CG Oncology, Inc.

75% of C-suite executives in life sciences are optimistic about 2025, citing growth and innovation. AI in biopharma is expanding, with increased investments and partnerships. Cancer vaccines and gene editing are advancing, with late-stage trials and new therapies. VC and IPO markets are rebounding, and M&A activity is expected to increase. Multiomics tools are expanding, and spatial biology is consolidating. Regulatory changes under Trump 2.0 may impact biopharma and health policy.

Biomarker-driven treatment for muscle-invasive bladder cancer showed a 2-year metastasis-free survival rate of over 70% in a phase II study, but missed statistical targets. Active surveillance based on tumor genomics achieved a 2-year MFS of 76%. Despite missing statistical boundaries, the approach shows promise for bladder preservation.

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Sarah Psutka discusses the expanded access program for cretostimogene in BCG-unresponsive bladder cancer, highlighting its 74% complete response rate and strong durability. The EAP aims to gather real-world data from diverse patient populations, addressing access issues and collecting prospective data on safety, efficacy, and patient-reported outcomes.

Protara Therapeutics and CG Oncology presented encouraging Phase II and III data for TARA-002 and cretostimogene grenadenorepvec, respectively, at the Society of Urologic Oncology meeting, showing high complete response rates in non-muscle invasive bladder cancer patients, including those unresponsive to BCG immunotherapy.

CG Oncology announced Phase 3 BOND-003 trial data showing 74.5% of high-risk NMBIC patients achieved complete response after treatment with cretostimogene as a single agent. Median duration of response exceeds 27 months. Data presented at SUO 25th Annual Meeting.

CG Oncology's Phase III data for oncolytic immunotherapy in non-muscle invasive bladder cancer shows high complete response rates, long duration, and good safety/tolerability.

CG Oncology announced Phase 3 BOND-003 trial data for cretostimogene in high-risk BCG-unresponsive NMIBC, showing 74.5% complete response, median duration exceeding 27 months, 63.5% response at 12 months, and 97.3% free from MIBC progression at 12 months. The treatment had a favorable safety profile with no Grade 3+ adverse events.

CG Oncology announces Phase 3 BOND-003 trial data showing 74.5% of high-risk BCG-unresponsive NMIBC patients achieved complete response with cretostimogene monotherapy, with median duration of response exceeding 27 months. No Grade 3 or greater treatment-related adverse events reported. Cretostimogene received FDA Fast Track and Breakthrough Therapy Designations in December 2023.