AEterna Zentaris Inc. (NASDAQ: AEZS) shares more than doubled in price Wednesday, after the company got word from the U.S. Food and Drug Administration.
The company was notified by the 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 Prescription Drug User Fee Act (PDUFA) date of December 30, 2017.
Macimorelin is an orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this patented compound and has significant patent protection left.
The Company’s U.S. composition of matter patent expires in 2022 and its U.S. utility patent runs through 2027. The Company proposes, subject to FDA approval, to market macimorelin under the tradename Macrilen™.
AGHD affects approximately 75,000 adults across the U.S., Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status.
Said Aeterna CEO David Dodd, “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.”
Aeterna Zentaris – based in Quebec but with U.S. headquarters in Charleston, South Carolina -- is a specialty biopharmaceutical company engaged in developing and commercializing novel pharmaceutical therapies.
AEZS shares rocketed $1.57, or 153.9%, to $2.59.
