INVESTOR ALERT: Class Action Lawsuit Against Aeterna Zentaris Inc. Announced by Law Offices of Howard G. Smith
December 16 2014 - 10:32AM
Business Wire
Law Offices of Howard G. Smith announces that a class action
lawsuit has been filed in the United States District Court for the
District of New Jersey on behalf of purchasers of the securities of
Aeterna Zentaris Inc. (“Aeterna” or the “Company”) (NASDAQ:AEZS)
between October 18, 2012 and November 5, 2014, inclusive (the
“Class Period”). Aeterna is a specialty biopharmaceutical company,
and is developing macimorelin − an orally active small molecule
that stimulates the secretion of growth hormone − as a treatment
for Adult Growth Hormone Deficiency.
The lawsuit alleges that defendants made false and/or misleading
statements and failed to disclose material adverse facts about the
Company’s business, operations and prospects, including that: (1)
the planned analysis of macimorelin’s pivotal clinical trial failed
to meet its primary efficacy endpoint pursuant to the Special
Protocol Assessment agreement letter between the Company and the
FDA; (2) insufficient data existed to confirm that the patients in
the clinical trial were accurately diagnosed with Adult Growth
Hormone Deficiency; (3) a serious cardiac event could have been
attributed to macimorelin; (4) as a result, the FDA would not
approve the New Drug Application for macimorelin in its present
form; and (5), the Company’s statements about its business,
operations and prospects, including statements about macimorelin’s
prospects for FDA approval, were materially false and misleading
and/or lacked a reasonable basis.
On November 6, 2014, the Company revealed that the FDA
determined that the New Drug Application for macimorelin could not
be approved in its present form. The FDA concluded that the planned
analysis of the Company’s pivotal trial did not meet its stated
primary efficacy objective, and “in light of the failed primary
analysis and data deficiencies noted, the clinical trial does not
by itself support the indication.” In addition, the FDA noted that
a serious event of electrocardiogram QT interval prolongation
occurred for which attribution to the drug could not be excluded,
and a dedicated QT interval study would be necessary. Following
this news, Aeterna shares declined nearly 50%, or $0.64 per share,
to close on November 6, 2014, at $0.65 per share, on unusually
heavy volume.
If you are a member of the Class described above, you have until
January 12, 2015, to move the Court to serve as lead plaintiff, if
you meet certain legal requirements. To be a member of the Class
you need not take any action at this time; you may retain counsel
of your choice or take no action and remain an absent member of the
Class. If you wish to learn more about this action, please contact
Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070
Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone
at 215-638-4847, Toll-Free at 888-638-4847, or by email to
howardsmith@howardsmithlaw.com, or visit our website at
http://www.howardsmithlaw.com.
Law Offices of Howard G. SmithHoward G. Smith,
Esquire215-638-4847888-638-4847howardsmith@howardsmithlaw.comwww.howardsmithlaw.com
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