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AEterna Zentaris's stock more than doubles on heavy volume after favorable FDA ruling: MarketWatch || Biotechnology -July 19, 2017
Published: July 19, 2017
Reporter and editor
Shares of AEterna Zentaris Inc.
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
has climbed 20% and the S&P 500
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.