NEW YORK, 09 Feb. 12, 2022 (GLOBE NEWSWIRE) — Pomerantz LLP announces that a class action lawsuit has been filed against Fennec Pharmaceuticals Inc. (“Fennec” or the “Company”) (FENC) and certain of its officers. The class action, filed in the United States District Court for the Intermediate District of North Carolina and registered as 22-cv-00115, is on behalf of a class consisting of all persons and entities other than defendants who 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 the Defendants’ violations of federal laws securities and to seek 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 senior executives.
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 making inquiries by e-mail are encouraged to include their mailing address, phone number and number of shares purchased.
[Click here for information about joining the class action]
Fennec is a biopharmaceutical company developing product candidates for 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 filed a New Drug Application (“NDA”) with the United States Food and Drug Administration (“FDA”) for PEDMARK for the prevention of cisplatin chemotherapy-induced ototoxicity in patients aged 1 month to
In August 2020, Fennec announced that it had received a Complete Response Letter (“CRL”) from the FDA for Pedmark’s initial NDA due to identified deficiencies in the company’s pharmaceutical manufacturer’s manufacturing facility. .
Then, in May 2021, the company announced that it had resubmitted the NDA for PEDMARK to the FDA following receipt of the final minutes of a Type A meeting with the FDA (the “Resubmitted Pedmark NDA “).
The Complaint alleges that, throughout the Class Period, the Defendants made materially false and misleading statements regarding the company’s business, operations and prospects. Specifically, the defendants made false and/or misleading statements and/or failed to disclose that: (i) Fennec failed to resolve and overstated its efforts to resolve the issues with the manufacturing plant of its pharmaceutical manufacturer for PEDMARK; (ii) as a result, the FDA was unlikely to approve the NDA Resubmitted Pedmark; (iii) as a result, the regulatory and commercial prospects of the NDA Resubmitted Pedmark have been overstated; and (iv) as a result, the Company’s public statements were materially false and misleading at all material times.
On November 29, 2021, during pre-marketing hours, Fennec published a press release “announces[ing] that he expects to receive a [CRL] after the PDUFA [Prescription Drug User Fee Act] target date for action of November 27, 2021 from [FDA] concerning his [Resubmitted Pedmark NDA].” Specifically, Fennec advised investors that “[t]The FDA advised that following the recent completion of a pre-approval inspection of our pharmaceutical manufacturer’s manufacturing facility, deficiencies were identified[,]” and that “[o]Once the official CRL is received, the Company plans to request an A-type meeting to discuss the gaps and steps required for the re-submission of the NDA for PEDMARKMT.”
On this news, Fennec’s common stock 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 recognized as one of the leading law firms in the areas of corporate litigation, securities and antitrust. 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 the tradition he established, fighting for the rights of victims of securities fraud, breaches of fiduciary duty and corporate misconduct. The firm recovered numerous multimillion-dollar damages on behalf of class members. See www.pomlaw.com.
Robert S. Willoughby
888-476-6529 ext. 7980