Magenta Therapeutics (MGTA) receives clinical hold letter from FDA related to IND to initiate Phase 1/2 clinical trial of MGTA-117 in patients with AML and MDS

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Go back to Magenta Therapeutics (MGTA) receives clinical hold letter from FDA related to IND to initiate Phase 1/2 clinical trial of MGTA-117 in patients with AML and MDS

Magenta Therapeutics Announces Update on U.S. FDA Investigational New Drug Application for MGTA-117 in Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome

July 21, 2021 8:00 AM EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Magenta Therapeutics, Inc. (Nasdaq: MGTA) today announced that it has received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

The FDA is requiring that Magenta develop an additional bioassay to be used in conjunction with the PK/PD model to inform dose escalation decisions in addition to safety monitoring. This... More