San Diego, CA -- (SBWIRE) -- 11/18/2014 -- An investor, who purchased shares of AEterna Zentaris Inc. (USA) (NASDAQ:AEZS), filed a lawsuit in the U.S. District Court for the District of New Jersey over alleged violations of Federal Securities Laws by AEterna Zentaris Inc. in connection with certain allegedly false and misleading statements made between October 18, 2012 and November 6, 2014.

Investors who purchased a significant amount of shares of AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) between October 18, 2012 and November 6, 2014, you have certain options and for certain investors are short and strict deadlines running. Deadline: January 12, 2015. NASDAQ:AEZS investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

According to the complaint the plaintiff alleges on behalf of purchasers of AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) common shares between October 18, 2012 and November 6, 2014, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that the Company misstated information about its New Drug Application ("NDA") with the FDA.

AEterna Zentaris Inc. reported that its annual Total Revenue rose from $2.05 million in 2012 to $6.17 million in 2013 and that its Net Loss of $20.41 million in 2012 turned into a Net Income of $6.82 million in 2013.

On October 18, 2012, AEterna Zentaris Inc. announced the Phase III clinical trial results of its drug MACRILEN™ (“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, AEterna Zentaris Inc. 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."

Shares of AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) declined from $3.02 per share in February 2013 to as low as $0.55 per share on November 7, 2014.

On November 14, 2014, NASDAQ:AEZS shares closed at $0.56 per share.

Those who purchased shares of AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com