TALS - Talaris drops 24% after patient death in late-stage trial for lead asset

• Cell therapy company Talaris Therapeutics ( NASDAQ: TALS ) shed ~24% pre-market Thursday after reporting a death in a kidney transplant patient in its Phase 3 trial for lead candidate FCR001.
• The patient who was initially diagnosed with grade II acute graft-vs-host disease (aGvHD) died after being hospitalized due to grade IV GvHD.
• The U.S.-based trial named FREEDOM-1 is designed to evaluate the allogeneic cell therapy FCR001 in 120 living donor kidney transplant (LDKT) recipients.
• The trial’s Data Monitoring Committee (DMC) reviewed the findings on the death and recommended the enrollment and dosing to continue. However, the company has reported the event and DMC’s recommendation to the FDA.
• “Kidney disease and its related effects are why we are conducting FREEDOM-1, with the goal of improving the lives of patients undergoing kidney transplantation,” Chief Executive Scott Requadt.
• With its last update on FREEDOM-1, TALS announced amendments to the trial protocol.

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