Fennec Pharmaceuticals Inc. (FENC) Receives a CRL for PEDMARK Due to Deficiencies at Manufacturing Facility
A shareholder filed a class action on behalf of purchasers of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) securities between May 28, 2021 and November 26, 2021, for violations of the Securities Exchange Act of 1934. Fennec is a biopharmaceutical company. Its lead product candidate is PEDMARK, which has completed a PHASE III clinical trial for the prevention of cisplatin induced hearing loss, or ototoxicity, in children.
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.
Next Steps: If you purchased shares of Fennec Pharmaceuticals Inc. (FENC) between May 28, 2021 and November 26, 2021, you have until April 11, 2022, to ask the court to appoint you lead plaintiff for the class. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.