Welcome to our dedicated page for CG Oncology news (Ticker: CGON), a resource for investors and traders seeking the latest updates and insights on CG Oncology stock.
CG Oncology, Inc. (NASDAQ: CGON) is a late-stage clinical biopharmaceutical company committed to advancing the treatment landscape for bladder cancer. The company focuses on developing and commercializing innovative bladder-sparing therapies, aiming to improve the quality of life for patients dealing with this serious condition.
Core Business and Product Development
At the heart of CG Oncology's mission is their lead investigational candidate, cretostimogene grenadenorepvec. This oncolytic immunotherapy agent is delivered directly into the bladder (intravesically) to target and destroy cancer cells. Cretostimogene is currently undergoing rigorous clinical evaluation in multiple trials:
- BOND-003: A Phase 3 clinical trial targeting high-risk, Bacillus Calmette-Guerin (BCG) unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC).
- CORE-001: A Phase 2 trial testing the combination of cretostimogene with pembrolizumab in high-risk BCG-unresponsive NMIBC.
- PIVOT-006: A Phase 3 monotherapy trial for intermediate-risk NMIBC patients.
- A separate investigator-sponsored trial combining cretostimogene with nivolumab for muscle-invasive bladder cancer.
Recent Achievements and Current Projects
CG Oncology has achieved significant milestones. The final results from the CORE-001 Phase 2 trial were shared at the ASCO conference, showcasing promising data for the combination therapy with pembrolizumab. The company continues to enroll patients in the PIVOT-006 study, targeting overall recurrence-free survival as a primary endpoint.
Partnerships and Collaborations
CG Oncology collaborates closely with leading institutions and pharmaceutical companies, including a clinical collaboration and supply agreement with Merck for the CORE-001 trial. Such partnerships are crucial for advancing their clinical programs and bringing new therapies to market.
Financial Health
While CG Oncology is still in the clinical trial phase, the company diligently pursues funding and manages resources to support its ambitious research and development agenda. Investors and stakeholders are regularly updated on progress through detailed filings with the SEC.
Commitment to Patients
CG Oncology envisions a future where patients with urologic cancers can live with dignity, benefitting from groundbreaking immunotherapies. The company remains dedicated to its goal of transforming the treatment paradigm for bladder cancer.
For the latest updates on CG Oncology, visit their official website at www.cgoncology.com.
CG Oncology (NASDAQ: CGON), a late-stage clinical biopharmaceutical company, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference. Arthur Kuan, the company's Chairman & CEO, is scheduled for a fireside chat on September 6, 2024, at 10:45 am ET in New York, NY.
CG Oncology focuses on developing a potential backbone bladder-sparing therapeutic for bladder cancer patients. Interested parties can access the live audio webcast of the presentation from the Investor Relations section of the company's website at www.cgoncology.com. A replay of the webcast will be available for approximately 90 days after the live presentation concludes.
CG Oncology (NASDAQ: CGON) reported Q2 2024 financial results and business updates. Key highlights:
1. CORE-001 study: 54% complete response (CR) rate at 24 months in BCG-Unresponsive NMIBC with cretostimogene + pembrolizumab.
2. BOND-003 study: 75.2% CR rate in High-Risk, BCG-Unresponsive NMIBC with cretostimogene monotherapy.
3. Initiated Expanded Access Program for cretostimogene grenadenorepvec.
4. Financial highlights: Cash position of $552.9 million as of June 30, 2024. Q2 R&D expenses: $18.5 million. Q2 G&A expenses: $7.5 million. Net loss: $18.9 million ($0.28 per share).
5. Cash runway expected through 2027.
CG Oncology has launched an Expanded Access Program (EAP) for cretostimogene grenadenorepvec in the U.S. for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The first patient has been dosed, and enrollment is ongoing. This move aims to provide more treatment options for NMIBC patients, reflecting CG Oncology's commitment to addressing this recurrent cancer. Key figures in the bladder cancer community, such as Andrea Maddox-Smith from the Bladder Cancer Advocacy Network, emphasize the hope that EAPs represent for patients who have exhausted all approved treatments.
CG Oncology (NASDAQ: CGON) has published final results from its Phase 2 CORE-001 trial of cretostimogene and pembrolizumab in BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) in Nature Medicine and presented them at ASCO 2024.
The trial met its primary endpoint with a 54% complete response (CR) rate at 24 months in the intention-to-treat (ITT) population. The 12-month CR was 57%, with 95% of these patients maintaining CR for an additional 12 months.
Progression-free survival (PFS) at 24 months was 100%, with no patients advancing to muscle invasive or metastatic disease. Cystectomy-free survival (CFS) at 24 months was 80%, and 100% for patients in CR. Treatment-related adverse events were consistent with those of the individual agents.
The combination received FDA Breakthrough Therapy Designation in May 2023, and cretostimogene monotherapy also received Fast Track and Breakthrough Therapy Designations in December 2023. Topline data from the Phase 3 BOND-003 trial is expected by the end of 2024.
CG Oncology (NASDAQ: CGON) has announced final results from its Phase 2 CORE-001 trial of cretostimogene in combination with pembrolizumab for treating BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC). The trial achieved a 54% complete response (CR) rate at 24 months, meeting its primary endpoint. The data will be presented at the ASCO 2024 Annual Meeting. Results show significant efficacy with 83% CR rate at any time and 77.3% at 12 months. Moreover, 95% of patients in CR at 12 months remained in CR for another 12 months. Progression-free survival at 24 months is 100%, with no progression to muscle-invasive or metastatic disease. The Kaplan-Meier estimates for CR rate at 24 months are 69.6%. Treatment-related adverse events were consistent with individual agents. The combination therapy has received FDA Breakthrough Therapy Designation, and CG Oncology plans to incorporate these findings into a future CORE-008 trial.
CG Oncology reported their financial results for the first quarter of 2024, showcasing a 75.2% Complete Response Rate for their Cretostimogene Monotherapy in patients with High-Risk Non-Muscle Invasive Bladder Cancer. The company also dosed the first patient in a Phase 3 trial and presented final results from a Phase 2 trial of Cretostimogene in combination with Pembrolizumab. In addition, they completed an oversubscribed $437 million IPO and expect their cash runway to last until 2027.
CG Oncology, Inc. announced positive Phase 3 BOND-003 study results for cretostimogene monotherapy in treating high-risk, BCG-unresponsive Non-Muscle Invasive Bladder Cancer. The study showed a 75.2% complete response rate with durable responses over 12 months. No Grade 3 or higher treatment-related adverse events were reported. Cretostimogene has the potential to be a preferred therapy over surgical options in this patient population.
FAQ
What is the current stock price of CG Oncology (CGON)?
What is the market cap of CG Oncology (CGON)?
What is CG Oncology, Inc.?
What is the company's lead product?
What are the main clinical trials conducted by CG Oncology?
What recent achievements has CG Oncology made?
Who are CG Oncology's key partners?
Where can I find the latest news about CG Oncology?
What is the focus of CG Oncology's research?
How is CG Oncology funded?
What is the significance of cretostimogene grenadenorepvec?
How does CG Oncology aim to impact bladder cancer treatment?
