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On Monday, H.C. Wainwright reaffirmed its Buy rating and $75.00 price target for CG Oncology (NASDAQ:CGON), representing significant upside potential from the current price of $26.42. With analyst targets ranging from $55 to $82 and a strong consensus recommendation of 1.38 (Buy), Wall Street appears optimistic about the company’s prospects. The firm’s analyst, Andres Maldonado, highlighted the upcoming American Urological Association (AUA) 2025 meeting as a pivotal moment for the company. According to InvestingPro analysis, CGON currently shows a FAIR overall financial health score of 2.11 out of 5. CG Oncology is set to present final 12-month data from its BOND-003 trial at the event, which could be a significant milestone in the treatment of high-risk BCG-unresponsive NMIBC.
The BOND-003 trial results will be directly compared with those of J&J’s TAR-200. While both treatments have demonstrated promising outcomes, the AUA meeting is expected to provide clarity on their efficacy, durability, and safety—key factors in establishing a new standard of care. CG Oncology’s cretostimogene has shown a 46% complete response rate at 12 months in a trial with 110 patients, and a 41% estimated durability rate at 24 months, with no Grade 3 or higher treatment-related adverse events or discontinuations due to toxicity.
In contrast, TAR-200’s estimated 12-month complete response rate stands at 57% based on Kaplan-Meier projections, but lacks corresponding actual landmark data. Interim analyses suggest that the real 12-month complete response rate for TAR-200 might be significantly lower, which raises concerns about the potential overestimation from Kaplan-Meier modeling.
Maldonado also pointed out that the comparison between the two treatments extends beyond efficacy numbers. Investors are expected to consider the tolerability profiles and administration logistics of each. Cretostimogene is administered intravesically, a method familiar to urology clinics, which may be an advantage over TAR-200’s device-based delivery that requires cystoscopy-based insertion, potentially limiting its ease of use. Additionally, TAR-200 has been associated with a higher incidence of Grade 3 or higher adverse events, with 9% of patients experiencing severe events and 6% discontinuing treatment due to adverse effects, compared to none for cretostimogene.
In light of the upcoming data release and the comparative analysis between cretostimogene and TAR-200, H.C. Wainwright has reiterated its Buy rating and $75 price target for CG Oncology stock. The company maintains a strong financial position with a current ratio of 35.3, and notably holds more cash than debt on its balance sheet, providing financial flexibility to support its clinical development programs. With the next earnings report expected on May 8, 2025, investors can access detailed financial analysis and valuation metrics through InvestingPro’s comprehensive research tools.
In other recent news, CG Oncology has reported significant advancements in its Phase 3 study of cretostimogene for treating high-risk non-muscle invasive bladder cancer. The study, involving 110 patients, demonstrated a 75.5% complete response rate at some point during the trial, with a median duration of response exceeding 28 months. H.C. Wainwright maintained its Buy rating for CG Oncology, citing the promising trial outcomes and setting a price target of $75. Additionally, TD Cowen initiated coverage of CG Oncology with a Buy rating, highlighting the potential of cretostimogene and projecting significant revenue by 2035.
Furthermore, CG Oncology announced amendments to executive compensation agreements, enhancing severance benefits and equity vesting conditions for key executives, including the CEO and President/COO. These revised agreements include substantial benefits in the event of termination without cause or during a change in control period. The company’s recent developments underscore its strategic focus on advancing treatments for bladder cancer and ensuring executive stability during its growth phase. These updates reflect CG Oncology’s ongoing efforts to solidify its position in the biotechnology sector.
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