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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.
News For AEZS From The Last 14 Days
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April 27, 2015
16:22 EDTAEZSAeterna Zentaris reports DSMB recommends continuation of Phase 3 ZoptEC study
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April 16, 2015
07:37 EDTAEZSAeterna Zentaris files additional patent application for zoptarelin doxorubicin
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April 15, 2015
07:41 EDTAEZSEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 14, 2015
10:01 EDTAEZSOn The Fly: Analyst Upgrade Summary
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07:08 EDTAEZSAeterna Zentaris upgraded to Buy from Neutral at H.C. Wainwright
H.C. Wainwright upgraded Aeterna Zentaris to Buy with a $1.25 price target following the successful meeting with the FDA for a new Phase 3 trial of Macrilen and a separate, thorough QT study to address issues raised by the Complete Response Letter in November 2014.
April 13, 2015
07:34 EDTAEZSAeterna Zentaris plans to conduct new Phase 3 clinical study of Macrilen
Aeterna Zentaris announced plans to conduct a new, confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen, or macimorelin, a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency, as well as a dedicated thorough QT study to evaluate the effect of Macrilen on myocardial repolarization. This decision follows a positive and helpful meeting with the FDA regarding its New Drug Application for Macrilen. The Company's goal is to conduct a Phase 3 study that will satisfy the registration requirements of the European Medicines Agency as well as the FDA. The Company expects to receive comments from the EMA regarding the study design during a Scientific Advice Meeting in early May.

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