Magenta Therapeutics Stock Drops As FDA Issues Clinical Hold On Blood Cancer Candidate IND

The FDA has instituted a clinical hold on Magenta Therapeutics Inc's MGTA Investigational New Drug Application (IND) of MGTA-117.

• In June, the IND was filed to initiate a Phase 1/2 trial of MGTA-117 in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
• The FDA has asked Magenta to develop an additional bioassay to be used in conjunction with the PK/PD model to inform dose escalation decisions in addition to safety monitoring. 
• The clinical hold does not relate to the toxicology or manufacturing of MGTA-117. 
• Magenta has initiated bioassay development. 
• The Phase 1/2 clinical trial of MGTA-117 is intended to evaluate its safety, pharmacokinetics (PK), and pharmacodynamics (PD) as a single agent in the relapsed/refractory AML and MDS patient population. 
• Magenta ended Q2 2021 with more than $200 million in cash sufficient to execute its existing plans.
• Magenta's MGTA-117 program is the Company's lead targeted conditioning product candidate, an antibody-drug conjugate (ADC) designed to deplete hematopoietic stem cells (HSCs) selectively.
• Price Action: MGTA shares are down 14.60% at $7.60 during the market session on the last check Wednesday.
• Related content: Benzinga's Full FDA Calendar.