Investigation Launched into CARGO Therapeutics, Inc. Following Discontinuation of Clinical Study
New York, NY – February 23, 2025
Levi & Korsinsky, a leading securities law firm, has announced the commencement of an investigation into CARGO Therapeutics, Inc. (CRGX) regarding potential securities laws violations. The investigation comes in the wake of the biotech company’s announcement on January 29, 2025, that it had decided to discontinue 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
CARGO Therapeutics is a clinical-stage biotechnology company focused on developing allogeneic, off-the-shelf cell therapies for hematologic malignancies and solid tumors. The company’s lead product candidate, firi-cel, is an allogeneic chimeric antigen receptor T-cell (CAR-T) therapy designed to target CD47, a protein that plays a role in inhibiting the body’s immune response to cancer. The Phase 2 study, named FIREFINISH, was designed to evaluate the safety and efficacy of firi-cel as a monotherapy in patients with R/R LBCL who had failed or were intolerant to standard therapies.
Discontinuation of the Clinical Study
In the press release, CARGO Therapeutics announced that the decision to discontinue the FIREFINISH study was based on a recommendation from the independent Data Monitoring Committee (DMC) following a review of the data from an interim analysis. The company stated that the DMC identified a higher than expected rate of serious adverse events (SAEs) in the study. Specifically, six patients (15%) in the firi-cel arm experienced SAEs, compared to two patients (5%) in the control arm. The most common SAEs in the firi-cel arm were Grade 3/4 infections and neurotoxicity.
Implications for Investors
The discontinuation of the FIREFINISH study has raised concerns among investors regarding the safety and efficacy of CARGO Therapeutics’ lead product, firi-cel. The stock price of CRGX dropped significantly following the announcement, falling from a high of $46.65 per share on January 28, 2025, to a low of $24.10 on February 1, 2025. The stock has since recovered somewhat, but remains well below its previous highs.
Implications for the Biotech Industry
The discontinuation of the FIREFINISH study and the resulting impact on CARGO Therapeutics’ stock price highlights the risks associated with investing in the biotech industry, particularly in the field of cell and gene therapies. These therapies are often complex and expensive to develop, and the path to regulatory approval can be lengthy and uncertain. Additionally, the high costs and complexities of these therapies can make them difficult to manufacture and distribute on a large scale, which can limit their potential market size and revenue potential.
Conclusion
The investigation into CARGO Therapeutics by Levi & Korsinsky is a reminder of the importance of transparency and clear communication in the biotech industry. The discontinuation of the FIREFINISH study and the subsequent stock price volatility underscores the risks associated with investing in this sector, particularly in the area of cell and gene therapies. As the industry continues to evolve, it will be important for companies to provide clear and accurate information to investors regarding the safety and efficacy of their products, as well as the potential risks and challenges associated with their development and commercialization.
- CARGO Therapeutics announces discontinuation of Phase 2 clinical study for firi-cel
- Levi & Korsinsky launches investigation into potential securities laws violations
- Decision based on recommendation from independent Data Monitoring Committee
- Higher than expected rate of serious adverse events in firi-cel arm
- Impact on CARGO Therapeutics stock price
- Implications for investors and the biotech industry
