Investigation Launched Against CARGO Therapeutics, Inc. over Discontinuation of Clinical Trial
New York, NY – February 12, 2025
Levi & Korsinsky, a leading securities law firm, has announced the commencement of an investigation into CARGO Therapeutics, Inc. (CRGX) following the biotech company’s decision to discontinue its Phase 2 clinical study of firi-cel for patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. The investigation focuses on potential violations of federal securities laws.
Background on CARGO Therapeutics and the FIRCE-1 Study
CARGO Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing novel therapeutics for cancer and inflammatory diseases. The company’s lead product candidate, firi-cel, is an off-the-shelf, allogeneic CAR T-cell therapy designed to target CD47, a protein found on the surface of many cancer cells and associated with poor prognosis in various types of hematological malignancies. The FIRCE-1 study was designed to evaluate the safety, efficacy, and pharmacokinetics of firi-cel in patients with R/R LBCL who had previously received a CD19-directed CAR T-cell therapy.
Impact on CARGO Therapeutics and the Biotech Industry
The discontinuation of the FIRCE-1 study could have significant implications for CARGO Therapeutics. The decision came unexpectedly, as data from the study was expected to be presented at the American Society of Hematology (ASH) annual meeting in December 2024. The sudden halt raises questions about the safety and efficacy of firi-cel and could impact investor confidence in the company.
Moreover, this event could set a precedent for the biotech industry, as investors increasingly scrutinize clinical trial data and its implications for potential treatments. The failure of a clinical trial, particularly one that has already received significant attention and investment, can have far-reaching consequences for a company’s stock price and future prospects.
Potential Effects on Shareholders
Shareholders of CARGO Therapeutics may experience losses due to the discontinuation of the FIRCE-1 study. The unexpected nature of the decision and the lack of clear information regarding the reasons for its termination could lead to increased volatility in the company’s stock price. Additionally, the failure of the study may impact the development of firi-cel and other potential treatments in the pipeline, further affecting shareholder value.
Conclusion
The sudden discontinuation of the FIRCE-1 study by CARGO Therapeutics has raised concerns among investors and industry experts, leading to an investigation by Levi & Korsinsky. The implications for the company and the biotech industry as a whole could be significant, with potential impacts on investor confidence, stock prices, and future prospects for firi-cel and other treatments in development. Shareholders are encouraged to monitor developments closely and consult with their financial advisors for guidance.
- CARGO Therapeutics discontinues Phase 2 clinical study of firi-cel for R/R LBCL
- Levi & Korsinsky launches investigation into potential securities law violations
- Unexpected decision raises questions about safety and efficacy of firi-cel
- Impact on investor confidence and stock price significant
- Biotech industry under increased scrutiny for clinical trial data
