Shares of Aeterna Zentaris Inc.
surged almost 14% in premarket trade Thursday, after the biotech said it intends to file a new drug application with the U.S. Food and Drug Administration later this year for its Macrilen growth hormone deficiency treatment. The company said it made the decision after a meeting with the FDA on Wednesday. “Although there can be no assurance of approval of any NDA, we believe that we are now one important step closer to the commercialization of Macrilen(TM) in the U.S., providing a much needed new option and alternative to the ITT (insulin tolerance test),” Chief Executive David Dodd said in a statement. Adult Growth Hormone Deficiency affects about 75,000 adults in the U.S., Canada and Europe, and is mostly caused by damage to the pituitary gland, said the statement. Aeterna shares were down 19% in the year through Wednesday, while the S&P 500
has gained 5.5%.