Fennec Pharmaceuticals Inc. Class Action Lawsuit
- Company Name
- Fennec Pharmaceuticals Inc.
- Stock Symbol
- Class Period
- February 11, 2020 to August 10, 2020
- Middle District of North Carolina
The Fennec Pharmaceuticals Inc. class action lawsuit charges Fennec Pharmaceuticals, its CEO Rostislav Raykov and CFO Robert Andrade with violations of the Securities Exchange Act of 1934 and seeks to represent purchasers of Fennec Pharmaceuticals securities between February 11, 2020 and August 10, 2020, inclusive (the “Class Period”). The Fennec Pharmaceuticals class action lawsuit was commenced on September 3, 2020 in the Middle District of North Carolina and is captioned Chapman v. Fennec Pharmaceuticals Inc., No. 20-cv-00812.
Fennec Pharmaceuticals is a biopharmaceutical company focused on the development of PEDMARK, a sodium thiosulfate anhydrous injection for the prevention of hearing loss associated with certain chemotherapy treatments in pediatric cancer patients.
The Fennec Pharmaceuticals class action lawsuit alleges that during the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) the manufacturing facilities for PEDMARK, Fennec Pharmaceuticals’ sole product candidate, did not comply with current good manufacturing practices; (2) as a result, regulatory approval for PEDMARK was reasonably likely to be delayed; and (3) as a result of the foregoing, defendants’ positive statements about Fennec Pharmaceuticals’ business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
On August 11, 2020, Fennec Pharmaceuticals disclosed that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding Fennec Pharmaceuticals’ New Drug Application for PEDMARK. According to the CRL, “after recent completion of a pre-approval inspection of the manufacturing facility of [Fennec Pharmaceuticals’] 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, Fennec Pharmaceuticals’ share price fell more than 34%, damaging investors.
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