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Zafgen To Explore Strategic Options After FDA Hold On ZGN-1061 - Quick Facts

Biopharmaceutical company Zafgen, Inc. (ZFGN) announced Thursday plans to explore strategic options to maximize shareholder value including but not limited to, an acquisition, merger, business combination, in-licensing, or other strategic transaction involving the Company or its assets.

A transaction committee has been formed within the Board of Directors for exploring potential strategic alternatives.

The company is taking this action based on the preliminary results from its ongoing nonclinical study to translate in vitro differentiation results into an in vivo model system. The company believes there is low probability of resolving the clinical hold in the near-term.

Based on preliminary results from this study reviewed this week, Zafgen does not presently expect the data to warrant resolution of the clinical hold for ZGN-1061, which is its investigational MetAP2 inhibitor in development.

In November 2018, the FDA has placed a clinical hold on the Investigational New Drug Application for the Company's first U.S. clinical trial of ZGN-1061 for the treatment of type 2 diabetes, citing the possibility of cardiovascular (CV) safety risk.

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