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0.127450980392157 0.137254901960784 0.176470588235294 0.147058823529412 0.313725490196078 0.323529411764706 0.411764705882353 0.441176470588235
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NDA for Macrilen™ for the Evaluation of Growth Hormone Deficiency in Adults Granted December 30, 2017 PDUFA Date

AETERNA ZENTARIS (AEZS)  More Company Research Source: Business Wire
Last aeterna zentaris earnings: 5/7 04:15 pm Check Earnings Report
US:NASDAQ Investor Relations: zentaris.com
PDF CHARLESTON, S.C.--(BUSINESS WIRE)-- Aeterna Zentaris Inc. (NASDAQ: AEZS)(TSX: AEZS) (the “Company”) today announced that it has been notified by the U.S. Food and Drug Administration (“FDA”), that the Company’s New Drug Application (“NDA”) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (“AGHD”) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017. David A. Dodd, President and Chief Executive Officer of the Company stated, “We are pleased that the FDA has formally accepted our resubmitted NDA and that it is under active review with an end-of-year PDUFA date. We remain confident that the FDA will approve our NDA and, therefore, we are moving forward with our preparations to launch the product in the first quarter of 2018.” The Company also announces that Mr [Read more]

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