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You must submit the settlement Proof form in order to participate in this settlement. There is a strict deadline of January 26, 2021 by which all claims must be submitted. The instructions for submitting are included in the Proof and the Notice files. DO NOT SEND THE FORMS TO THE SHAREHOLDERS FOUNDATION, INC.
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Lawsuit Overview
Settlement Overview
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June 1, 2021 - The court granted final approval of the settlement.
September 29, 2020 - The court preliminarily approved the settlement.
July 22,2020 - A stipulation and agreement of settlement was filed by the parties.
March 2, 2016 - The court granted in part and denied in part defendants' motion to dismiss.
November 11, 2015 - A motion to dismiss the second amended complaint was filed.
October 14, 2015 - A second amended complaint was filed.
September 16, 2015 - The court granted defendants' motion to dismiss with leave to amend.
May 26, 2015 - A motion to dismiss the amended complaint was filed.
April 10, 2015 - The lead plaintiffs filed an amended complaint was filed.
November 14, 2014 - An investor in shares of AEterna Zentaris Inc (USA) (NASDAQ: AEZS) filed a lawsuit in the U.S. District Court for the District of New Jersey over alleged violations of Federal Securities Laws by AEterna Zentaris Inc in connection with certain allegedly false and misleading statements made between June 26, 2012 and November 5, 2014.
According to the complaint the plaintiff alleges on behalf of purchasers of AEterna Zentaris Inc (USA) (NASDAQ: AEZS) common shares between June 26, 2012 and November 5, 2014, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that AEterna Zentaris Inc misstated information about its New Drug Application ( NDA ) with the FDA. AEterna Zentaris Inc reported that its annual Total Revenue rose from $2.05 million in 2012 to $6.17 million in 2013 and that its Net Loss of $20.41 million in 2012 turned into a Net Income of $6.82 million in 2013.
On October 18, 2012, AEterna Zentaris Inc 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. AEterna Zentaris Inc then filed an NDA for MACRILEN.
On November 6, 2014, AEterna Zentaris Inc announced that the FDA would not approve the Company’s MACRILEN NDA, as it had received a Complete Response Letter (“CRL”). AEterna Zentaris Inc stated that the FDA’s concerns were: [T]hat the planned analysis of AEterna Zentaris Inc'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 AEterna Zentaris Inc will need to demonstrate the efficacy of macimorelin as a diagnostic test for growth hormone deficiency in a new, confirmatory clinical study. Shares of AEterna Zentaris Inc (USA) (NASDAQ: AEZS) declined from $3.02 per share in February 2013 to as low as $0.55 per share on November 7, 2014.
On November 14, 2014, AEterna Zentaris Inc (NASDAQ: AEZS) shares closed at $0.56 per share.