If you haven’t been paying attention to CG Oncology (NASDAQ: CGON), now’s the time.

The biotech company’s stock just popped nearly 40%, and for good reason.

Its experimental bladder cancer drug, cretostimogene grenadenorepvec (yes, it’s a mouthful), just delivered impressive new results from its Phase 3 BOND-003 trial, sending a bullish signal to both Wall Street and the medical community.

75.5% Complete Response Rate

At the 2025 American Urological Association Annual Meeting, CG Oncology revealed new data from Cohort C of its ongoing BOND-003 Phase 3 study.

The drug is designed to treat high-risk non-muscle invasive bladder cancer (NMIBC) in patients who didn’t respond to the common BCG treatment.

This drug showed a 75.5% complete response (CR) rate at any time. Also, 42.3% of patients remained in complete response after 24 months, and 97.3% of patients avoided progression to muscle-invasive bladder cancer.

For a high-risk, previously unresponsive group of patients, these results are nothing short of phenomenal.

Bladder Cancer is Hard to Treat in Its Early Stages

…especially when it doesn’t respond to BCG (Bacillus Calmette-Guérin), the decades-old standard of care. Many patients are left with limited options, often facing invasive surgeries like bladder removal.

That’s what makes CG Oncology’s approach such a potential game changer.

Cretostimogene is a genetically modified virus therapy that targets and destroys bladder cancer cells while stimulating the immune system, all without the severe side effects of chemotherapy or radiation.

And speaking of side effects…

The Latest Results Weren’t Just About Efficacy

Safety matters, too, and CG Oncology nailed it.

According to the report no Grade 3 or higher treatment-related adverse events, no deaths related to treatment, and no median resolution time for side effects. It took just one day.
And 97.3% of patients completed all treatments.

That’s huge in oncology, where toxicity often ends promising trials. Patients were not only benefiting from the drug, but they were tolerating it exceptionally well.

CGON Jumps Nearly 40%

As of the last check on April 28, 2025, CGON stock was trading at $31.30, up 39.9%. The stock surged after investors digested the data and realized this wasn’t just another biotech press release, it was a true signal of potential regulatory approval and commercial success.

With no approved treatment for this exact patient population and a clear unmet need, the FDA will be paying attention.

Bladder Cancer Doesn’t Make Headlines Often

If CG Oncology continues delivering strong data and gets FDA approval, it could carve out a lucrative niche in the bladder cancer space.

The addressable market is large, and no one else has cracked the code for BCG-unresponsive NMIBC with a single-agent viral therapy.

Plus, with a well-tolerated profile and high compliance (97.3% completion rate), this therapy could become the standard of care if approved.

Investors looking for an overlooked biotech with blockbuster potential might want to add CGON to their watchlist or portfolio.