The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Middle District of North Carolina on behalf of those who acquired Fennec Pharmaceuticals Inc. (“Fennec” or the “Company”) (NASDAQ: FENC) securities from May 28, 2021 to November 26, 2021 inclusive (the “Class Period”). Investors have until April 11, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Fennec is a biopharmaceutical company that develops product candidates for use in the treatment of cancer. The Company’s 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 Company’s 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”).

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 PEDMARK^TM.” On this news, Fennec’s share price declined by $4.86 per share, or approximately 50.41%, from $9.64 per share to close at $4.78 per share on November 29, 2021.

The lawsuit alleges throughout the Class Period, Defendants failed to disclose that Fennec had not successfully remediated, and overstated its efforts to remediate, issues with the manufacturing facility of its drug product manufacturer for PEDMARK; and accordingly, the regulatory and commercial prospects of the Resubmitted Pedmark NDA were overstated.

If you purchased or otherwise acquired Fennec securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.

Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website: http://www.kmllp.com.

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