cosibelimab

cosibelimab: developed by 1 company · 2 FDA decisions. Updated within the last hour.

Development Pipeline (1)

CompanyPhase
Checkpoint Therapeutics, Inc. (CKPT)Phase 1

FDA Decisions

PDUFA1. INDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.(CKPT)
FDA_MeetingThe company reached alignment with the FDA on its biologics license application resubmission strategy for cosibelimab.(CKPT)

Frequently asked questions

Who is developing cosibelimab?

cosibelimab is being developed by Checkpoint Therapeutics, Inc..

What is cosibelimab's latest FDA decision?

The most recent tracked FDA decision for cosibelimab is PDUFA for 1. INDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation., dated December 28, 2024.

Get deeper analysis on cosibelimab

Full trial data, mechanism of action, competitive landscape, and AI-powered insights.

Start Free Analysis
    cosibelimab — Drug Pipeline, Trials & FDA Status | BioSniper