AEterna Zentaris Inc. (USA) (NASDAQ:AEZS)
Shares of AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) more than doubled in value after the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for Macrilen. The stock ended the day at $2.34 a share after rallying by 129.41% on volumes exceeding 38.9 million shares.
AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) is a specialty biopharmaceutical company focused on the development and commercialization of novel pharmaceutical therapies. Its principal product candidates are Zoptrex in oncology and Macrilen in endocrinology. Both drugs are currently in Phase III development.
AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) made a NDA resubmission for Macrilen last month after receiving a Complete Response letter in November of 2014. The letter laid out the FDA’s request for the company to carry out additional clinical trials on the drug, pending its review as a novel treatment for growth hormone deficiency in adults.
“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,” said CEO, David A. Dodd.
Macrilen Approval Odds
The FDA review period for the drug is six months long which sets the stage for approval early next year or late this year. AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) remains confident on Macrilen achieving regulatory approval for assessing adult growth hormone deficiency. If approved, it will be the first and only FDA approved drug for assessing AGHD.
AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) has already started to develop a commercialization infrastructure for Macrilen in anticipation of FDA approval. The company remains confident of launching Macrilen in the first quarter of 2018.
Macrilen is a ghrelin agonist oral active molecule designed to stimulate the secretion of growth hormone. The candidate drug has already achieved orphan drug designation for the diagnosis of AGHD. AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) owns rights to the patented compound.
AGHD is a medical condition that affects 75,000 adults across the U.S, Canada and Europe. The condition is mostly caused by damage to the pituitary gland characterized by a reduction in bone mineral density, and lean body mass.
In the wake of the NDA milestone, Maxim analyst, Jason Kolbert has initiated coverage of AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) stock with a buy rating. The analyst currently has a $4 share price target on the stock.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Marc has a degree in economics and a MSc. in Finance. Marc worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.