The Rosen Law Firm Announces Investigation of Securities Claims Against Aeterna Zentaris, Inc.

The Rosen Law Firm announces that it is investigating potential securities fraud claims against Aeterna Zentaris, Inc. (NASDAQ:AEZS) resulting from its announcement that the FDA would not approve its New Drug Application (“NDA”).

On October 18, 2012, the Company 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, 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.”

(Emphasis added).

That day, the Company’s stock price fell from $1.29 to $0.65, damaging investors.

The Rosen Law Firm is investigating a securities class action lawsuit on behalf of AEZS investors. If you purchased AEZS stock between October 18, 2012, and November 6, 2014, please visit the website at http://rosenlegal.com to join the class action or obtain more information. You may also contact Jonathan Horne, Esq., or Laurence Rosen, Esq. of The Rosen Law Firm toll free at 866-767-3653 or via e-mail at jhorne@rosenlegal.com or lrosen@rosenlegal.com.

The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.

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