Biopharmaceutical company, CG Oncology, Inc. (NASDAQ: CGON) shares experienced a dramatic surge on Monday, with pre-market gains reported as high as 43 per cent and the stock nearly doubling over the past month from approximately $15 to nearly $30.
This significant increase is primarily driven by the release of promising clinical trial data for the company’s lead drug candidate, cretostimogene grenadenorepvec, presented at the American Urological Association (AUA) Annual Meeting in Las Vegas.
The primary catalyst for the stock’s surge is the announcement of “best-in-disease” durability data from the Phase 3 BOND-003 trial, specifically Cohort C. This comes alongside promising early signals from Cohort P. The trial evaluates the prospective drug as a monotherapy for high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
The trial achieved a 75 per cent complete response rate in high-risk bladder cancer patients, marking a significant advancement.
Additionally, this patient group faces limited treatment options, making the result even more important. The data also demonstrated sustained efficacy, positioning cretostimogene as a potential backbone therapy for bladder-sparing treatment.
Furthermore, the U.S. Food and Drug Administration (FDA) granted cretostimogene Fast Track and Breakthrough Therapy designations. These designations, for example, reflect the drug’s potential to meet an unmet medical need and expedite its regulatory pathway.
These results have positioned CG Oncology as a formidable player in the bladder cancer treatment landscape.
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Investor enthusiasm bolstered by positive trial data
The Phase 3 BOND-003 Cohort C study enrolled patients with high-risk non-muscle invasive bladder cancer (NMIBC) who did not respond to Bacillus Calmette-Guerin (BCG) treatment.
These patients had carcinoma in situ (CIS), with or without early-stage Ta or T1 disease.
The study reported a 75.5 per cent complete response rate at any point during treatment. As of the March 14, 2025 cutoff, 34 patients had confirmed complete responses at 24 months. Conversely, 9 patients were still awaiting their 24-month results.
“The compelling efficacy, durability, freedom from progression to muscle-invasive disease, and tolerability of cretostimogene offer potential, distinct advantages over existing therapies for the treatment of high-risk BCG-unresponsive NMIBC,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology.
The data validates CG Oncology’s innovative immunotherapy approach and positions it competitively against larger pharmaceutical companies. For instance, one post described CG Oncology as “rocketing” due to its Johnson & Johnson-rivalling cancer drug.
Furthermore, Scotiabank initiating a Sector Perform recommendation on April 16, 2025, and an average one-year price target of USD$68.17, indicating substantial upside from current levels.
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Institutional investor reflects confidence
Institutional ownership has also played a role in bolstering confidence in CG Oncology. In early April, 325 funds or institutions held positions in the company. This marks a 11.30 per cent increase from the prior quarter. This growing institutional backing reflects confidence in the company’s long-term prospects.
The broader market environment on April 28, 2025, also provided a supportive backdrop. U.S. stocks were generally positive, with the S&P 500, Dow, and Nasdaq rising as investors focused on upcoming Big Tech earnings and economic data.
While CG Oncology’s surge is driven by company specific news, the absence of significant macroeconomic headwinds allowed the stock to capture full investor attention.
In addition to cretostimogene’s promising results, several companies are advancing cancer diagnostics and treatments across the spectrum. Breath Diagnostics, a startup based in Louisville, Kentucky, has developed OneBreath. This is a non-invasive breath analysis system that detects early-stage lung cancer with 94 per cent sensitivity and 85 per cent specificity. This technology offers a cost-effective and accessible screening method, potentially transforming early detection practices.
Another innovative company, Detect-ION, has partnered with Moffitt Cancer Center for a rapid, point-of-care breath diagnostic tool for lung cancer. This collaboration aims to revolutionize early detection by providing quick and non-invasive testing options.
On the pharmaceutical front, Merck KgaA (NYSE: MRK) has announced a USD$3.9 billion acquisition of U.S.-based biotech firm SpringWorks Therapeutics. This strategic move will bump Merck’s oncology portfolio and its adjusted earnings per share by 2027.
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