On Wednesday, H.C. Wainwright initiated coverage on CG Oncology (NASDAQ:CGON), issuing a Buy rating and setting a price target of $75.00. The firm's analyst cited the potential of CG Oncology's late-stage asset, cretostimogene, to address the significant unmet medical needs in the treatment of non-muscle invasive bladder cancer (NMIBC).
Cretostimogene is seen as a promising candidate that could serve various subtypes and patient groups within NMIBC. The market opportunity for cretostimogene begins with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC, which could open the door to a billion-dollar market. The analyst's optimistic outlook is based on three key points: the limitations of the current standard of care, encouraging interim results from the Phase 3 BOND-003 study, and positive feedback from Key Opinion Leaders (KOLs) on the potential approval and use of cretostimogene.
The standard of care for NMIBC includes transurethral resection of bladder tumor (TURBT) and BCG, which have significant shortcomings. The recent approvals of diverse modalities have not fully addressed these issues. However, the Phase 3 BOND-003 study has shown promising results, with a 74.4% complete response rate at any time and a clean toxicity profile, which could significantly de-risk the approval process for cretostimogene in treating high-risk BCG-unresponsive NMIBC.
KOLs have expressed optimism about the approval and use of cretostimogene in both academic and community settings, which would benefit urologists and oncologists. The analyst's report includes highlights from NMIBC KOL events that provide context for cretostimogene's positioning in NMIBC relative to competitor therapies.
With these factors in mind, H.C. Wainwright has set a bullish stance on CG Oncology, initiating the company with a Buy rating and a price target of $75.00. The firm's analysis suggests that cretostimogene has the potential to make a significant impact on the treatment landscape for NMIBC.
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