AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) shares are up nearly 8% in pre-market trading Friday, after the drug maker announced that it has resubmitted a new drug application (NDA) to the 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 Chief Executive Officer of the Company stated, “We remain excited about the commercial prospects of Macrilen™. We believe it has the potential to rapidly become the new standard for assessing adult growth hormone deficiency, displacing the insulin tolerance test and capturing the majority of the market quickly following commercial launch. 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.”
On the ratings front, Aeterna Zentaris has been the subject of a number of recent research reports. In a report issued on May 10, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on AEZS, with a price target of $3.00, which implies an upside of 209% from current levels. On May 9, Maxim’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $2.00.
As usual, we recommend taking analyst opinions with a grain of salt. 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 -12.8% and -13.3%, respectively. Ramakanth has a success rate of 31% and is ranked #4529 out of 4600 analysts, while Kolbert has a success rate of 31% and is ranked #4546.
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.