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Checkpoint Therapeutics(CKPT) - 2024 Q2 - Quarterly Results
2024-08-12 12:45
Exhibit 99.1 Checkpoint Therapeutics Reports Second Quarter 2024 Financial Results and Recent Corporate Updates Waltham, MA – August 12, 2024 – Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We've made significant recent progress as we seek approval ...
Checkpoint Therapeutics Reports Second Quarter 2024 Financial Results and Recent Corporate Updates
GlobeNewswire News Room· 2024-08-12 12:30
WALTHAM, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We've made significant recent progress as we seek approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced ...
Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma
Newsfilter· 2024-07-25 11:30
James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We are pleased that the FDA has accepted our BLA resubmission as a complete response after we aligned on our BLA resubmission strategy. We look forward to working closely with the FDA to finalize the review and to the potential opportunity to deliver cosibelimab's unique dual mechanism of action to patients suffering from cSCC." In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose d ...
Checkpoint Therapeutics Announces FDA Acceptance of BLA Resubmission of Cosibelimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma
GlobeNewswire News Room· 2024-07-25 11:30
James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We are pleased that the FDA has accepted our BLA resubmission as a complete response after we aligned on our BLA resubmission strategy. We look forward to working closely with the FDA to finalize the review and to the potential opportunity to deliver cosibelimab's unique dual mechanism of action to patients suffering from cSCC." In December 2023, the FDA issued a CRL for the cosibelimab BLA, which only cited findings that arose d ...
GC Cell and Checkpoint Therapeutics Advance Collaborative Cancer Research
Newsfilter· 2024-07-15 12:00
Collaboration explores the potential synergistic effects of Checkpoint's anti-PD-L1, cosibelimab, in combination with the autologous T cell therapy, Immuncell-LC This collaboration will initially focus on conducting in vitro combination studies to evaluate the synergistic effects of these two therapies on cancer cell destruction. Positive preliminary data from these studies could potentially pave the way for future in vivo research and clinical studies. James Park, CEO of GC Cell, highlighted the agreement' ...
GC Cell and Checkpoint Therapeutics Advance Collaborative Cancer Research
GlobeNewswire News Room· 2024-07-15 12:00
YONGIN, South Korea and WALTHAM, Mass., July 15, 2024 (GLOBE NEWSWIRE) -- GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics ("Checkpoint") (Nasdaq: CKPT) have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody with dual mechanism of action, with GC Cell's Immuncell-LC, an innovative autologous Cytokine Induced Killer ("CIK") T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells. The anticipated synergy between c ...
Checkpoint Therapeutics Announces $12 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Newsfilter· 2024-07-02 12:00
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The shares of common stock (or common stock equivalents) described above (but not the unregistered warrants issued in the concurrent private placement or the shares of common stock underlying such unregistered warrants) are being offered by Checkpoint pursuant to a shelf registration statement on Form S-3 (File No. 333- 270843) that was previously filed with the Securities and Exchange Commission ("SEC") on March 24, 2023, an ...
Checkpoint Therapeutics Announces Biologics License Application Resubmission for Cosibelimab
Newsfilter· 2024-07-02 11:00
WALTHAM, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has completed the resubmission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") wh ...
Checkpoint Therapeutics Announces Biologics License Application Resubmission for Cosibelimab
GlobeNewswire News Room· 2024-07-02 11:00
Additionally, in July 2023, Checkpoint announced longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cSCC demonstrating a deepening of response over time, resulting in higher complete response rates than previously reported (55% objective response rate; 26% complete response rate in locally advanced cSCC and 50% objective response rate; 13% complete response rate in metastatic cSCC). Checkpoint Therapeutics, Inc. is a clinical-stage immunotherapy and targeted oncolog ...
Checkpoint Therapeutics Announces Alignment with FDA Enabling Upcoming Cosibelimab BLA Resubmission
Newsfilter· 2024-06-24 11:30
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, ...