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Fennec Pharmaceuticals Inc.

Company NameFennec Pharmaceuticals Inc.
Stock SymbolFENC
Class PeriodFebruary 11, 2020 to August 10, 2020
Lead Plaintiff Motion DeadlineNovember 02, 2020

On August 11, 2020, before the market opened, Fennec disclosed that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding 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.”

On this news, the Company’s share price fell $3.51, or 34%, 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 false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the manufacturing facilities for PEDMARK, the Company’s sole product candidate, did not comply with current good manufacturing practices; (2) that, as a result, regulatory approval for PEDMARK was reasonably likely to be delayed; and (3) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

 

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