Fennec Pharmaceuticals Inc.

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.