Fennec is a biopharmaceutical company that develops product candidates for use in the treatment of cancer in the United States. The Companys lead product candidate is PEDMARK, a formulation of sodium thiosulfate, which has completed a Phase III clinical trial for the prevention of cisplatin induced hearing loss, or ototoxicity, in children. In December 2018, Fennec initiated a rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for PEDMARK for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localized, non-metastatic, solid tumors, which was completed in February 2020 (the Initial Pedmark NDA). In August 2020, Fennec announced that it had received a Complete Response Letter (CRL) from the FDA for the Initial Pedmark NDA because of deficiencies identified at the manufacturing facility of the Companys drug product manufacturer. Then, in May 2021, the Company announced that it had resubmitted the NDA for PEDMARK with the FDA following receipt of final minutes from a Type A meeting with the FDA (the Resubmitted Pedmark NDA). The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Companys business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Fennec had not successfully remediated, and overstated its efforts to remediate, issues with the manufacturing facility of its drug product manufacturer for PEDMARK; (ii) as a result, the FDA was unlikely to approve the Resubmitted Pedmark NDA; (iii) accordingly, the regulatory and commercial prospects of the Resubmitted Pedmark NDA were overstated; and (iv) as a result, the Companys public statements were materially false and misleading at all relevant times. On November 29, 2021, during pre-market hours, Fennec issued a press release announc[ing] that it expects to receive a [CRL] after the PDUFA [Prescription Drug User Fee Act] target action date of November 27, 2021 from the [FDA] regarding its [Resubmitted Pedmark NDA]. Specifically, Fennec advised investors that [t]he FDA has indicated that, following a recent completion of a pre-approval inspection of the manufacturing facility of our drug product manufacturer, deficiencies have been identified[,] and that [o]nce the official CRL is received, the Company plans to request a Type A meeting to discuss the deficiencies and steps required for the resubmission of the NDA for PEDMARKTM. On this news, Fennecs common share price fell $4.86 per share, or 50.41%, to close at $4.78 per share on November 29, 2021.
The alleged class includes : All persons and entities other than Defendants that purchased or otherwise acquired Fennec securities between May 28, 2021 and November 26, 2021, both dates inclusive.
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