already progressed. That's more than double the historical benchmarks. Duration of response reached approximately 15.5 months versus 9.5 months for the current approved therapy. And the 12-month overall survival rate was 82% compared to 45.7%. That 82% number is worth pausing on. In a cancer with limited options and poor second-line outcomes, getting eight out of ten patients past the 12-month mark changes the conversation. Keep in mind — there are no FDA-approved therapies for these patients after front-line treatment. Then there's pancreatic cancer… In first-line metastatic pancreatic ductal adenocarcinoma, pelareorep-based therapy showed a 2-year survival rate of approximately 22% versus roughly 9.2% across comparator arms from landmark studies. That's a ~2.5x improvement in what's widely considered oncology's toughest challenge — an indication where no immunotherapy has been approved and where the standard of care has remained largely unchanged for years. The compound's been administered to more than 1,200 patients across multiple cancer types, with a pooled safety analysis of over 500 patients showing no maximum tolerated dose and a "generally well-tolerated" profile. That safety profile matters. It's the kind of thing that doesn't show up in a headline, but it shapes the entire development story. It means pelareorep can be layered onto existing regimens without adding a significant burden — a critical feature for any compound designed to work across multiple tumor types and combination settings. The FDA Just Agreed to a Path Forward
You don't always see this from a clinical-stage company… Three Fast Track designations from a single agency in a span of less than four years — and all in the same therapeutic area. Oncolytics Biotech Inc. (Nasdaq: ONCY) now holds three separate Fast Track designations from the FDA — colorectal cancer (February 2026), anal cancer (July 2026), and pancreatic cancer (late 2022). Each one validates the agency's recognition that pelareorep addresses serious diseases with significant unmet medical needs. It also opens the door to more frequent regulatory interactions, rolling review of a future application, and potential Priority Review eligibility — tools that compress timelines and keep momentum moving forward. But here's the part that really stands out… On August 18th, the FDA provided written alignment on a potential pivotal Part B expansion of REO 033 — the company's ongoing controlled study in second-line RAS-mutant MSS metastatic colorectal cancer. That feedback included alignment around using objective response rate to support an accelerated approval pathway… With progression-free survival supporting full approval. "We are thrilled with the response provided by the FDA and believe this feedback could support a highly efficient path to potentially transition REO 033 from its ongoing randomized Part A directly into a pivotal Part B," said Jared Kelly, CEO of Oncolytics Biotech Inc. (Nasdaq: ONCY). REO 033 is currently enrolling patients at 15-20 U.S. sites, with preliminary data expected Q4 2026. Final GOBLET cohort 4 data from the anal cancer program is expected in the second half of 2026, and the company's seeking a partnership to advance toward a pivotal controlled study there. What's Building Behind the Headline Programs
There's more going on under the surface here… On September 10th, Oncolytics Biotech Inc. (Nasdaq: ONCY) announced positive preclinical results combining pelareorep with a pan-RAS inhibitor in a RAS-driven colorectal cancer model. Pelareorep activity was maintained in the presence of RAS inhibition — no antagonism between the two therapies. That's significant. Acquired resistance is the main limitation of RAS-targeted therapies right now, and it's the reason patients on these therapies eventually see their responses fade. If pelareorep can deepen and extend responses to that entire emerging class, it opens a substantial new combination pathway — one that could matter across multiple tumor types where RAS mutations drive progression. "These results provide an encouraging first look at combining pelareorep with one of the most important emerging classes of targeted cancer therapies," said Thomas Heineman, MD, PhD, Chief Medical Officer. The preclinical pipeline doesn't stop at RAS inhibitors, either — the company's also advancing combination programs with CAR-T therapies, bispecific antibodies, and antibody-conjugate platforms. On the IP side, 139 patents have been issued worldwide, with a new manufacturing patent extending protection to 2044 and method-of-use filings expected to cover through 2046. Manufacturing is another quiet strength — pelareorep's a non-genetically modified reovirus made in Carlsbad, California, with high yield, low cost-of-goods, and no special handling requirements. That kind of production profile could translate well to commercial-scale output across multiple indications — something that becomes increasingly relevant as the pipeline advances toward potential registration. Now look at the addressable market — because the numbers tell you about scale… Colorectal cancer therapeutics represent approximately $20B growing at 4.7% CAGR to 2033, with immunotherapy as the largest and fastest-growing segment. The U.S. anal cancer market's an estimated $1B annual commercial opening — with no approved second-line therapies. 
And pancreatic cancer treatment's projected to reach $3B with a 15% CAGR to 2032, per Fortune Business Insights. CEO Jared Kelly brings more than 50 completed transactions to the table, including a $2B acquisition, and CMO Thomas Heineman has nearly 30 years of virology and oncology development experience. That's a management team that's done this before. Combined, pelareorep's three lead GI programs target a combined addressable market well above $25B — with the company currently valued at just $101M per Yahoo Finance. 9 Factors That Just Put (ONCY) At The Top Of The Radar This Morning—Monday, September 14, 2026
1. Analyst Coverage: three analysts covering ONCY carry targets ranging from $3 to $5, pointing to significant upside potential from the recent $0.75 range. 2. Colorectal Data: in second-line KRAS-mutant metastatic colorectal cancer, ONCY reported 16.6-month progression-free survival versus a 5.7-month benchmark and 27-month overall survival versus 11.2 months. 3. Anal Cancer: the GOBLET study from ONCY showed a 30% objective response rate and an 82% 12-month overall survival rate versus a 45.7% historical benchmark. 4. Pancreatic Signal: in first-line metastatic pancreatic cancer, ONCY reported an approximately 22% two-year survival rate versus roughly 9.2% across comparator arms from landmark studies. 5. Three Fast Tracks: pelareorep from ONCY holds three separate FDA Fast Track designations covering colorectal, anal, and pancreatic cancer programs. 6. FDA Alignment: in August, ONCY received written FDA alignment on a potential pivotal Part B expansion of REO 033, including use of objective response rate to support a potential accelerated approval pathway. 7. Near-Term Data: REO 033 from ONCY is enrolling at 15-20 U.S. sites with preliminary colorectal cancer data expected in Q4 2026. 8. Patent Position: the intellectual property portfolio behind ONCY includes 139 issued patents worldwide, with manufacturing protection extending to 2044 and method-of-use filings expected through 2046. 9. Market Scale: pelareorep’s three lead GI programs give ONCY exposure to addressable markets totaling more than $25B while the company was listed at a $101M valuation. Take A Close Look At (ONCY) While It’s Still Early…
If you're watching oncology for clinical-stage names backed by deep data and a clear registrational framework, Oncolytics Biotech Inc. (Nasdaq: ONCY) deserves a closer look. Check out (ONCY) while it’s still early. Keep an eye on your inbox and mobile device. Our next update could be hitting very shortly. Sincerely, Paul Prescott
Co-Founder & Managing Editor
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