Investigation Launched Against CARGO Therapeutics, Inc. (CRGX) for Potential Securities Law Violations
New York, NY – Levi & Korsinsky, a leading securities law firm, has initiated an investigation into CARGO Therapeutics, Inc. (CARGO Therapeutics, Inc.) (NASDAQ: CRGX) following the biotech company’s announcement on January 29, 2025, that it would be discontinuing its Phase 2 clinical study of firi-cel for patients with large B-cell lymphoma (LBCL) whose disease had relapsed or was refractory (R/R) to CD19 CAR T-cell therapy.
Background on CARGO Therapeutics and Firi-cel
CARGO Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing novel therapeutics for patients with cancer. Firi-cel is a CD47-blocking antibody-drug conjugate (ADC) that the company is developing in collaboration with AstraZeneca. The drug is designed to target CD47, a protein that plays a critical role in cancer progression and immune evasion.
Details of the Discontinued Clinical Trial
The Phase 2 clinical study, known as FIRE-1, was designed to evaluate the safety and efficacy of firi-cel in combination with AstraZeneca’s Imfinzi (durvalumab) in patients with R/R LBCL who had previously received two or more lines of systemic therapy. The trial was expected to enroll approximately 120 patients at around 40 sites in the United States, Europe, and Asia.
Implications of the Trial Discontinuation
The decision to discontinue the FIRE-1 trial came after a review of the available data by CARGO’s Data Monitoring Committee (DMC). The company stated that the DMC identified a higher than expected rate of adverse events, particularly Grade 3 or 4 neutropenia, in the firi-cel arm of the study. Neutropenia is a condition characterized by a decrease in the number of neutrophils, a type of white blood cell, in the blood.
As a result of the trial discontinuation, CARGO Therapeutics’ shares experienced significant volatility, with the stock price dropping by more than 50% on the day of the announcement.
Impact on Individual Investors
The discontinuation of the FIRE-1 trial raises concerns about the future of CARGO Therapeutics and the potential value of its stock. Investors who have held CRGX shares may experience losses, particularly those who have recently purchased the stock based on optimism surrounding the firi-cel program. It is essential for these investors to closely monitor developments related to the company and consider their investment strategies accordingly.
Global Implications
The implications of this development extend beyond the immediate impact on CARGO Therapeutics and its shareholders. The biotech industry as a whole could be affected, as investors may become more cautious about investing in clinical-stage companies with experimental therapies. Additionally, the setback for CARGO Therapeutics could delay the development of firi-cel and potentially impact the broader field of CD47-targeted therapies.
Conclusion
The decision by CARGO Therapeutics to discontinue its FIRE-1 clinical trial for firi-cel has raised concerns about potential securities law violations and significant implications for the company, its investors, and the biotech industry as a whole. Levi & Korsinsky is investigating these matters and encourages investors who have purchased CARGO Therapeutics stock to contact the firm for more information.
- Levi & Korsinsky initiates investigation into CARGO Therapeutics, Inc. (CRGX)
- FIRE-1 clinical trial for firi-cel discontinued due to higher than expected adverse events
- Impact on individual investors: potential losses and investment strategy considerations
- Global implications: increased caution in investing in clinical-stage companies and potential delays in CD47-targeted therapies