NEW YORK, NY - 
(NewMediaWire) - May 13, 2024 - Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) reminds investors that a complaint has been filed on behalf of purchasers or acquirers of Checkpoint Therapeutics, Inc. (“Checkpoint” or the “Company”) (NASDAQ: CKPT) securities between March 10, 2021 and December 15, 2023 (the “Class Period”). Click Here to Join Investigation.
Deadline Reminder: If you are a member of the proposed Class, you may move the court no later than June 4, 2024 to serve as a lead plaintiff for the purported class. If you have losses, we encourage you to contact us to learn more about the lead plaintiff process.
On December 18, 2023, Checkpoint issued a press release disclosing that the U.S. Food and Drug Administration (“FDA”) had not approved the cosibelimab Biologics License Application (“BLA”), stating in relevant part that “the [FDA] has issued a complete response letter ('CRL') for the cosibelimab [BLA] for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (‘cSCC’) who are not candidates for curative surgery or radiation" and "[t]he CRL . . . cites findings that arose during a multi-sponsor inspection of Checkpoint's third-party contract manufacturing organization 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.
The complaint alleges, among other things, that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing 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 for cosibelimab; (iii) all of the foregoing reduced the likelihood that the FDA would approve the cosibelimab BLA in its present form; and (iv) as a result, the manufacturing, regulatory, and commercial prospects of cosibelimab were overstated.
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