Core Viewpoint - Checkpoint Therapeutics has resubmitted its Biologics License Application (BLA) for cosibelimab to the FDA, aiming to address previous approvability deficiencies and seeking approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation [5][4]. Company Overview - Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on developing novel treatments for solid tumor cancers [2]. - The company is evaluating cosibelimab, an anti-PD-L1 antibody, and olafertinib, a third-generation EGFR inhibitor, for various cancer treatments [2]. Product Details - Cosibelimab is a fully-human monoclonal antibody that inhibits the interaction between PD-L1 and its receptors, potentially enhancing anti-tumor immune responses [6]. - The drug has shown promising results in pivotal studies, with a 55% objective response rate and a 26% complete response rate in locally advanced cSCC, and a 50% objective response rate and a 13% complete response rate in metastatic cSCC [1]. Regulatory Progress - The BLA resubmission follows alignment with the FDA on addressing issues raised in a previous complete response letter (CRL), which did not express concerns about the clinical data package [4]. - The resubmission is supported by recent study results published in October 2023, indicating the efficacy and safety of cosibelimab in treating selected recurrent or metastatic cancers [9].

In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose during a multi-sponsor inspection of Checkpoint's third-party contract manufacturing organization ("CMO") as approvability issues to address in a BLA resubmission. The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab. Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, ...

James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We're pleased to have reached alignment with the FDA on our BLA resubmission strategy to potentially address all approvability deficiencies outlined in the complete response letter ("CRL") received last December. We're eager to resubmit our BLA and to potentially bring a new and potentially differentiated immunotherapy treatment option to patients with advanced cSCC." This press release contains "forward-looking statements" withi ...

NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Checkpoint Therapeutics, Inc. (NASDAQ: CKPT) on behalf of long-term stockholders following a class action complaint that was filed against Checkpoint on April 5, 2024 with a Class Period from March 10, 2021 to December 15, 2023. Our investigation concerns whether the board of directors of Checkpoint have breached their fiduciary duties to the ...

NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Checkpoint Therapeutics, Inc. (NASDAQ: CKPT) between March 10, 2021 and December 15, 2023, both dates inclusive (the "Class Period"), of the important June 4, 2024 lead plaintiff deadline. SO WHAT: If you purchased Checkpoint securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee ar ...

NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Checkpoint Therapeutics, Inc. ("Checkpoint" or the "Company") (NASDAQ:CKPT) and reminds investors of the June 4, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $1 ...

NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Checkpoint Therapeutics, Inc. ("Checkpoint" or the "Company") (NASDAQ: CKPT) and reminds investors of the June 4, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $ ...

NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Checkpoint Therapeutics, Inc. ("Checkpoint" or "the Company") (NASDAQ: CKPT) and certain of its officers. Class Definition: This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acq ...

LOS ANGELES, May 24, 2024 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of a class action lawsuit against Checkpoint Therapeutics, Inc. ("Checkpoint" or "the Company") (NASDAQ: CKPT) for for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Investors who purchased the Company's securities between March 10, 2021 and December 15, 2023, inclusive (th ...

LOS ANGELES, May 16, 2024 /PRNewswire/ -- Glancy Prongay & Murray LLP ("GPM") announces that investors with substantial losses have opportunity to lead the securities fraud class action lawsuit against Checkpoint Therapeutics, Inc. ("Checkpoint" or the "Company") (NASDAQ: CKPT). Class Period: March 10, 2021 – December 15, 2023 Lead Plaintiff Deadline: June 4, 2024 If you wish to serve as lead plaintiff of the Checkpoint lawsuit, you can submit your contact information at www.glancylaw.com/cases/Checkpoint-T ...