Canadian biopharmaceutical firm Aeterna Zentaris faces a putative class action by shareholders over a drop in its stock price after the U.S. Food and Drug Administration rejected its application for approval of a key product.
The suit said the company’s stock price dropped 50 percent in one day following the FDA’s Nov. 6, 2014, ruling denying approval of the new drug application for Macrilen, Aeterna Zentaris’ adult growth hormone deficiency (AGHD) diagnostic drug. The application’s rejection means the company will have to conduct a new clinical study to address problems in its Phase 3 trial, which did not meet objectives outlined in the company’s special protocol assessment with the FDA, the suit says.
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