The Rosen Law Firm Announces Investigation of Securities Claims Against Aeterna Zentaris, Inc.
November 06 2014 - 7:02PM
Business Wire
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.
Attorney Advertising. Prior results do not guarantee a similar
outcome.
The Rosen Law Firm P.A.Laurence Rosen, Esq.Jonathan Horne,
Esq.275 Madison Avenue 34th FloorNew York, New York 10016Tel:
212-686-1060Weekend Tel: 917-562-8616Toll Free: 1-866-767-3653Fax:
212-202-3827lrosen@rosenlegal.comjhorne@rosenlegal.comwww.rosenlegal.com
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