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MAGENTA THERAPEUTICS, INC.

(MGTA)
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Magenta Therapeutics Gets FDA Clinical-Hold Letter

07/21/2021 | 06:39am EDT

By Michael Dabaie

Magenta Therapeutics Inc. said it received a U.S. Food and Drug Administration clinical hold letter for MGTA-117 in the blood cancers acute myeloid leukemia and myelodysplastic syndrome.

The letter is related to Magenta's investigational new drug application filed in June to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute myeloid leukemia and myelodysplastic syndrome.

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

This doesn't relate to the toxicology or manufacturing of MGTA-117, the company said. Magenta said it has initiated the development of the bioassay and will work closely with the FDA.

"We are actively developing the bioassay requested by the FDA and do not expect significant technical challenges in its completion. We expect to request a 'Type A' meeting in the coming weeks and, if successful in resolving this remaining issue, we would anticipate opening the study in Q4 2021," said Chief Executive Jason Gardner.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

07-21-21 0839ET

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Financials (USD)
Sales 2021 - - -
Net income 2021 -79,6 M - -
Net cash 2021 137 M - -
P/E ratio 2021 -4,93x
Yield 2021 -
Capitalization 413 M 413 M -
EV / Sales 2021 -
EV / Sales 2022 47,3x
Nbr of Employees 67
Free-Float 91,3%
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Mean consensus BUY
Number of Analysts 8
Last Close Price 7,12 $
Average target price 18,43 $
Spread / Average Target 159%
EPS Revisions
Managers and Directors
Jason Gardner President, Chief Executive Officer & Director
Stephen Frank Mahoney COO, CFO, Treasurer & Chief Accounting Officer
Michael W. Bonney Chairman
Lisa M. Olson Chief Scientific Officer & Head-Research
David Nichols Chief Technical Officer
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