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Checkpoint Therapeutics (CKPT) FDA Events

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FDA Events for Checkpoint Therapeutics (CKPT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Checkpoint Therapeutics (CKPT). Over the past two years, Checkpoint Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Cosibelimab and Cosibelimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Checkpoint Therapeutics' Drugs in FDA Review

Cosibelimab (cSCC) - FDA Regulatory Timeline and Events

Cosibelimab (cSCC) is a drug developed by Checkpoint Therapeutics for the following indication: Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Cosibelimab (formerly CK-301) - FDA Regulatory Timeline and Events

Cosibelimab (formerly CK-301) is a drug developed by Checkpoint Therapeutics for the following indication: Metastatic cutaneous squamous cell carcinoma (mCSCC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Checkpoint Therapeutics FDA Events - Frequently Asked Questions

Yes, Checkpoint Therapeutics (CKPT) has received FDA approval for Cosibelimab (cSCC). This page tracks recent and historical FDA regulatory events related to Checkpoint Therapeutics' drug portfolio.

In the past two years, Checkpoint Therapeutics (CKPT) has reported FDA regulatory activity for the following drugs: Cosibelimab (cSCC) and Cosibelimab (formerly CK-301).

The most recent FDA-related event for Checkpoint Therapeutics occurred on December 13, 2024, involving Cosibelimab (cSCC). The update was categorized as "FDA Approval," with the company reporting: "Checkpoint Therapeutics announced that the U.S. Food and Drug Administration ("FDA") has approved UNLOXCYT™ (cosibelimab-ipdl) 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."

Current therapies from Checkpoint Therapeutics in review with the FDA target conditions such as:

  • Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC) - Cosibelimab (cSCC)
  • Metastatic cutaneous squamous cell carcinoma (mCSCC) - Cosibelimab (formerly CK-301)

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:CKPT) was last updated on 7/10/2025 by MarketBeat.com Staff
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