Talaris Shares Slide Premarket After Patient Death in Phase 3 Study >TALS

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Colin Kellaher. By

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Shares of Talaris Therapeutics Inc fell sharply in premarket trading on Thursday after the cell-therapy company said it has temporarily suspended a phase 3 study of its lead drug candidate FCR001 in living donor kidney transplant recipients following the death of a patient. was stopped from

Talaris said it received reports of a patient’s death on Wednesday, which triggered a need for a halt and review by the study’s data-monitoring committee, which determined that trial enrollment and dosing could continue.

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Talaris said it had reported the patient’s death and the committee’s recommendation to the US Food and Drug Administration.

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

Talaris said the data-monitoring committee concluded that the study protocol amendments implemented in June should be sufficient to reduce the risk of graft-versus-host disease and recommended continuing the study without further modifications.

Shares of Talaris, which closed Wednesday at $2.42, fell nearly 27% to $1.77 in recent premarket trading.

Write to Colin Kellaher at [email protected]

Credit: www.marketwatch.com /

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