AEterna Zentaris Inc. (NASDAQ: AEZS) moved skyward Thursday after the company reported the FDA approval of Macrilen for diagnosis of adult growth hormone deficiency.
The Charleston, South Carolina-based company, a specialty biopharmaceutical company engaged in developing and commercializing pharmaceutical therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Macrilen™ (macimorelin), an orally available ghrelin agonist, to be used in the diagnosis of patients with 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.
Said CEO Michael Ward, “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.
“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.”
Macrilen (macimorelin) stimulates the secretion of growth hormone from the pituitary gland into the circulatory system. Stimulated growth hormone levels are measured in four blood samples over ninety minutes after oral administration of Macrilen™ (macimorelin) for the assessment of AGHD.
AEZS says it intends to make Macrilen™ (macimorelin) available commercially in the United States during the first quarter of 2018.
Shares in AEZS catapulted $1.14, or 56.7%, to $3.15, within a 52-week trading range of 78 cents to $4.25.
