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Xencor (XNCR) FDA Events

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FDA Events for Xencor (XNCR)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Xencor (XNCR). Over the past two years, Xencor has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as XmAb and XmAb942. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Xencor's Drugs in FDA Review

XmAb - FDA Regulatory Timeline and Events

XmAb is a drug developed by Xencor for the following indication: For the treatment of patients with autoimmune 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.

XmAb942 - FDA Regulatory Timeline and Events

XmAb942 is a drug developed by Xencor for the following indication: For the treatment of cancer and other serious 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.

Xencor FDA Events - Frequently Asked Questions

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

In the past two years, Xencor (XNCR) has reported FDA regulatory activity for the following drugs: XmAb942 and XmAb.

The most recent FDA-related event for Xencor occurred on April 29, 2025, involving XmAb942. The update was categorized as "Positive Results," with the company reporting: "Xencor, Inc announced positive interim results from its first-in-human study of XmAb942, a high-potency, extended half-life, investigational anti-TL1A antibody in clinical development for patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn's disease (CD)."

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

  • For the treatment of cancer and other serious diseases - XmAb942
  • For the treatment of patients with autoimmune diseases - XmAb

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