Things Just Changed with New Treatments and FDA Approvals - watching INO and also ... ONCY

 

Breaking News

People are suddenly noticing-something interesting is happening in the biotech sector, and it deserves a closer look.

On October 30, the FDA granted accelerated approval to Inovio Pharmaceuticals (INO) for VOCERYQ, a new DNA-based immunotherapy treating recurrent respiratory papillomatosis (RRP), a rare and serious disease that causes recurring growths in the respiratory tract.

What makes this approval particularly interesting is the relatively small clinical study supporting it.

The study enrolled just 32 patients, with 26 included in the primary efficacy evaluation. Of those 26 patients, seven (27%) achieved a complete response, requiring no additional surgery during the 12 months following treatment.

Think about that.

The FDA granted accelerated approval based on encouraging results from a relatively small study, recognizing the medical needs of patients suffering from a serious disease. A confirmatory study will follow.

Now consider Oncolytics Biotech (ONCY).

ONCY is developing Pelareorep (Pela), an investigational immunotherapy being combined with chemotherapy and bevacizumab, a monoclonal antibody, to treat patients with advanced metastatic colorectal cancer (CRC).

These aren't patients with early-stage cancer. They're patients whose cancer has progressed following initial treatment and who face limited treatment options.

ONCY has already received FDA Fast Track designation for its Pela combination in this patient population.

More importantly, the company has reported FDA feedback supporting a potential accelerated approval pathway based on objective response rates, provided future clinical evidence supports that approach.

Its ongoing randomized REO-033 study is designed to determine whether the encouraging results from the earlier REO-022 trial can be confirmed.

Initial clinical results are anticipated by the end of 2026.

Now here's where things get interesting.

INO just demonstrated that accelerated FDA approval can be achieved with a relatively small clinical study when the evidence supports meaningful treatment benefits for patients with serious unmet medical needs.

ONCY is pursuing a different disease and a different clinical endpoint, but there's an important parallel.

Both are developing innovative immunotherapies for patients with serious diseases who need better treatment options NOW.

INO has already demonstrated a path to FDA approval. ONCY has received FDA feedback supporting a potential accelerated approval pathway, but still needs convincing randomized clinical results.

Hmmmm???? —could ONCY's Pelareorep be approaching a similar opportunity for patients fighting ADVANCED CANCER?

The upcoming REO-033 results should help answer that question.

Now, As Far As Stocks?

Look at INO. The stock closed below $1 on Friday. Following the FDA approval announcement, it surged above $2, with some analysts now setting price targets around $5.

All that excitement in just ONE trading day!

Now look at ONCY, still trading under a buck, with skeptics and shorts banging their tables, impatient for clinical results.

The contrast is striking.

INO's FDA approval changed investor expectations almost overnight. Could positive randomized CRC results eventually produce a similar reassessment of ONCY?

It's a speculative possibility, not a guarantee.

But let's not lose sight of what's really important.

Pelareorep is being developed for patients fighting ADVANCED CANCER, people who NEED some help NOW.

The FDA's accelerated approval pathway exists precisely because certain patients facing serious diseases shouldn't have to wait years for potentially beneficial treatments when credible clinical evidence supports earlier access.

INO has just demonstrated that principle in action.

ONCY still has to deliver the clinical evidence, but the regulatory pathway is already part of the discussion.

In Closing

New immunotherapies and accelerated FDA approval pathways are creating opportunities for patients with serious unmet medical needs, and potentially for investors willing to accept the risks.

INO has just shown how quickly the investment landscape can change following an FDA approval.

Now I'll be watching ONCY's upcoming CRC results with considerable interest.

As this story unfolds, the clinical data and evidence ONCY brings forward will pave the way for what comes next.

Stay Watchful.

- Jones Report

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More later so ....Stay tuned, if you dare!

For now, we close by noting that any view on the market and stocks on any particular day may change in the days to come. That is why we watch and see how our views match up with reality.  Looking ahead a few months may be a way to do things - but thinking too deeply about world events and the recent alliances forming, can make projecting ahead a dicey endeavor. 

All in all - we use the word maybe "some", not "too much" and play it accordingly.  Never get arrogant in our notions because things do change - and individual stocks are subject to many factors outside our control. So, we try to -stay aware.

With all the above caveats and attempted prognostications, I will close this post. Stay tuned for more opining on the market and stocks to watch.

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