Talaris Therapeutics, a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today announced a status update on its Phase 3 FREEDOM-1 study in living donor kidney transplant (LDKT) recipients.
On October 18, 2022, the Company received a report of a patient death, which triggered a pre-specified, temporary stopping requirement and review by the FREEDOM-1 Data Monitoring Committee (DMC). After their review of this case, the DMC determined that trial enrollment and dosing may continue.
… The deceased patient was one of three study subjects reported in June 2022 to have been diagnosed with grade II acute graft-vs-host disease (aGvHD). As reported, this patient was also diagnosed with moderate chronic GvHD that was responding to treatment at the time of the update. The patient was recently hospitalized with grade IV GvHD that was complicated by serious infections leading to respiratory and renal failure, and ultimately death.
With today’s selloff compounding the (related) selloff from Jun 2022 (#msg-169290034), the share price is now down 92% from its mid-2021 IPO (#msg-163667557).
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”