NEW YORK, NY / ACCESSWIRE / February 18, 2022 / Pomerantz LLP announces that a class action lawsuit has been filed against Fennec Pharmaceuticals Inc. ("Fennec" or the "Company") (NASDAQ:FENC) and certain of its officers. The class action, filed in the United States District Court for the Middle District of North Carolina, and docketed under 22-cv-00115, is on behalf of a class consisting of 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 (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased or otherwise acquired Fennec securities during the Class Period, you have until April 11, 2022 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
[Click here for information about joining the class action]
Fennec is a biopharmaceutical company that develops product candidates for use in the treatment of cancer in the United States. 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").
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's 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 Company's 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, Fennec's common share price fell $4.86 per share, or 50.41%, to close at $4.78 per share on November 29, 2021.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.
SOURCE: Pomerantz LLP