By Colin Kellaher

 

Shares of Talaris Therapeutics Inc. fell sharply in premarket trading Thursday after the cell-therapy company said it had temporarily halted a Phase 3 study of its lead drug candidate FCR001 in living donor kidney transplant recipients following the death of a patient.

Talaris said it received the report of a patient death on Wednesday, triggering a stopping requirement and review by the study's data-monitoring committee, which determined that trial enrollment and dosing may continue.

Talaris said it has reported the patient's death and the committee's recommendation to the U.S. Food and Drug Administration.

Talaris in June reported that three study subjects had been diagnosed with acute graft-vs-host disease. The company said the deceased patient was one of those subjects, and that while the patient was responding to treatment at the time of the June update, the subject was recently hospitalized with a more severe case of graft-vs-host disease.

Talaris said the data-monitoring committee has concluded that study protocol modifications implemented in June should be sufficient to mitigate the risk of graft-vs-host disease and recommended continuation of the study without further modifications.

Talaris shares, which closed Wednesday at $2.42, were recently down nearly 27% to $1.77 in premarket trading.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

October 20, 2022 08:02 ET (12:02 GMT)

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