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Checkpoint Therapeutics, Inc. - CKPT STOCK NEWS

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., listed under the ticker CKPT, is a pioneering immuno-oncology biopharmaceutical company dedicated to the acquisition, development, and commercialization of novel treatments for patients with solid tumor cancers. Founded in 2014 and headquartered in New York, New York, the company operates as a subsidiary of Fortress Biotech, Inc.

Checkpoint Therapeutics focuses on developing non-chemotherapy, immune-enhanced combination treatments. One of its leading product candidates is CK-101, currently in phase I clinical trials, aimed at treating epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer. Another significant candidate is Cosibelimab, a programmed death ligand-1 (PD-L1) inhibitor in phase I trials for selected recurrent or metastatic cancers.

In addition to these, Checkpoint Therapeutics is working on CK-103, a small molecule inhibitor targeting BET bromodomains, and CK-302, a human agonistic antibody designed for oncology indications. The company has also developed a strong portfolio of antibodies focusing on PD-L1, GITR, and CAIX targets.

Checkpoint Therapeutics collaborates with TG Therapeutics, Inc. to develop and commercialize specific assets in hematological malignancies. This partnership underscores the company's commitment to advancing cancer therapies through strategic alliances.

Checkpoint Therapeutics' robust pipeline, innovative approaches to cancer treatment, and strategic collaborations make it a significant player in the biopharmaceutical industry. Investors and stakeholders can look forward to the company's continuous advancements and contributions to oncology.

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Checkpoint Therapeutics (Nasdaq: CKPT) announced a $12 million registered direct offering with a healthcare-focused institutional investor. The deal includes 5,853,659 shares of common stock at $2.05 per share. Concurrently, Checkpoint will issue unregistered warrants for the same number of shares, exercisable at $2.05 per share post-shareholder approval and expiring in five years. H.C. Wainwright & Co. is the exclusive placement agent. The offering is expected to close around July 3, 2024. Gross proceeds will support working capital and general corporate purposes. Shares are offered under a previously filed and effective shelf registration statement with the SEC.

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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.

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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.

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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.

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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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Checkpoint Therapeutics, Inc. announces financial results for full-year 2023 and corporate updates. The company plans to resubmit a Biologics License Application for cosibelimab by mid-year for potential approval before 2024 end. Checkpoint remains confident in the clinical data and safety package.
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Checkpoint Therapeutics, Inc. appoints Dr. Amit Sharma as an independent director to its Board. Dr. Sharma brings extensive experience in clinical development and leadership roles from his tenure at Alexion and Bayer Pharmaceuticals.
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Checkpoint Therapeutics, Inc. has entered into an agreement for the issuance and sale of over 7.7 million shares of its common stock in a registered direct offering priced at-the-market. The company will also issue unregistered warrants to purchase additional shares. The offering is expected to raise significant capital for the company's clinical-stage immunotherapy and targeted oncology programs.
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Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) announced that James Oliviero, President and CEO, will participate in a fireside chat at the B. Riley Securities 4th Annual Oncology Conference on January 18, 2024, at 4:00 p.m. EST.
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FDA Raises No Concerns for XYZ Pharmaceuticals (Ticker: XYZ)
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FAQ

What does Checkpoint Therapeutics, Inc. specialize in?

Checkpoint Therapeutics, Inc. specializes in the acquisition, development, and commercialization of novel immuno-oncology treatments for patients with solid tumor cancers.

What are the key products in Checkpoint Therapeutics' pipeline?

Checkpoint Therapeutics' key products include CK-101 for non-small cell lung cancer, Cosibelimab for recurrent or metastatic cancers, CK-103, a BET bromodomain inhibitor, and CK-302, a human agonistic antibody.

Where is Checkpoint Therapeutics headquartered?

Checkpoint Therapeutics is headquartered in New York, New York, USA.

When was Checkpoint Therapeutics founded?

Checkpoint Therapeutics was founded in 2014.

What strategic partnerships does Checkpoint Therapeutics have?

Checkpoint Therapeutics has a collaboration agreement with TG Therapeutics, Inc. to develop and commercialize assets in the field of hematological malignancies.

What is Cosibelimab?

Cosibelimab is a programmed death ligand-1 (PD-L1) inhibitor in phase I clinical trials for selected recurrent or metastatic cancers.

What stage is CK-101 in?

CK-101 is currently in phase I clinical trials for the treatment of EGFR mutation-positive non-small cell lung cancer.

Who is the parent company of Checkpoint Therapeutics?

Checkpoint Therapeutics is a subsidiary of Fortress Biotech, Inc.

What types of cancers is Checkpoint Therapeutics focusing on?

Checkpoint Therapeutics focuses on treatments for solid tumor cancers.

Does Checkpoint Therapeutics have any small molecule inhibitors in development?

Yes, Checkpoint Therapeutics is developing CK-103, a small molecule inhibitor targeting BET bromodomains.

Checkpoint Therapeutics, Inc.

Nasdaq:CKPT

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CKPT Stock Data

89.49M
37.38M
18.83%
16.12%
10.36%
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