LOS ANGELES--(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 email@example.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 firstname.lastname@example.org, 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.
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