Zafgen Provides Update on Investigational New Drug Application for ZGN-1061
ZAFGEN INC (ZFGN)
Last zafgen inc earnings: 3/5 04:05 pm
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Source: GlobeNewswire
BOSTON, Nov. 26, 2018 (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 that the Company received a letter last week from the U.S. Food and Drug Administration (FDA) placing a clinical hold on the Investigational New Drug Application (IND) for its first U.S. clinical trial of ZGN-1061, the Company’s second-generation, investigational MetAP2 inhibitor currently in development for the treatment of type 2 diabetes. The FDA cited the possibility of cardiovascular (CV) safety risk based on the Company’s prior compound and outlined multiple potential paths for moving forward, including nonclinical or clinical options, to address these concerns in the ongoing development of ZGN-1061. The Company plans to assess these options and request a Type A meeting with the Agency to discuss next step
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