Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Fennec Pharmaceuticals Inc. (“Fennec” or the “Company”) (NASDAQ: FENC) in the United States District Court for the Middle District of North Carolina on behalf of all persons and entities who purchased or otherwise acquired Fennec securities between May 28, 2021 and November 26, 2021, both dates included, (the “Class Period”). Investors have until April 11, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Click here to participate in the action.
According to the complaint, Fennec completed its submission of a 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, in February 2020. In August 2020, Fennec announced it had received a Complete Response Letter (“CRL”) from the FDA for the NDA because of deficiencies identified at the manufacturing facility of the Company's drug product manufacturer. Fennec resubmitted the NDA in May 2021.
On November 29, 2021, Fennec announced “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].” Deficiencies at the manufacturing facility of Fennec’s drug product manufacturer had again been identified, and “[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 PEDMARK™.”
On this news, Fennec’s share price fell over 50%, to close at $4.78 per share on November 29, 2021.
If you purchased or otherwise acquired Fennec shares 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 Brandon Walker or Alexandra Raymond by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
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Contacts
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Alexandra B. Raymond, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
