SHAREHOLDER ALERT: Investigation on Behalf of Aeterna Zentaris, Inc. Investors Announced by Law Offices of Howard G. Smith
November 07 2014 - 5:08PM
Business Wire
Law Offices of Howard G. Smith announces that it is
investigating potential claims on behalf of investors of Aeterna
Zentaris, Inc. (“Aeterna Zentaris” or the “Company”) (NASDAQ:AEZS).
The investigation concerns possible violations of federal
securities laws and focuses on certain statements issued by Aeterna
Zentaris concerning the Company’s operations and business
prospects.
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in the development and commercialization of novel
treatments in oncology and endocrinology. The investigation is
related to the Company’s November 6, 2014, announcement that it has
received a Complete Response Letter from the U.S. Food and Drug
Administration for Aeterna Zentaris’ New Drug Application (NDA) for
Macrilen™ (macimorelin), an orally-active ghrelin agonist, for use
in evaluating adult growth hormone deficiency.
According to the Company, the FDA’s review of the application
has determined that the NDA cannot be approved in its present form.
Among other things, the Complete Response Letter notes: (1) 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; and (2), issues related to the lack of complete and verifiable
source data for determining whether patients were accurately
diagnosed with adult growth hormone deficiency. In light of the
failed primary analysis and data deficiencies noted, the FDA
concluded that “the clinical trial does not by itself support the
indication,” and the Company will need to demonstrate the
drug’s efficacy in a new, confirmatory clinical study.
If you purchased shares of Aeterna Zentaris, if you have
information or would like to learn more about these claims, or if
you have any questions concerning this announcement or your rights
or interests with respect to these matters, 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
www.howardsmithlaw.com.
Law Offices of Howard G. SmithHoward G. Smith, Esquire(215)
638-4847(888)
638-4847howardsmith@howardsmithlaw.comwww.howardsmithlaw.com
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