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Stock impact report

Carisma Therapeutics' solid tumour therapy obtains FDA Fast Track status [Yahoo! Finance]

Carisma Therapeutics, Inc. (CARM) 
Company Research Source: Yahoo! Finance
An ex vivo gene-modified autologous chimeric antigen receptor-monocyte cellular therapy, CT-0525 is being analysed in a Phase I clinical trial. The open-label trial is designed to assess the safety, tolerability, and manufacturing feasibility of the therapy. Participants enrolled in the trial will include those with locally advanced (unresectable) or metastatic solid tumours that overexpress HER2 and have advanced following treatment with standard therapies approved presently. The trial will also feature two dose escalation cohorts to determine the optimal dose of CT-0525. With the receipt of FDA Fast Track status, CT-0525 is now poised for an accelerated review process. Carisma Therapeutics CMO Eugene Kennedy said: “Receiving Fast Track designation for CT-0525 from the FDA marks a significant milestone for Carisma, highlighting the FDA's recognition of the serious and life-threatening nature of these malignancies and the potential of CT-0525 to meet this critical medical n Show less Read more
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