If You Invested in Checkpoint Therapeutics, Inc. (CKPT)

Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) is a commercial-stage immunotherapy and targeted oncology company in the pharmaceutical preparation manufacturing industry. The company focuses on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint was founded by Fortress Biotech, Inc. and is headquartered in Waltham, Massachusetts.

According to company disclosures, Checkpoint has received U.S. Food and Drug Administration (FDA) approval for UNLOXCYT™ (cosibelimab-ipdl). UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. The company describes UNLOXCYT as a human immunoglobulin G1 monoclonal antibody that binds programmed death ligand-1 (PD-L1) and blocks its interaction with PD-1 and B7.1 receptors, releasing the inhibitory effects of PD-L1 on the anti-tumor immune response. UNLOXCYT has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC), based on information provided in Checkpoint’s public communications.

In addition to its approved product, Checkpoint is evaluating its lead investigational small-molecule, targeted anti-cancer agent olafertinib (formerly CK-101). Olafertinib is described by the company as a third-generation epidermal growth factor receptor (EGFR) inhibitor being studied as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. These programs reflect Checkpoint’s focus on immuno-oncology and targeted therapies for solid tumors.

Checkpoint has also highlighted cosibelimab, the antibody component of UNLOXCYT, as an anti-PD-L1 therapy with a dual mechanism of action. Company materials state that cosibelimab directly binds PD-L1 to block its interaction with PD-1 and B7.1 and has a functional Fc domain capable of inducing ADCC. Before FDA approval of UNLOXCYT, Checkpoint pursued a Biologics License Application (BLA) for cosibelimab in advanced cSCC and reported pivotal trial data in locally advanced and metastatic cSCC, including longer-term results presented at the European Society for Medical Oncology (ESMO) Congress.

Checkpoint’s public statements describe the company as focused on patients with solid tumor cancers, including those with advanced skin cancers such as cSCC and those with EGFR mutation-positive non-small cell lung cancer. Its activities include clinical development, regulatory interactions with the FDA, and preparations for commercial launch and availability of UNLOXCYT in the United States following approval. The company has also announced collaborations, for example with GC Cell, to explore the combined therapeutic potential of cosibelimab with Immuncell-LC, an autologous Cytokine Induced Killer T cell therapy, in preclinical settings.

In March 2025, Checkpoint announced that it entered into an Agreement and Plan of Merger with Sun Pharmaceutical Industries, Inc. and a wholly owned subsidiary of Sun Pharma. Under the terms described in public releases, Checkpoint would continue as the surviving corporation and become a wholly owned subsidiary of Sun Pharma upon completion of the merger. The transaction is subject to customary closing conditions, including required regulatory approvals and stockholder approval, and is expected by the parties to be completed in the second quarter of 2025. As of the latest available news, the merger had not yet been completed and a special meeting of stockholders to vote on the merger was scheduled.

Checkpoint’s communications emphasize its role as a commercial-stage company following FDA approval of UNLOXCYT, while continuing to advance its pipeline candidate olafertinib. The company’s focus on immunotherapy and targeted oncology positions it within the broader field of cancer therapeutics aimed at modulating the immune system and targeting specific molecular drivers of disease.

Business focus and therapeutic areas

Based on its public descriptions, Checkpoint concentrates on:

• Immunotherapy for solid tumors: Development and commercialization of PD-L1–targeting antibodies for advanced cutaneous squamous cell carcinoma and other selected recurrent or metastatic cancers.
• Targeted oncology: Investigation of EGFR inhibitors such as olafertinib for EGFR mutation-positive non-small cell lung cancer.
• Regulatory-driven development: Advancing candidates through clinical trials, BLA submissions, and interactions with the FDA, particularly around cosibelimab/UNLOXCYT.

Regulatory and clinical context

Checkpoint’s public filings and press releases detail its regulatory pathway for UNLOXCYT, including BLA submission, a complete response letter related to a third-party contract manufacturing organization, resubmission of the BLA, and eventual FDA approval for the cSCC indication. The company has also reported on pivotal clinical trial outcomes for cosibelimab in cSCC, including objective response rates and durability of response as assessed by an independent central review committee.

Corporate background

Checkpoint states that it was founded by Fortress Biotech, Inc. and that Fortress remains a significant stockholder. The company is listed on Nasdaq under the symbol CKPT and operates in the manufacturing sector, specifically pharmaceutical preparation manufacturing, with a focus on oncology biologics and small molecules.