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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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November 20, 2014
07:34 EDTAEZSAeterna Zentaris adds center to Phase 3 trial in endometrial cancer
Aeterna Zentaris announced the opening of a new clinical site at the Hollings Cancer Center of the Medical University of South Carolina in Charleston, South Carolina, for the company's ongoing multinational, pivotal ZoptEC Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer. Furthermore, the company announced that patient recruitment for this trial now stands at over 320 patients out of a projected total of 500 patients. Patient recruitment is in line to secure expected interim analysis in H1 2015, the company said.

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