NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed 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 Therapeutics, Inc. (“Checkpoint” or the “Company”) (NYSE: CKPT) securities between March 10, 2021 and December 15, 2023, inclusive (the “Class Period”). The Complaint in the lawsuit seeks to recover damages for the Company’s investors under the federal securities laws.
The Complaint alleges that Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, the Complaint alleges that 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.
The Complaint further alleges that 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. The Complaint also alleges that 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 Complaint further alleges that 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.”
The Complaint alleges that 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.
Investors who purchased or otherwise acquired shares of Checkpoint Therapeutics, Inc. should contact the Firm prior to the June 4, 2024 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.
Please visit our website at http://www.gme-law.com for more information about the firm.
