Fennec Pharmaceuticals Inc.
|Company Name||Fennec Pharmaceuticals Inc.|
|Class Period||February 11, 2020 to August 10, 2020|
|Lead Plaintiff Motion Deadline||November 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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