Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that a class action lawsuit has been filed in the United States District Court for the Middle District of North Carolina on behalf of investors that purchased Fennec Pharmaceuticals, Inc. (NASDAQ: FENC) securities between February 11, 2020 and August 10, 2020 (the "Class Period"). Investors have until November 2, 2020 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Fennec is a biopharmaceutical company that purportedly focuses on the development of PEDMARK, a sodium thiosulfate anhydrous injection, for the prevention of platinum-induced ototoxicity in pediatric cancer patients.
On August 11, 2020, 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 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.
The complaint, filed on September 3, 2020, 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.
If you purchased Fennec securities during the Class Period and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Melissa Fortunato, Marion Passmore, or Brandon Walker by email at email@example.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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