Investigation Overview
An investigation on behalf of investors of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) shares over potential securities laws violations by Fennec Pharmaceuticals Inc. and certain of its directors and officers in connection with certain financial statements was announced.
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) concerning whether a series of statements by Fennec Pharmaceuticals Inc. regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
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 [Fennecs] 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.