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Shareholder lawsuit filed against Aeterna Zentaris over FDA denial of Macrilen

By Legal News Line | Nov 26, 2014

TRENTON, N.J. (Legal Newsline) - A shareholder's lawsuit recently 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 alleged Aeterna Zentaris made “false and/or misleading statements” between Oct. 18, 2012, and Nov. 5 over a new drug application being considered by the Food and Drug Administration. The drug, 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.

The lawsuit alleges Aeterna failed to disclose that the clinical trial didn't meet the standards set by the FDA. It also alleges 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, the complaint says. In the wake of the FDA report, shares of the company fell 64 cents per share, or approximately 50 percent of its value, and closed at 65 cents per share on Nov. 6. The lawsuit seeks a class action for any individuals who 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.

U.S. District Court for the District of New Jersey case number 3:14-cv-07225.

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