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Stockreport

Aeterna Zentaris Resubmits NDA for Macrilen™ for the Evaluation of Growth Hormone Deficiency in Adults

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 resubmitted a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”), seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (“AGHD”). Commenting on the resubmission, Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “I am pleased to announce that we re-submitted the NDA for Macrilen™ today. I would like to thank my team for their efforts in getting us to this point ahead of our previously announced schedule. We believe that the FDA review period of our NDA will be up to six months, setting the stage for potential approval of the product late in 2017 or early in 2018. If the product is approved, it will be the only FDA-approved drug for assessing AGHD.” David A. Dodd, President and C [Read more]

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