Published: July 19, 2017 

By

Reporter and editor

Shares of AEterna Zentaris Inc. AEZS, +149.02% more than doubled on heavy volume in afternoon trade Wednesday, after the biotechnology company received a favorable ruling by regulators regarding its treatment for growth hormone deficiency in adults, Macrilen. Volume exploded to 38.9 million shares in recent trade, compared with the full-day average of about 260,000 shares. The company said late Tuesday that the Food and Drug Administration accepted the new drug application (NDA) seeking approval of Macrilen as a "complete response." The FDA granted a Prescription Drug User Fee Act (PDUFA) date of Dec. 30. "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," said Chief Executive David Dodd. The stock has still lost 30% year to date, while the iShares Nasdaq Biotechnology ETF IBB, +1.29% has climbed 20% and the S&P 500 SPX, +0.40% has gained 10%. The FDA had issued a "complete response letter" (CRL) on Nov. 5, 2014 saying it couldn't approve the NDA in its present form because the clinical trial didn't by itself support the indication. The stock closed at a split-adjusted $129.00 the day before the CRL was announced.
  • AEZS
    +1.52 +149.02%
  • IBB
    +4.07 +1.29%
  • SPX
    +9.83 +0.40%