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On Tuesday, H.C. Wainwright reaffirmed its Buy rating and $75.00 price target for CG Oncology (NASDAQ:CGON) shares, aligning with the broader analyst consensus that remains strongly bullish. With current trading at $28.53, analysts have set targets ranging from $55 to $83, suggesting significant upside potential. The decision follows the presentation of new data from the Phase 3 BOND-003 trial at the 2025 EAU Congress. According to InvestingPro, the company maintains a market capitalization of $2.17 billion and holds more cash than debt on its balance sheet. CG Oncology’s trial evaluated the efficacy of intravesical cretostimogene grenadenorepvec (creto) in treating patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) that includes carcinoma in situ (CIS).
The updated data, with a cut-off date of January 20, 2025, showed an increase in the anytime complete response rate (CRR) to 75.5% (83 out of 110 patients), a slight improvement from the previously reported 74.5%. The 12-month landmark complete response rate remained stable at 46%, and the Kaplan-Meier (K-M) estimate for the same duration continued to hold at 50%. This consistency suggests sustained treatment effectiveness over a longer follow-up period. While the clinical results are promising, InvestingPro data shows the company is not yet profitable, with analysts not expecting profitability this year. However, the company maintains strong liquidity with a current ratio of 35.32.
A notable highlight from the trial was the confirmation of complete response in 30 patients at the 24-month mark. This finding increased the lower bound 24-month CRR to 27.3%, while the estimated K-M 24-month CRR remained steady at 41%. According to the analyst, this demonstrates a significant signal of durability, especially as K-M rates typically decrease over time.
Furthermore, the median duration of response (DoR) for the treatment surpassed 28 months, with the 24-month K-M DoR estimate showing a slight improvement to 58.7%. The analyst emphasized that these results indicate a best-in-class durability profile for creto, outperforming competitors such as pembrolizumab, which has a 16-month median DoR. The enduring immune-oncology effects observed in the trial were considered reminiscent of long-tail immune-oncology effects.
In the analysis, the sustained performance and durability of CG Oncology’s treatment were highlighted as key factors in maintaining the Buy rating and the 12-month price target of $75. CG Oncology’s shares continue to be viewed favorably in light of these promising trial outcomes. Based on InvestingPro analysis, the stock appears overvalued at current levels, despite showing strong return over the last month. For deeper insights into CGON’s valuation and 8 additional ProTips, plus comprehensive financial analysis, investors can access the full Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, CG Oncology, Inc. reported progress in its Phase 3 study of cretostimogene, a treatment for high-risk non-muscle invasive bladder cancer. The study showed a 75.5% complete response rate among participants, with a median duration of response exceeding 28 months. Importantly, no severe treatment-related adverse events were reported, highlighting the treatment’s favorable safety profile. Additionally, CG Oncology announced amendments to executive compensation agreements, providing enhanced severance benefits and equity vesting conditions for key executives in the event of termination or a change in control. Analysts at TD Cowen initiated coverage on CG Oncology with a Buy rating, citing confidence in the company’s product, Creto, and its management team. The analysts projected that Creto could generate $2.5 billion in revenue by 2035, supporting their positive outlook. These developments underscore CG Oncology’s strategic focus on addressing unmet medical needs in bladder cancer treatment. The company’s recent activities reflect ongoing efforts to advance its therapeutic pipeline and strengthen its leadership team.
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