FDA Approves Cosibelimab-ipdl for Treatment of Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma / Andrea Tazbirkova, Andrew Michael Mant,

Oncology Brothers: 6 new drugs in Skin Cancer, Thyroid Cancer, Sarcoma and Glioma by U.S. FDA / AfamiCel, cancer, Cosibelimab, glioma, Lifileucel, OncoDaily,

Cosibelimab (UNLOXCYT; cosibelimab-ipdl) is an anti-PD-L1 antibody developed by Checkpoint Therapeutics for the treatment of advanced cancers, including metastatic or locally advanced cutaneous squamo...

Will add UNLOXCYT™ (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell...

The FDA has approved Unloxcyt (cosibelimab-ipdl) to treat advanced cutaneous squamous cell carcinoma.

Cosibelimab-ipdl, a high-affinity, programmed death-ligand 1–blocking antibody, is approved by the US Food and Drug Administration for treatment of ad…

More than 71% of patients treated with Unloxcyt achieved disease control

The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

New Delhi: Sun Pharmaceutical Industries Limited has announced that UNLOXCYT (cosibelimab-ipdl) is now available in the United States for prescription by healthcare professionals for the treatment...

The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

The FDA has updated the label for UNLOXCYT™, an innovative treatment for advanced squamous cell carcinoma, showcasing improved outcomes based on long-term data.

Checkpoint Therapeutics (NASDAQ: CKPT) announced its Q1 2025 financial results and significant corporate updates. The company achieved a major milestone with the FDA approval of UNLOXCYT™ (cosibelimab-ipdl) in December 2024, becoming the first and only PD-L1 blocking antibody approved for treating advanced cutaneous squamous cell carcinoma. In March 2025, Checkpoint entered into a merger agreement with Sun Pharmaceutical Industries, valued at up to $416 million, with the special stockholder meeting scheduled for May 28, 2025.Financial highlights for Q1 2025 include: cash position increased to $33.0 million from $6.6 million in Q4 2024; R&D expenses decreased to $3.8 million from $8.5 million year-over-year; G&A expenses increased to $7.4 million from $2.5 million; and net loss was $11.2 million ($0.19 per share) compared to $10.9 million ($0.33 per share) in Q1 2024.

Sun Pharma has announced the acquisition of Checkpoint Therapeutics (CKPT) in a deal valued at up to $355 million, offering $4.10 per share in upfront cash payment plus a contingent value right of up to $0.70 per share. The acquisition centers on UNLOXCYT™ (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC).The deal represents a 66% premium to Checkpoint's closing price on March 7, 2025. The transaction, expected to close in Q2 2025, requires stockholder and regulatory approvals. Checkpoint reported minimal revenue of $0.04 million and a net loss of $27.3 million for the nine months ending September 2024, with R&D expenses of $19.3 million.Fortress Biotech, Checkpoint's controlling stockholder, will receive royalty payments based on future cosibelimab sales and has agreed to vote in favor of the transaction.

Breakthrough FDA approval for UNLOXCYT, first PD-L1 blocking antibody treating advanced skin cancer. Novel therapy targets billion-dollar market with unique dual mechanism.

Sunandana Chandra, MD, discusses the current systemic treatment landscape for patients with unresectable, locally advanced, or metastatic cutaneous squamous cell carcinoma.

The prescribing information for cosibelimab in advanced cutaneous squamous cell carcinoma was updated to include long-term data from the CK-301-101 trial.