A proposed securities class action lawsuit was recently brought forth against Aeterna Zentaris Inc.
Aeterna Zentaris Inc., based in Quebec, Canada, is a specialty biopharmaceutical firm that develops drug treatments in the fields on endocrinology and oncology. Compounds that have reached various stages of development are included within the company's pipeline.
Rosen Law Firm suit
The Rosen Law Firm announced on Nov. 11, 2014, that it had filed a lawsuit on behalf of purchasers of the specialty biopharmaceutical firm's securities between Oct. 18, 2012 and Nov. 6, 2014. The legal claim involved allegations the firm made misstatements surrounding a New Drug Application filed with the U.S. Food and Drug Administration for Macrilen, used in evaluating adult growth hormone deficiency.
The law firm brought forth this legal action after announcing on Nov. 6, 2014, that it was investigating potential securities fraud claims against Aeterna Zentaris Inc. This inquiry was launched after the firm announced its New Drug Application (NDA) had not received FDA approval. At the time, The Rosen Law Firm indicated it was looking into these claims on the behalf of the specialty biopharmaceutical firm's investors.
Separate securities class action lawsuit
On Nov. 17, 2014, Abraham, Fruchter & Twersky, LLP announced a separate lawsuit involving the company. The law firm declared at the time that it had filed a securities class action against Aeterna Zentaris Inc., as well as some of its senior executives.
The lawsuit was brought forth to represent purchasers of the firm's shares between June 26, 2012 and Nov. 5, 2014, and was filed in the United States District Court for the District of New Jersey. This legal claim alleged that during the class period, defendants made materially false or misleading statements about how well Macrilen worked, as well as its safety.
Phase III clinical trial results
The company conducted Phase III clinical trials pursuant to a Special Protocol Assessment that it worked out with the FDA. The organization announced Phase III clinical trial results for Macrilen on Oct. 18, 2012, saying at the time that the results "confirm [MACRILEN's] potential as possibly the first approved oral diagnostic test for [adult growth hormone deficiency]." After releasing the trial results, Aeterna Zentaris Inc. filed an NDA for Macrilen.
On Nov. 6, 2014, the specialty biopharmaceutical firm announced the FDA had issued a Complete Response Letter, which rejected the company's new drug. In the document, the government agency outlined its concerns.
According to a company statement quoted by The Rosen Law Firm, the letter mentioned "that 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. 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 letter stated that the Company will need to demonstrate the efficacy of macimorelin as a diagnostic test for growth hormone deficiency in a new, confirmatory clinical study," the letter concluded.
Company shares declined to $0.65 each from $1.29 on Nov. 6, 2014, hurting the holdings of shareholders.
Both law firms indicated that if eligible shareholders want to serve as lead plaintiff in this securities class action lawsuit, they must move the court no later than Jan. 12, 2015.