Investigation Launched Against CARGO Therapeutics, Inc. (CRGX) for Potential Securities Law Violations
New York, NY – Levi & Korsinsky, a leading securities law firm, announced today that it has commenced an investigation of CARGO Therapeutics, Inc. (CARGO Therapeutics, Inc.) (NASDAQ: CRGX) for potential securities laws violations. The investigation concerns the Company’s disclosure regarding 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.
Background on CARGO Therapeutics and Firi-cel
CARGO Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of first-in-class, targeted therapies for cancer. Firi-cel is a CD47 blocker that targets the immunosuppressive signal of CD47 on cancer cells, allowing the immune system to recognize and destroy the cancer cells. The Phase 2 clinical trial of firi-cel for R/R LBCL was designed to evaluate the safety, efficacy, and pharmacokinetics of the drug in combination with standard of care (SoC) chemotherapy.
Discontinuation of the FIRCE-1 Study and Its Implications
On January 29, 2025, CARGO Therapeutics announced the discontinuation of the FIRCE-1 study due to a lack of efficacy. Specifically, the Company stated that “the data from the FIRCE-1 study showed that while firi-cel was generally well-tolerated, the combination of firi-cel and SoC did not demonstrate a statistically significant improvement in progression-free survival (PFS) or overall survival (OS) compared to SoC alone. As a result, CARGO Therapeutics has decided to discontinue the FIRCE-1 study and will not pursue further development of firi-cel in combination with SoC for the treatment of R/R LBCL.”
Impact on CARGO Therapeutics and the Biotech Industry
The discontinuation of the FIRCE-1 study and CARGO Therapeutics’ decision to halt the development of firi-cel in combination with SoC for R/R LBCL could have significant implications for the Company and the biotech industry as a whole. Some potential consequences include:
- Financial Impact: The termination of the FIRCE-1 study and the abandonment of the combination therapy may result in financial losses for CARGO Therapeutics. The Company had previously reported that it expected to incur approximately $10 million to $12 million in research and development expenses related to the FIRCE-1 study in 2025. Additionally, the failure of firi-cel to demonstrate efficacy in the combination therapy may impact the Company’s ability to secure future partnerships or funding.
- Investor Confidence: The discontinuation of the FIRCE-1 study and the failure of firi-cel to meet its primary endpoints may negatively impact investor confidence in CARGO Therapeutics. This, in turn, could lead to a decline in the Company’s stock price and decreased liquidity.
- Industry Impact: The failure of firi-cel to demonstrate efficacy in combination therapy for R/R LBCL may impact the broader biotech industry, particularly in the field of immuno-oncology. This may lead to increased scrutiny of similar clinical trials and a renewed focus on the importance of rigorous data analysis and clinical trial design.
Conclusion
The investigation launched by Levi & Korsinsky into potential securities laws violations related to CARGO Therapeutics’ disclosures regarding the FIRCE-1 study and the development of firi-cel is a significant development for both the Company and the biotech industry. The discontinuation of the FIRCE-1 study and the failure of firi-cel to demonstrate efficacy in combination therapy for R/R LBCL may have far-reaching consequences, including financial losses, decreased investor confidence, and increased industry scrutiny. As the investigation unfolds, it will be important for investors to stay informed and seek the advice of qualified securities attorneys.
If you are a shareholder of CARGO Therapeutics and have questions about your legal rights, or believe that you have suffered a securities loss in connection with the Company’s disclosures, please contact Levi & Korsinsky, LLP at 212-363-7500. For more information, please visit
About Levi & Korsinsky, LLP:
Levi & Korsinsky is a national firm with offices in New York, Connecticut, California, and Washington D.C. The firm’s attorneys have extensive expertise in prosecuting securities litigation involving financial fraud, accounting fraud, and consumer protection violations. For more information, please visit
