Here’s Why (Nasdaq: ONCY) Is Sitting at the Top of Our Watchlist This Morning With Two FDA Agreements

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Oncolytics Biotech® Inc. (Nasdaq: ONCY) Tops Market Crux's Watchlist This Morning — Monday, July 13, 2026

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Pull Up ONCY While It’s Still Early…

July 13, 2026

Dear Reader,

Before the open this morning, there is one name worth having in front of you — and it is the same name we told you about last night.

The strongest biotech stories are not built on single headlines. They are built through a series of connected developments that accumulate into something the market eventually cannot ignore.

That is what Market Crux believes is taking shape at Oncolytics Biotech® Inc. (Nasdaq: ONCY).

The company has reached agreement with the FDA on two separate registrational pathways while continuing to advance pelareorep through colorectal cancer, anal cancer, and pancreatic cancer programs.

Regulatory progress, clinical data, and a pipeline of upcoming milestones are all contributing to the broader picture that placed ONCY at the top of our watchlist — and with 45 minutes still before the open, you have time to get the full story before the week begins.

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But keep in mind, ONCY appears to be flying under the radar while it’s currently trending below $1.

Meanwhile, several analysts covering ONCY have set targets that stand significantly above its recent range.

In a report published on Friday, Maxim Group analyst Jason McCarthy listed ONCY with a $3 target.

And David Bautz, PhD from Zacks SCR has set a $6 valuation on ONCY

ONCY’s Clinical Results Take Center Stage

Analyst coverage is only one part of what has placed ONCY on our radar.

The more important part is the clinical data supporting pelareorep’s development.

The case here is built on facts: pelareorep just delivered a 33% objective response rate in second-line KRAS-mutant colorectal cancer with a median overall survival of 27 months — compared to approximately 11.2 months for the current standard of care.

That same regimen produced a median progression-free survival of 16.6 months versus 5.7 months for standard treatment.

Those numbers are hard to overlook.

There are three separate programs in motion at ONCY right now — colorectal cancer, anal cancer, and pancreatic cancer — each backed by clinical data, each with a defined regulatory path.

The REO 033 randomized Phase 2 colorectal cancer study launched in March 2026, with preliminary data expected before year-end.

In April 2026, the company reached agreement with the FDA on the design of a registrational anal cancer trial expected to enroll well under 100 subjects.

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And at ASCO 2026, ONCY presented translational data confirming pelareorep’s mechanism across gastrointestinal tumors.

Before we break down what ONCY has built and why it’s on our radar this weekend, here’s a quick look at the company’s foundation.

Inside ONCY’s Clinical Strategy

San Diego-based Oncolytics Biotech® Inc. (Nasdaq: ONCY) is a clinical-stage immunotherapy company developing pelareorep — commonly referred to as “pela” — as an intravenously administered immunotherapy agent for gastrointestinal and other solid tumors.

Pela is derived from the naturally occurring Reovirus and is designed to work by evading immune neutralization in the bloodstream, delivering directly to tumor tissue, and triggering both innate and adaptive immune responses that convert cold tumors into immune-active environments.

The company’s pipeline is focused on GI oncology indications — colorectal cancer, anal cancer, and pancreatic cancer — with clinical data now supporting registration-enabling programs in two of those three settings.

ONCY is led by CEO Jared Kelly, a transactional executive with over 50 deals in his history, including the $2B Ambrx sale to Johnson & Johnson.

CMO Thomas Heineman, M.D., Ph.D. brings nearly 30 years in dr-ug development with expertise spanning virology and oncology. CBO Andrew Aromando contributes over 30 years in oncology portfolio optimization.

ONCY’s Clinical Strategy Across a $150B Market

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Pelareorep competes within the global cancer immunotherapy market, valued at over $136B in 2025 and projected to surpass $150B in 2026 — a sector expanding at a CAGR of 10.42% through 2035 as RAS-mutant cancers — among the hardest to treat — become a central focus for next-generation targeted and immune-based approaches.

Colorectal cancer alone accounts for over 150,000 new diagnoses annually in the United States, with RAS mutations present in approximately 45–50% of cases.

The microsatellite-stable (MSS) subtype — which is immunotherapy-resistant under current checkpoint inhibitor approaches — represents the bulk of that patient population.

Pela’s ability to generate immune responses in MSS-RAS-mutant colorectal cancer, a setting where checkpoint inhibitors have largely failed, positions it differently from most agents currently in development.

Anal cancer represents a smaller but highly underserved indication with no broadly approved second-line standard of care, making the accelerated approval pathway Oncolytics is pursuing particularly relevant.

In pancreatic cancer, where five-year survival rates remain below 13%, any agent that can demonstrate meaningful response rates in combination with chemotherapy and checkpoint inhibition draws immediate attention from both clinical and commercial audiences.

ONCY’s Recent Milestone Timeline

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June 16, 2026

Oncolytics Secures New U.S. Patent Protecting Commercial Manufacturing of Pelareorep into 2044

The USPTO issued a new patent broadly protecting the proprietary manufacturing process for pelareorep into 2044. A previously filed method-of-use patent application — if issued — would extend protection into 2046. Oncolytics also announced plans to file additional patents in 2026 across therapeutic applications, treatment settings, and combination approaches, further building out the pelareorep intellectual property estate ahead of potential commercialization. See full story here.

June 2, 2026

Oncolytics Appoints Steve Glover to Board of Directors and Promotes John McAdory to Chief Operating Officer

Glover brings extensive public company and transaction experience, including serving as Chairman of Ambrx Biopharma during its $2B acquisition by Johnson & Johnson. McAdory, who joined Oncolytics earlier in 2026 from CG Oncology, will oversee clinical operations, preclinical R&D, and strategic partnerships in his expanded role. See full story here.

June 1, 2026

Oncolytics Announces Positive Initial Preclinical Findings Supporting Further Evaluation of Pelareorep in Combination with RAS-Targeted Approaches

Preclinical data showed pelareorep in combination with RAS inhibitors delivered greater anti-tumor activity than either agent alone — opening a potential next-generation combination strategy in KRAS-driven cancers. See full story here.

May 22, 2026

Oncolytics Presents at ASCO 2026, Reinforcing Pelareorep's Potential Across Gastrointestinal Tumors

Translational analyses confirmed that pelareorep expands pre-existing tumor-reactive immune cells and triggers measurable increases in KRAS-specific T-cell clones in pancreatic cancer patients. See full story here.

April 27, 2026

Oncolytics Aligns with FDA on Planned Pivotal Cancer Study

A Type C FDA meeting resulted in alignment on the design of a pivotal single-arm study to support approval of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal — a program built on a 30% objective response rate in second-line or later SCAC, more than double the 13.8% ORR of the current approved second-line treatment. See full story here.

March 19, 2026

Oncolytics Presents New Mechanistic and Translational Data at AACR 2026

Data from the GOBLET pancreatic cancer study showed a 62% objective response rate in first-line metastatic pancreatic ductal adenocarcinoma. See full story here.

March 2, 2026

Oncolytics Launches Randomized Colorectal

Cancer Study — REO 033

The company initiated REO 033, a randomized Phase 2 study comparing pelareorep plus bevacizumab and FOLFIRI against bevacizumab and FOLFIRI alone in second-line RAS-mutant MSS metastatic colorectal cancer. Preliminary data is expected before year-end 2026. The launch followed the FDA's Fast Track Designation for pelareorep in that same indication. See full story here.

7 Developments Putting ONCY at the Top of This Morning’s Watchlist—Monday, July 13, 2026…

1. $150B Market: ONCY is developing pelareorep within the global cancer immunotherapy market, valued at USD 136.39B in 2025 and projected to surpass $150B in 2026.

2. Analyst Coverage: ONCY continues receiving coverage from analysts, including a recent $3 target from Maxim Group and a $6 valuation from Zacks SCR.

3. Upcoming Potential Catalyst: ONCY launched the randomized REO 033 Phase 2 colorectal cancer study in March 2026, with preliminary data expected before year-end.

4. FDA Progress: ONCY has reached agreement with the FDA on registrational pathways in both colorectal cancer and anal cancer, marking two significant regulatory milestones across its clinical pipeline.

5. Strong Survival: ONCY reported a median overall survival of 27 months in second-line KRAS-mutant colorectal cancer, compared to approximately 11.2 months for the current standard of care.

6. Three Programs: ONCY is advancing clinical programs in colorectal cancer, anal cancer, and pancreatic cancer, with each supported by clinical data and ongoing development.

7. Strengthened IP Position: ONCY recently secured a new U.S. patent protecting its proprietary pelareorep manufacturing process into 2044, with additional patent filings planned.

Pull Up ONCY While It’s Still Early…

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The strongest stories are often built through steady execution, and ONCY continues adding meaningful developments across multiple fronts.

Regulatory progress, clinical results, a randomized Phase 2 study already underway, expanding intellectual property, analyst coverage, and a growing gastrointestinal oncology pipeline have all contributed to why Market Crux has moved this company to the top of its watchlist.

As additional clinical and corporate milestones emerge, Market Crux will be watching closely to see how the broader story continues developing.

We're keeping a close eye on ONCY this morning.

Get ONCY on your radar while it’s still early.

Sincerely,

Gary Silver
Managing Editor,
Market Crux

MarketCrux.com (“MarketCrux” or “MC” ) is owned by Headline Media LLC, MC is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile MC brings to your attention. Any emojis used do not have a specific defined meaning, and may be used inconsistently. We do not provide personalized in-vest-ment advice, are not in-vest-ment advisors, and any profiles we mention are not suitable for all in-vest-ors.

Pursuant to an agreement between Headline Media LLC and TD Media LLC, Headline Media LLC has been hired for a period beginning on 07/12/2026 and ending on 07/13/2026 to publicly disseminate information about (ONCY:US) via digital communications. Under this agreement, TD Media LLC has paid Headline Media LLC seven thousand five hundred USD (“Funds”). To date, including under the previously described agreement, Headline Media LLC has been paid twenty two thousand five hundred USD (“Funds”). These Funds were part of the one hundred thousand USD funds that TD Media LLC received from Oncolytics Biotech Inc., the issuer of (ONCY:US).

Neither Headline Media LLC, TD Media LLC and their member own shares of (ONCY:US).

Please see important disclosure information here: https://marketcrux.com/disclosure/oncy-rZCKi/#details

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