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January 6, 2014
12:01 EDTAEZSAeterna Zentaris NDA filing for macimorelin acetate accepted by FDA
Aeterna Zentaris announced that the Food and Drug Administration has accepted for filing the company's New Drug Application for its ghrelin agonist, macimorelin acetate, in Adult Growth Hormone Deficiency. The company's NDA, submitted on November 5, 2013, seeks approval for the commercialization of macimorelin acetate as the first orally-administered product that induces growth hormone release to evaluate AGHD. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review, the company said.
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May 26, 2015
07:32 EDTAEZSAeterna Zentaris says Macrilen study in AGHD meets EMA study-design expectations
Aeterna Zentaris announced that it has received written scientific advice from the European Medicines Agency regarding the further development plan, including the study design, for the new confirmatory Phase 3 clinical study of Macrilen for use in evaluating adult growth hormone deficiency, following a Scientific Advice Meeting that was held earlier this month. As a result of the advice, the company believes that the confirmatory Phase 3 study that was discussed with the U.S. Food & Drug Administration last March, meets the EMA's study-design expectations. "We are committed to moving forward swiftly with the development of Macrilen in AGHD. We believe that completion of the confirmatory Phase 3 study and the QT study will take 15 to18 months and will require a combined expenditure of between $5M-$6M. We have the resources necessary to bring this product to market and intend to do so as rapidly as possible, pending regulatory approvals," said David Dodd, Chairman and CEO.

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