Before the market opened, on August 11, 2020, Fennec disclosed that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) in regards to the company’s New Drug Application (“NDA”) for PEDMARK. According to the CRL, “after recent completion of a pre-approval inspection of the manufacturing facility of [Fennec’s] drug product manufacturer, the FDA identified deficiencies resulting in a Form 483, which is a list of conditions or practices that are required to be resolved prior to the approval of PEDMARK.”
The company’s share price fell $3.51, or 34%, on this news, to close at $6.66 per share on August 11, 2020, thereby injuring investors.
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially misleading and/or false statements, as well as failed to disclose facts about the company’s business, operations, and prospects that were materially adverse. Specifically, Defendants failed to disclose to investors: (1) that PEDMARK’s manufacturing facilities, the company’s sole product candidate, was not in compliance with current good manufacturing practices; (2) that, as a result, PEDMARK’s regulatory approval was reasonably likely to be delayed; and (3) that, Defendants’ positive statements about the company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis, as a result of the foregoing.
Fennec Pharmaceuticals Inc.
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