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

·1 min read

The FDA has instituted a clinical hold on Magenta Therapeutics Inc's (NASDAQ: 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.

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