20.10.2022 14:25:33
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Talaris Reports Patient Death In FREEDOM-1 Trial; DMC Recommends Continuation Of Study
(RTTNews) - Talaris Therapeutics, Inc. (TALS) issued a status update on its phase 3 FREEDOM-1 study in living donor kidney transplant recipients. The company has received a report of a patient death, which triggered a pre-specified, temporary stopping requirement and review by the FREEDOM-1 Data Monitoring Committee. After their review, the DMC determined that trial enrollment and dosing may continue. The DMC concluded that the FREEDOM-1 protocol modifications implemented in June 2022 should be sufficient to mitigate the risk.
The company noted that it has reported this event and the DMC's recommendation to the FDA.
Shares of Talaris are down 21% in pre-market trade on Thursday.
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