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FDA OKs Aeterna Zentaris' Macrilen for diagnosis of adult growth hormone deficiency; shares up 53% after hours

  • Aeterna Zentaris (NASDAQ:AEZS) is up 53% after hours on robust volume in response to the FDA approval of Macrilen (macimorelin) to be used in the diagnosis of adult growth hormone deficiency (AGHD).
  • Macrilen stimulates the secretion of growth hormone from the pituitary gland. Stimulated levels are measured in four blood samples over 90 minutes after ingesting the ghrelin agonist.
  • The company estimates that ~60K tests for suspected AGHD are performed each year in the U.S., Canada and Europe.
  • Commercial launch in the U.S. will commence next quarter.

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