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Celldex Therapeutics (CLDX) FDA Events

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FDA Events for Celldex Therapeutics (CLDX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Celldex Therapeutics (CLDX). Over the past two years, Celldex Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Barzolvolimab and CDX-622. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Celldex Therapeutics' Drugs in FDA Review

Barzolvolimab - FDA Regulatory Timeline and Events

Barzolvolimab is a drug developed by Celldex Therapeutics for the following indication: For Prurigo Nodularis. 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.

CDX-622 - FDA Regulatory Timeline and Events

CDX-622 is a drug developed by Celldex Therapeutics for the following indication: For the Treatment of Inflammatory Diseases. 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.

Celldex Therapeutics FDA Events - Frequently Asked Questions

In the past two years, Celldex Therapeutics (CLDX) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Celldex Therapeutics (CLDX) has reported FDA regulatory activity for the following drugs: Barzolvolimab and CDX-622.

The most recent FDA-related event for Celldex Therapeutics occurred on June 14, 2025, involving Barzolvolimab. The update was categorized as "Data," with the company reporting: "Celldex Therapeutics, Inc. announced data demonstrating that barzolvolimab profoundly improves angioedema at 52 weeks in the Company's Phase 2 clinical trial in chronic spontaneous urticaria (CSU)."

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

  • For Prurigo Nodularis - Barzolvolimab
  • For the Treatment of Inflammatory Diseases - CDX-622

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:CLDX) was last updated on 7/11/2025 by MarketBeat.com Staff
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