Welcome to our dedicated page for Checkpoint Therapeutics news (Ticker: CKPT), a resource for investors and traders seeking the latest updates and insights on Checkpoint Therapeutics stock.
Checkpoint Therapeutics, Inc. (NASDAQ: CKPT) is a clinical-stage biopharmaceutical company pioneering targeted immuno-oncology therapies for solid tumors. This page provides investors and healthcare professionals with comprehensive updates on CKPT's clinical developments, regulatory milestones, and strategic partnerships.
Access timely updates on key initiatives including PD-L1 inhibitor cosibelimab trials, EGFR-targeted therapies, and collaboration agreements. Our news collection covers essential developments such as clinical trial results, FDA communications, licensing deals, and financial updates - all critical for understanding CKPT's position in the competitive oncology market.
Bookmark this page for structured access to CKPT's progress in advancing non-chemotherapy treatments through innovative mechanisms. Stay informed about material events affecting the company's pipeline and market strategy without promotional bias.
Checkpoint Therapeutics has resubmitted its Biologics License Application (BLA) to the FDA for cosibelimab, an anti-PD-L1 antibody aimed at treating metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). The resubmission follows alignment with the FDA to address issues cited in a December CRL, which highlighted deficiencies found during a CMO inspection but did not raise concerns about clinical data, safety, or labeling. The BLA is supported by positive results from pivotal studies in cSCC, showing high objective and complete response rates, with longer-term data revealing deepening responses over time. Cosibelimab is a high-affinity, fully-human IgG1 subtype antibody designed to block PD-L1 interactions and potentially enhance anti-tumor immune responses.
Checkpoint Therapeutics has announced alignment with the FDA on its resubmission strategy for cosibelimab's biologics license application (BLA).
The BLA resubmission aims to gain U.S. marketing approval for cosibelimab as a treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients unsuitable for curative surgery or radiation.
The alignment follows a complete response letter (CRL) from the FDA in December 2023, which identified issues with the contract manufacturing organization but did not raise concerns about clinical data, safety, or labeling.
Checkpoint Therapeutics, Inc. will participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference where James Oliviero, President and CEO, will have a fireside chat. The event will take place on May 20, 2024, at 12:30 p.m. ET at NASDAQ. Checkpoint will also have one-on-one meetings during the conference. A webcast of the fireside chat will be available on the News & Events page of Checkpoint's website for 30 days post-event.
Checkpoint Therapeutics, Inc. reported financial results for Q1 2024, revealing increased cash reserves, reduced R&D expenses, and an appointment to the Board of Directors. The company aims to address FDA feedback for potential BLA resubmission mid-year.
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