NEW YORK, Nov. 11, 2014 (GLOBE NEWSWIRE) -- The Rosen Law Firm announces that it has filed a class action lawsuit on behalf of purchasers of Aeterna Zentaris, Inc. (Nasdaq:AEZS) securities between October 18, 2012 and November 6, 2014. The lawsuit seeks to recover damages for Aeterna Zentaris investors under the federal securities laws.
To join the AEZS class action, go to the website at http://rosenlegal.com/cases-429.html or call Phillip Kim, Esq. or Jonathan Horne, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or jhorne@rosenlegal.com for information on the class action. The suit is pending in U.S. District Court for the District of New Jersey.
NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. YOU MAY RETAIN COUNSEL OF YOUR CHOICE.
According to the lawsuit, the Company misstated information about its New Drug Application ("NDA") with the FDA. On October 18, 2012, the Company announced the Phase III clinical trial results of its drug MACRILEN™ stating that the results "confirm [MACRILEN's] potential as possibly the first approved oral diagnostic test for [adult growth hormone deficiency]." The Phase III trials were conducted pursuant to a Special Protocol Assessment that was agreed upon with the FDA. The Company then filed an NDA for MACRILEN.
On November 6, 2014, the Company announced that the FDA would not approve the Company's MACRILEN NDA, as it had received a Complete Response Letter ("CRL"). The Company stated that the FDA's concerns were:
"[T]hat the planned analysis of the Company's pivotal trial did not meet its stated primary efficacy objective as agreed to in the Special Protocol Assessment agreement letter between the Company and the FDA. The CRL further mentioned issues related to the lack of complete and verifiable source data for determining whether patients were accurately diagnosed with AGHD. The FDA concluded that, "in light of the failed primary analysis and data deficiencies noted, the clinical trial does not by itself support the indication." To address the deficiencies identified above, the CRL states that the Company will need to demonstrate the efficacy of macimorelin as a diagnostic test for growth hormone deficiency in a new, confirmatory clinical study." That day, the Company's stock price fell from $1.29 to $0.65, damaging investors.
A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than January 12, 2015. If you wish to join the litigation go to http://rosenlegal.com/cases-429.html or to discuss your rights or interests regarding this class action, please contact, Phillip Kim, Esq. of The Rosen Law Firm toll free at 866-767-3653 or via e-mail at pkim@rosenlegal.com.
The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.