AEterna Zentaris Inc. (USA) (AEZS) Investors Celebrate FDA Approval; Shares Skyrocket


Investors love biotech stocks for the lottery ticket-like returns they can offer if a company strikes medical gold or wins the regulator’s bless. Case in point: AEterna Zentaris Inc. (USA) (NASDAQ:AEZS), whose shares are jumping nearly 60% in after-hours trading Wednesday.

The reason? The drug maker won FDA approval for Macrilen™ (macimorelin), the company’s product candidate for the diagnosis of Adult Growth Hormone Deficiency (AGHD). The Company estimates that approximately 60,000 tests for suspected AGHD are being conducted each year across the United States, Canada and Europe.

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“Aeterna Zentaris is proud of our commitment to patients with suspected AGHD and to the endocrinology community who we are confident will welcome an easier safe and effective oral diagnostic tool,” said Michael V. Ward, Chief Executive Officer, Aeterna Zentaris. “In the absence of an FDA-approved diagnostic test for AGHD, Macrilen™ fills an important gap and addresses a medical need for a convenient test that will better serve patients and health providers.”

“Clinical studies have demonstrated that growth hormone stimulation testing for AGHD with oral Macrilen™ (macimorelin) is reliable, well-tolerated, reproducible, safe and a much simpler test to conduct than currently available options,” said Kevin Yuen, MD, clinical investigator and neuroendocrinologist, Barrow Neurological Institute, and medical director of the Barrow Neuroendocrinology Clinic, Phoenix, Arizona. “The availability of Macrilen™ (macimorelin) will greatly relieve the burden of endocrinologists in reliably and accurately diagnosing AGHD.”

On the ratings front, AEZS stock has been the subject of a number of recent research reports. In a report issued on November 29, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on AEZS, with a price target of $3.00, which represents a potential upside of 49% from today’s closing price. On November 28, Maxim Group’s Jason Kolbert assigned a Buy rating to the stock and has a price target of $4.00

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 -6.2% and -8.1% respectively. Ramakanth has a success rate of 33% and is ranked #4567 out of 4725 analysts, while Kolbert has a success rate of 33% and is ranked #4651.

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