NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Checkpoint Therapeutics, Inc. (“Checkpoint” or the “Company”) (NASDAQ: CKPT) in the United States District Court for the Southern District of New York on behalf of all persons and entities who purchased or otherwise acquired Checkpoint securities between March 10, 2021 and December 15, 2023, both dates inclusive (the “Class Period”). Investors have until June 4, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Checkpoint is a clinical-stage immunotherapy and targeted oncology company that focuses on the acquisition, development, and commercialization of novel treatments for patients with solid tumor cancers in the U.S. and internationally. The Company relies on third-party contract manufacturers to, inter alia, conduct its preclinical and clinical studies and trials, as well as to complete commercial and pre-commercial manufacturing.
Checkpoint's lead antibody product candidate is cosibelimab for the treatment of selected recurrent or metastatic cancers. In January 2023, Checkpoint submitted a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for the approval of cosibelimab as a treatment for patients with metastatic cutaneous squamous cell carcinoma ("cSCC") or locally advanced cSCC who are not candidates for curative surgery or radiation (the "cosibelimab BLA").
The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Checkpoint had overstated its oversight of, and/or its establishment of adequate manufacturing standards and controls over, its third-party contract manufacturers; (ii) accordingly, there were one or more issues with the Company's third-party contract manufacturing organization ("CMO") for cosibelimab; (iii) all the foregoing reduced the likelihood that the FDA would approve the cosibelimab BLA in its present form; (iv) as a result, the manufacturing, regulatory, and commercial prospects of cosibelimab were overstated; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times.
On December 18, 2023, Checkpoint issued a press release disclosing that the FDA had not approved the cosibelimab BLA as a treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation. In particular, the Company announced "that the [FDA] has issued a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally advanced [cSCC] who are not candidates for curative surgery or radiation." The Company stated that "[t]he CRL . . . cites findings that arose during a multi-sponsor inspection of Checkpoint's third-party [CMO] as approvability issues to address in a resubmission."
On this news, Checkpoint's stock price fell $1.49 per share, or 44.88%, to close at $1.83 per share on December 18, 2023.
If you purchased or otherwise acquired Checkpoint shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Marion Passmore by email at investigations@bespc.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, California, and South Carolina. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
Contact Information:
Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Marion Passmore, Esq.
(212) 355-4648
investigations@bespc.com
www.bespc.com
