A lawsuit was filed on behalf of investors in Fennec Pharmaceuticals Inc. (NASDAQ:FENC) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 02/24/2022 -- An investor, who purchased NASDAQ: FENC shares, filed a lawsuit against Fennec Pharmaceuticals Inc. over alleged violations of Federal Securities Laws.
Investors who purchased shares of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) have certain options and for certain investors are short and strict deadlines running. Deadline: April 11, 2022. NASDAQ: FENC investors should contact the Shareholders Foundation at firstname.lastname@example.org or call +1(858) 779 - 1554.
North Carolina based Fennec Pharmaceuticals Inc., a biopharmaceutical company, develops product candidates for use in the treatment of cancer in the United States.
In December 2018, Fennec Pharmaceuticals Inc 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 Pharmaceuticals Inc 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.
In May 2021, Fennec Pharmaceuticals Inc 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 Pharmaceuticals Inc. (NASDAQ: FENC) that ". . . it expects the U.S. Food and Drug Administration will not accept the company's New Drug Application for PEDMARK™." Fennec Pharmaceuticals Inc. also stated that ". . . it expects to receive a Complete Response Letter (CRL) after the PDUFA target action date of November 27, 2021 from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for PEDMARKTM (a unique formulation of sodium thiosulfate), for intravenous administration for the prevention of ototoxicity associated with cisplatin chemotherapy in pediatric patients ?1 month to 18 years of age with localized, non-metastatic, solid tumors."
Further, Fennec Pharmaceuticals Inc. reported 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."
Shares of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) declined from $10.05 per share on November 23, 2021, to as low as $3.822 per share on December 1, 2021.
The plaintiff claims that between May 28, 2021 and November 26, 2021, the Defendants made false and/or misleading statements and/or failed to disclose that Fennec Pharmaceuticals Inc. had not successfully remediated, and overstated its efforts to remediate, issues with the manufacturing facility of its drug product manufacturer for PEDMARK, that as a result, the FDA was unlikely to approve the Resubmitted Pedmark NDA, that accordingly, the regulatory and commercial prospects of the Resubmitted Pedmark NDA were overstated, and that as a result, the Company's public statements were materially false and misleading at all relevant times.
Those who purchased shares of Fennec Pharmaceuticals Inc. (NASDAQ: FENC) have certain options and should contact the Shareholders Foundation.
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