Aeterna Zentaris (NASDAQ: AEZS) shares are higher after the company this morning said that is has resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Macrilen™ for the evaluation of growth hormone deficiency in adults (AGHD). The resubmission comes ahead of the company’s previously announced schedule, and the company anticipates an FDA review period of six months. “We anticipate successful FDA approval and, as a result, we continue to build our commercial organization and infrastructure in preparation for the earliest possible launch of Macrilen™. Our focus is to be prepared to launch the product in the first quarter of 2018,” Aeterna Zentaris president and CEO David A. Dodd stated in the news release.
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About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel pharmaceutical therapies. The company is engaged in drug development activities and in the promotion of products for others. Aeterna recently completed phase 3 studies of two internally developed compounds. The focus of the business development efforts is the acquisition of licenses to products that are relevant to Aeterna’s therapeutic areas of focus. The company also intends to license out certain commercial rights of internally developed products to licensees in non-U.S. territories where such out-licensing would enable Aeterna to ensure development, registration and launch of its product candidates. The company’s goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of its product portfolio, achieving successful commercial presence and growth, while consistently delivering value to its shareholders, employees and the medical providers and patients who will benefit from these products. For more information, visit www.aezsinc.com.
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