INVESTOR ALERT: Investigation of Aeterna Zentaris, Inc. Announced by Glancy Binkow & Goldberg LLP
November 10 2014 - 10:32AM
Business Wire
Glancy Binkow & Goldberg LLP announces that it is
investigating potential claims on behalf of investors of Aeterna
Zentaris, Inc. (“Aeterna Zentaris” or the “Company”)
(NASDAQ:AEZS) concerning possible violations of federal securities
laws. The investigation is focused on the Company’s operations and
financial prospects.
Please contact Lesley Portnoy at (310) 201-9150, or at
shareholders@glancylaw.com to discuss this matter. If you inquire
by email, please include your mailing address, telephone number and
number of shares purchased.
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 the Company’s New Drug Application (NDA) for
MacrilenTM (macimorelin), an orally-active ghrelin agonist, for use
in evaluating adult growth hormone deficiency. 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.
According to the Company, the FDA’s review of the application
has determined that the NDA cannot be approved in its present form.
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 Aeterna Zentaris shares, if you have
information or would like to learn more about these claims, or have
any questions concerning this announcement or your rights or
interests with respect to these matters, please contact Lesley
Portnoy, Esquire, of Glancy Binkow & Goldberg LLP, 1925 Century
Park East, Suite 2100, Los Angeles, California 90067 at (310)
201-9150, Toll Free at (888) 773-9224, by e-mail to
shareholders@glancylaw.com, or visit our website at
http://www.glancylaw.com. If you inquire by email please include
your mailing address, telephone number and number of shares
purchased.
This press release may be considered Attorney Advertising in
some jurisdictions under the applicable law and ethical rules.
Glancy Binkow & Goldberg LLP, Los Angeles, CALesley
Portnoy(310) 201-9150(888) 773-9224shareholders@glancylaw.comwww.glancylaw.com
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