AEterna Zentaris Inc. (USA) (AEZS) Shares on the Rise Amid NDA Submission Plans


AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) investors are overwhelmingly excited today after the drug maker announced that following its meeting with thef FDA, on March 29, 2017, it intends to file a new drug application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD).

AEterna shares reacted to the news, rising 10% to $3.25 in pre-market trading Thursday.

Commenting on the meeting, Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “During our meeting with the FDA, the Agency stated that the clinical studies we performed with respect to Macrilen™ address the prior deficiencies mentioned in the November 2014 complete response letter. This conclusion paves the way for our re-submission of an NDA for Macrilen™, which we expect to file in the third quarter of this year. While indicating that our conclusions regarding the performance of Macrilen™ are review issues subject to an examination of the complete data set, the Agency indicated that the summary data we submitted prior to the meeting appear to support the propositions we advanced. Most importantly, the FDA specified the additional statistical analysis of existing data that would be required to further support our conclusions. We expect that we can provide those data in a compelling fashion and demonstrate that Macrilen™ is a robust, repeatable test, demonstrating adequate sensitivity and specificity and that the performance of the product would be improved by utilizing a more appropriate cut-off point.”

David A. Dodd, President and Chief Executive Officer of the Company stated, “We were encouraged by our dialogue with the FDA regarding Macrilen™. The Agency provided very helpful guidance to us that should help us in the registration process. Of course, the FDA will thoroughly review all data we provide with our NDA and make a decision regarding the approval of the product after doing so. Although there can be no assurance of approval of any NDA, we believe that we are now one important step closer to the commercialization of Macrilen™ in the U.S., providing a much needed new option and alternative to the ITT.”

Shares of Aeterna Zentaris closed yesterday at $2.90, down $0.05 or -1.69%. AEZS has a 1-year high of $5.59 and a 1-year low of $2.35. The stock’s 50-day moving average is $3.03 and its 200-day moving average is $3.35.

On the ratings front, AEZS has been the subject of a number of recent research reports. In a report issued on March 16, Maxim analyst Jason Kolbert reiterated a Buy rating on the stock, with a price target of $11, which implies an upside of 279% from current levels. On January 6, Canaccord’s Neil Maruoka reiterated a Buy rating on the stock and has a price target of $5.50.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Neil Maruoka have a yearly average loss of -10.7% and -3.0% respectively. Kolbert has a success rate of 33% and is ranked #4489 out of 4555 analysts, while Maruoka has a success rate of 43% and is ranked #4099.

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. 

 

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