Lawsuit Overview
February 1, 2021 - An amended consolidated complaint was filed.
September 3, 2020 - An investor in shares of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) filed a lawsuit in the U.S. District Court for the Middle District of North Carolina over alleged violations of Federal Securities Laws by Fennec Pharmaceuticals Inc. in connection with certain allegedly false and misleading statements made between February 11, 2020 and August 10, 2020.
Research Triangle, Park, NC based Fennec Pharmaceuticals Inc., a biopharmaceutical company, develops product candidates for use in the treatment of cancer in the United States.
On August 11, 2020, Fennec Pharmaceuticals Inc. 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, a formulation of sodium thiosulfate for intravenous administration for the ototoxicity associated with cisplatin chemotherapy. 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. Shares of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) declined from $10.67 per share on August 10, 2020, to as low as $5.12 per share on August 25, 2020.
According to the complaint the plaintiff alleges on behalf of purchasers of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) common shares between February 11, 2020 and August 10, 2020, that the defendants violated Federal Securities Laws.
More specifically, the plaintiff claims that between February 11, 2020 and August 10, 2020, the defendants failed to disclose to investors that the manufacturing facilities for PEDMARK, the Company’s sole product candidate, did not comply with current good manufacturing practices, that, as a result, regulatory approval for PEDMARK was reasonably likely to be delayed, and 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.