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CytomX Therapeutics (CTMX) FDA Events

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FDA Events for CytomX Therapeutics (CTMX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by CytomX Therapeutics (CTMX). Over the past two years, CytomX Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CX-2051 and CX-801. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

CytomX Therapeutics' Drugs in FDA Review

CX-2051 - FDA Regulatory Timeline and Events

CX-2051 is a drug developed by CytomX Therapeutics for the following indication: A Probody® Antibody Drug Conjugate (ADC). 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.

CX-801 - FDA Regulatory Timeline and Events

CX-801 is a drug developed by CytomX Therapeutics for the following indication: In patients with solid tumors. 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.

CytomX Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, CytomX Therapeutics (CTMX) has reported FDA regulatory activity for the following drugs: CX-801 and CX-2051.

The most recent FDA-related event for CytomX Therapeutics occurred on May 19, 2025, involving CX-801. The update was categorized as "Dose Update," with the company reporting: "CytomX Therapeutics, Inc. announced that the first patient has been dosed with CX-801 in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in the ongoing Phase 1 dose escalation study (NCT06462794) evaluating safety and initial clinical activity in patients with metastatic melanoma."

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

  • In patients with solid tumors - CX-801
  • A Probody® Antibody Drug Conjugate (ADC) - CX-2051

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:CTMX) was last updated on 7/10/2025 by MarketBeat.com Staff
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