Zafgen Announces Regulatory Update on ZGN-1061
ZAFGEN INC (ZFGN)
Last zafgen inc earnings: 3/5 04:05 pm
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Source: GlobeNewswire
Received FDA Type A meeting minutes related to previously announced clinical hold FDA acknowledged newly developed in vitro assays of human plasma coagulation and tissue factor expression qualitatively differentiate ZGN-1061 Company is working with FDA to translate in vitro data and confirm relevant safety margins in an in vivo model Additionally, Zafgen is exploring a second IND for ZGN-1061 in a population with higher unmet medical need BOSTON, May 30, 2019 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel therapies for patients affected by a range of metabolic diseases, today announced the receipt of minutes from its Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the clinical hold for ZGN-1061. Zafgen provided key new data in advance of the meeting, including newly developed in vitro assays of human plasma coagulation using endo
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