A shareholder's lawsuit filed in federal court in New Jersey is seeking class-action status against a drug company over allegedly misleading statements about the success of a new drug.
Abdul-Hassan Mohammed said Aeterna Zentaris made “false and/or misleading statements” between Oct. 18, 2012, and Nov. 5, 2014, over a new drug application being considered by the Food and Drug Administration. The drug, called Macrilen, was created to treat adult growth hormone deficiency.
On Nov. 6, Aeterna said its new drug application was denied by the FDA because the “pivotal trial” did not meet standards agreed to in a Special Protocol Assessment between the company and the FDA.
Specifically, the lawsuit said Aeterna failed to disclose that the clinical trial didn't meet the standards set by the FDA. It also said patients in the clinical trial may not have been accurately diagnosed with AGHD based on “insufficient data.”
The FDA said that based on these concerns, it wanted the company to conduct another clinical trial. In the wake of the FDA report, shares of the company fell 64 cents per share, or nearly 50 percent of its value, and closed at 65 cents per share on Nov. 6. The lawsuit seeks a class action for any individuals that purchased shares of Aeterna between Oct. 18, 2012, and Nov. 5.
Mohammed's attorney is James E. Cecchi of Carella, Byrne, Cecchi, Olstein, Brody & Angello P.C.
Filed in the United States District Court District of New Jersey, case number 3:14-cv-07225.