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Investigation Commenced by Levi & Korsinsky into CARGO Therapeutics, Inc. (CRGX) Following Discontinuation of FIRCE-1 Clinical Study

New York, NY – Levi & Korsinsky, a leading securities law firm, notifies investors that it has initiated an investigation into CARGO Therapeutics, Inc. (CARGO Therapeutics, Inc.) following the biotech company’s announcement on January 29, 2025, that it would discontinue the FIRCE-1 clinical study for its lead product, firi-cel, in 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 FIRCE-1 Clinical Study

CARGO Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel, targeted therapies for cancer. The FIRCE-1 study was a Phase 2, open-label, single-arm clinical trial designed to evaluate the safety and efficacy of firi-cel in patients with relapsed or refractory LBCL who had previously undergone two or more lines of systemic therapy. The primary endpoint of the study was the overall response rate (ORR) at 28 days.

Reason for Study Discontinuation

The announcement of the study discontinuation came as a surprise to investors, as the company had previously reported positive data from an interim analysis of the FIRCE-1 study in December 2024. In that analysis, firi-cel demonstrated an ORR of 35% (95% CI: 26%-45%) in evaluable patients. However, the company did not provide any specific reasons for the study discontinuation in the press release.

Impact on CARGO Therapeutics and the Biotech Industry

The sudden discontinuation of the FIRCE-1 study has raised concerns among investors about the future of CARGO Therapeutics and the broader biotech industry. Some analysts have suggested that the decision may be related to safety concerns or lack of efficacy data, while others believe it could be due to financial reasons or a strategic shift in the company’s focus. Regardless of the reason, the study discontinuation is likely to negatively impact CARGO Therapeutics’ stock price and investor confidence.

Potential Effects on Individual Investors

Individual investors who have purchased CARGO Therapeutics stock may be considering their options in light of the study discontinuation. Depending on their investment strategy and risk tolerance, they may choose to sell their shares, hold on to them, or even buy more at a potentially lower price. It is important for investors to carefully consider their investment decisions and consult with a financial advisor before making any moves.

Effect on the Biotech Industry as a Whole

The discontinuation of the FIRCE-1 study could have wider implications for the biotech industry as a whole. This event serves as a reminder that clinical trials can be unpredictable and that even promising results can be reversed. It also highlights the importance of transparency and clear communication from companies regarding their clinical trial data and the reasons for any study discontinuations.

Conclusion

In conclusion, the sudden discontinuation of the FIRCE-1 clinical study for firi-cel by CARGO Therapeutics has raised concerns among investors and the broader biotech industry. The reasons for the discontinuation are not yet clear, but the event is likely to negatively impact CARGO Therapeutics’ stock price and investor confidence. It is important for individual investors to carefully consider their investment decisions and consult with a financial advisor. The discontinuation also underscores the importance of transparency and clear communication from companies regarding their clinical trial data and any study discontinuations.

  • Levi & Korsinsky initiates investigation into CARGO Therapeutics following study discontinuation
  • FIRCE-1 study evaluated safety and efficacy of firi-cel in relapsed or refractory LBCL patients
  • Study discontinuation raises concerns about future of CARGO Therapeutics and biotech industry
  • Impact on individual investors: sell, hold, or buy more shares
  • Importance of transparency and clear communication from companies regarding clinical trials

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