Aeterna Zentaris (AEZS) to Pursue FDA Registration of Macrilen
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Aeterna Zentaris Announces Plans to Pursue FDA Registration of Macrilen™
February 13, 2017 7:30 AM ESTCHARLESTON, S.C.--(BUSINESS WIRE)-- Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the Company) today announced that, following a comprehensive review of data obtained from the confirmatory Phase 3 clinical trial of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD), using the insulin tolerance test (the ITT) as a comparator, it concluded that Macrilen demonstrated performance supportive of achieving registration with the U.S. Food and Drug Administration (the FDA). The FDA has agreed to consider the Companys conclusions during a Type A meeting, which is currently being scheduled.... More
