AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) announced that it has been notified by the U.S. Food and Drug Administration (“FDA”), that the Company’s New Drug Application (“NDA”) seeking approval of Macrilen™ (macimorelin) for the evaluation of growth hormone deficiency in adults (“AGHD”) has been accepted as a complete response to the FDA’s November 5, 2014 Complete Response Letter and granted a PDUFA date of December 30, 2017.
David A. Dodd, President and Chief Executive Officer of the Company stated, “We are pleased that the FDA has formally accepted our resubmitted NDA and that it is under active review with an end-of-year PDUFA date. We remain confident that the FDA will approve our NDA and, therefore, we are moving forward with our preparations to launch the product in the first quarter of 2018.”
The Company also announces that Mr. Kenneth Newport is no longer a member of the Board of Directors effective as of July 12, 2017.
Shares of Aeterna Zentaris are up nearly 19% to $1.21 in after-hours trading Tuesday. AEZS has a 1-year high of $5.59 and a 1-year low of $0.78. The stock’s 50-day moving average is $1.02 and its 200-day moving average is $2.18.
On the ratings front, AEZS has been the subject of a number of recent research reports. In a report issued on July 5, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on AEZS, with a price target of $3.00, which implies an upside of 194% from current levels. On June 30, Maxim’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $2.00.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Swayampakula Ramakanth and Jason Kolbert have a yearly average loss of -9.4% and -11.3% respectively. Ramakanth has a success rate of 33% and is ranked #4499 out of 4599 analysts, while Kolbert has a success rate of 32% and is ranked #4548.
Æterna Zentaris, Inc. operates as a specialty biopharmaceutical company that is engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. The company’s pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. It focuses on the development of Perifosine, Cetrotide, Ozarelix, AEZS-108 and AEZS-130.