PR Newswire
NEW YORK
,
Feb. 11, 2022
/PRNewswire/ — Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of Fennec Pharmaceuticals Inc. (“Fennec” or the “Company”) (NASDAQ: FENC) between
May 28, 2021
and
November 26, 2021
, inclusive (the “Class Period”). The lawsuit was filed in
the United States
District Court for the Middle District of
North Carolina
and alleges violations of the Securities Exchange Act of 1934.
If you
purchased Fennec securities, and/or would like to discuss your legal rights and options
please visit
Fennec Pharmaceuticals Inc. Shareholder Class Action Lawsuit
or contact
Joe Seidman
toll free at
(877) 779-1414
or
[email protected]
.
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 PEDMARK
TM
.”
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
.
If you wish to serve as lead plaintiff, you must move the Court no later than
April 11, 2022
. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
If you
purchased FENC securities, and/or would like to discuss your legal rights and options
please visit
or contact
Joe Seidman
toll free at
(877) 779-1414
or
[email protected]
.
Since 1993, Bernstein Liebhard LLP has recovered over
$3.5 billion
for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal’s “Plaintiffs’ Hot List” thirteen times and listed in The Legal 500 for ten consecutive years.
ATTORNEY ADVERTISING. © 2022 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street,
New York, New York
10016, (212) 779-1414. The lawyer responsible for this advertisement in the
State of Connecticut
is Michael S. Bigin. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Contact Information:
Joe Seidman
Bernstein Liebhard LLP
(877) 779-1414
[email protected]
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SOURCE Bernstein Liebhard LLP
