(FENC) NEWS: Did you Suffer a Substantial Loss? Contact Johnson Fistel About Leading Fennec Pharmaceuticals Class Action Lawsuit
San Diego, California–(Newsfile Corp. – February 10, 2022) –
Shareholder rights law firm Johnson Fistel, LLP announces that a class action lawsuit has commenced on behalf of investors of Fennec Pharmaceuticals Inc. (“Fennec” or the “Company”) (NASDAQ: FENC) who purchased Fennec common stock between May 28, 2021 and November 26, 2021, both dates inclusive (the “Class Period”). To serve as lead plaintiff in this class action, you must move the Court no later than April 11, 2022.
What actions may I take at this time? If you suffered a substantial loss and are interested in learning more about being a lead plaintiff, please contact Jim Baker (jimb@johnsonfistel.com) by email or phone at 619-814-4471. If emailing, please include a phone number. Additionally, you can:
To join this action, you can go to: https://www.cognitoforms.com/JohnsonFistel/FennecPharmaceuticalsInc or [Click here to join this action]. There is no cost or obligation to you.
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.”
A lead plaintiff will act on behalf of all other class members in directing the Fennec class-action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the class-action lawsuit. An investor’s ability to share any potential future recovery of the Fennec class action lawsuit is not dependent upon serving as lead plaintiff.
About Johnson Fistel, LLP:
Johnson Fistel, LLP is a nationally recognized shareholder rights law firm with offices in California, New York and Georgia. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits. For more information about the firm and its attorneys, please visit http://www.johnsonfistel.com. Attorney advertising. Past results do not guarantee future outcomes.
Contact:
Johnson Fistel, LLP
Jim Baker, 619-814-4471
jimb@johnsonfistel.com
To join this action, you can go to: https://www.cognitoforms.com/JohnsonFistel/FennecPharmaceuticalsInc or [Click here to join this action]. There is no cost or obligation to you.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/113404