Overview

A class action lawsuit has been filed against Checkpoint Therapeutics, Inc. (“Checkpoint” or the “Company”) (NASDAQ: CKPT) and certain of the Company’s current and former senior executive officers alleging violations of the Securities Exchange Act of 1934.  The Checkpoint lawsuit is brought 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”), and investors have until June 4, 2024 to seek appointment as lead plaintiff of the Checkpoint class action lawsuit.

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 United States and internationally.  The Company relies on third-party contract manufacturers to, inter alia, conduct its pre-clinical 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 lawsuit 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.  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 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 the 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.

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If you purchased or otherwise acquired Checkpoint securities between March 10, 2021 and December 15, 2023, both dates inclusive, and suffered substantial losses, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as a lead plaintiff in the Checkpoint lawsuit is June 4, 2024.