Magenta Therapeutics Inc

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Products, Regulatory

Magenta Therapeutics Receives Clinical Hold Letter Related To Trial Of MGTA-117

Published: 07/21/2021 12:41 GMT
Magenta Therapeutics Inc (MGTA) - Magenta Therapeutics Announces Update on U.S. FDA Investigational New Drug Application for Mgta-117 in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome.
Magenta Therapeutics Inc - Received Clinical Hold Letter From U.S. FDA Related to Ind Filed to Initiate a Phase 1/2 Clinical Trial of Mgta-117.
Magenta Therapeutics - FDA is Requiring Co Develop Additional Bioassay to Be Used With Pk/pd Model to Inform Dose Escalation Decisions in Addition to Safety Monitoring.
Magenta Therapeutics - Initiated Development of Bioassay & Intends to Work Closely With FDA to Determine Application of Bioassay for Dose Escalation.
Magenta Therapeutics - Ended Q2 2021 With More Than $200 Million in Cash & Anticipates Being Able to Execute on Existing Plans.
Magenta Therapeutics- Expect to Request 'type A' Meeting With U.S. FDA in Coming Weeks.
Magenta Therapeutics Inc - If Successful in Resolving Remaining Issue, We Would Anticipate Opening Study in Q4 2021.