The big shareholder groups in Zafgen, Inc. (NASDAQ:ZFGN) have power over the company. Insiders often own a large chunk...
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BOSTON, June 13, 2019 -- Zafgen, Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel.
Boston-based Zafgen, which focuses on developing therapies for metabolic diseases, announced the receipt of the minutes of a Type A meeting that was held with the FDA regarding a previously imposed clinical hold on its ZGN-1061. ZGN-1061 is a MetAP2 inhibitor that is being evaluated for Type 2 diabetes. The FDA placed a clinical hold on the IND application for the U.S. trial in November 2018, citing possible cardiovascular risk.
Zafgen, Inc. (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 endothelial cells and assessment of tissue factor expression with endothelial cells, and other supportive new assays. The Company is working with FDA to gain alignment on an in vivo animal model to confirm relevant safety margins as a next step toward resolving the clinical hold.
Zafgen, Inc. (ZFGN) and Chondrial Therapeutics, Inc., today announced they have entered into a definitive merger agreement under which Chondrial will become a wholly-owned subsidiary of Zafgen and the stockholders of Chondrial Therapeutics will become the majority owners of Zafgen’s outstanding common stock upon the close of the merger. The proposed merger will result in a combined publicly traded, clinical-stage biopharmaceutical company operating under a new name, Larimar Therapeutics, Inc.
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Zafgen, Inc. (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 presented the full results of its Phase 2 clinical trial for ZGN-1061 in an oral presentation at the American Diabetes Association's 79th Scientific Sessions. Zafgen also presented a poster on data demonstrating that treatment with ZGN-1061 improved measures of glycemic control, including insulin sensitivity and beta-cell function.
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Agreement reached with U.S. FDA on in vivo animal study design and protocol to translate work from novel in vitro assays and establish relevant safety margins Topline data from.
Zafgen and Chondrial Therapeutics previously announced a definitive merger agreement Merger creates clinical-stage company focused on the development of novel protein.
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BOSTON, Aug. 06, 2019 -- Zafgen, Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel.
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Zafgen, Inc. (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 has reached agreement with the U.S. Food and Drug Administration (FDA) on an in vivo animal study design and protocol to establish relevant safety margins for ZGN-1061, its investigational MetAP2 inhibitor in development. The study is designed to translate the data from the Company’s newly developed in vitro assays of human endothelial cells and assessment of tissue factor expression with endothelial cells, along with other supportive assays, as it works toward resolving the previously announced clinical hold. Topline data from the in vivo animal study are expected by the end of 2019.
Evaluation of strategic alternatives ongoing BOSTON, Nov. 06, 2019 -- Zafgen, Inc. (Nasdaq:ZFGN) today reported its third quarter 2019 financial results. In September.