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Fennec Pharmaceuticals Inc.

Company NameFennec Pharmaceuticals Inc.
Stock SymbolFENC
Class PeriodMay 28, 2021 to November 26, 2021
Lead Plaintiff Motion DeadlineApril 11, 2022

On November 29, 2021, before the market opened, Fennec issued a press release announcing that it expects to receive a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted PEDMARK New Drug Application (“NDA”). Specifically, Fennec stated that the FDA had indicated that, “following a recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, deficiencies have been identified.”

On this news, Fennec’s stock fell $4.86, or 50.4%, to close at $4.78 per share on November 29, 2021, thereby injuring investors.

The complaint alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Fennec had not successfully remediated, and overstated its efforts to remediate, issues with the manufacturing facility of its drug product manufacturer for PEDMARK; (2) as a result, the FDA was unlikely to approve the Resubmitted PEDMARK NDA; (3) accordingly, the regulatory and commercial prospects of the Resubmitted PEDMARK NDA were overstated; and (4) as a result of the foregoing, Defendants’ public statements were materially false and misleading at all relevant times.

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