Pomerantz Appointed Lead Counsel in Fennec Pharmaceuticals Securities Litigation

On May 9, 2022, U.S. District Judge Catherine C. Eagles of the Middle District of North Carolina appointed Pomerantz LLP as Lead Counsel on behalf of Jeffrey D. Fisher, the Lead Plaintiff, and the class, in Fisher v. Fennec Pharmaceuticals, Inc., 22-cv-115 (M.D.N.C.). This securities action alleges that Fennec Pharmaceuticals, Inc. ("Fennec" or the "Company") misled the market regarding its remediation of manufacturing issues with Pedmark, its lead product candidate, and overstated the regulatory and commercial prospects for the drug.

Fennec is a biopharmaceutical company that develops product candidates for use in the treatment of pediatric cancer in the U.S., including Pedmark – a treatment for the prevention of cisplatin induced hearing loss, or ototoxicity, in children.

Allegations against Fennec include that: (i) Fennec had overstated its overall unsuccessful efforts to remediate manufacturing issues with Pedmark; (ii) as a result, the New Drug Application (“NDA”) for Pedmark that the Company had resubmitted to the U.S. Food and Drug Administration (“FDA”) was unlikely to be approved; and (iii) accordingly, the regulatory and commercial prospects for Pedmark were overstated.

In December 2018, Fennec initiated a rolling NDA with the FDA for Pedmark. Then, in August 2020, the Company announced that it had received a Complete Response Letter (“CRL”) from the FDA for the Pedmark NDA because of deficiencies identified at the manufacturing facility of the Company’s drug product manufacturer.

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, Fennec announced that it expected 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.”

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.