A securities class action has been filed in the USDC — S.D.N.Y. against Checkpoint Therapeutics, Inc. (CKPT) (“Checkpoint” or the “Company”), on behalf of all persons and entities that purchased or otherwise acquired Checkpoint securities between March 10, 2021 and December 15, 2023, both dates inclusive (the “Class Period”).
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:
(1) Checkpoint had overstated its oversight of, and/or its establishment of adequate manufacturing standards and controls over, its third-party contract manufacturers;
(2) accordingly, there were one or more issues with the Company’s third-party contract manufacturing organization (“CMO”) for cosibelimab;
(3) all the foregoing reduced the likelihood that the FDA would approve the cosibelimab BLA in its present form;
(4) as a result, the manufacturing, regulatory, and commercial prospects of cosibelimab were overstated; and
(5) as a result, the Company’s public statements were materially false and misleading at all relevant times, thereby harming investors.
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