Aeterna Zentaris Inc. said a shareholder lawsuit against the company regarding its hormone deficiency drug Macrilen received class certification.
The U.S. District Court for the District of New Jersey granted class certification to the lawsuit, filed against the company and certain of its current and former officers. The shareholders sued the company for allegedly making false statements regarding the safety and efficacy of Macrilen and its prospects for approval by the U.S. Food and Drug Administration.
The FDA rejected the new drug application for Macrilen, also known as macimorelin, in 2014, and Aeterna resubmitted the application in July 2017. In December 2017, the regulator approved the drug for use in the diagnosis of adult growth hormone deficiency.
The Summerville, S.C.-based company said it intends to defend the lawsuit and believes that substantially all costs for its defense will be covered by insurers. The company also said that since it cannot predict the suit's outcome or estimate any possible loss, it has not recorded any liability related to the lawsuit.
