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argenex (ARGX) FDA Events

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FDA Events for argenex (ARGX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by argenex (ARGX). Over the past two years, argenex has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ALKIVIA, ARGX-119, efgartigimod, VYVGART, and VYVGART. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

argenex's Drugs in FDA Review

ALKIVIA - FDA Regulatory Timeline and Events

ALKIVIA is a drug developed by argenex for the following indication: In Idiopathic Inflammatory Myopathies. 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.

ARGX-119 - FDA Regulatory Timeline and Events

ARGX-119 is a drug developed by argenex for the following indication: In Congenital Myasthenic Syndromes. 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.

efgartigimod - FDA Regulatory Timeline and Events

efgartigimod is a drug developed by argenex for the following indication: To reduce pathogenic immunoglobulin G (IgG). 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.

VYVGART (efgartigimod alfa) - FDA Regulatory Timeline and Events

VYVGART (efgartigimod alfa) is a drug developed by argenex for the following indication: For Adults with Primary Immune Thrombocytopenia. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

VYVGART Hytrulo - FDA Regulatory Timeline and Events

VYVGART Hytrulo is a drug developed by argenex for the following indication: Injection for Subcutaneous Use in Generalized Myasthenia Gravis. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

argenex FDA Events - Frequently Asked Questions

Yes, argenex (ARGX) has received FDA approval for multiple therapies, including VYVGART Hytrulo and VYVGART (efgartigimod alfa). This page tracks recent and historical FDA regulatory events related to argenex's drug portfolio.

In the past two years, argenex (ARGX) has reported FDA regulatory activity for the following drugs: VYVGART (efgartigimod alfa), VYVGART Hytrulo, ARGX-119, efgartigimod and ALKIVIA.

The most recent FDA-related event for argenex occurred on June 30, 2025, involving ARGX-119. The update was categorized as "Provided Update," with the company reporting: "argenx SE announced its plan to advance the clinical development of ARGX-119, a first-in-class agonist antibody to muscle-specific kinase (MuSK), to a registrational study in patients with congenital myasthenic syndromes (CMS) following the analysis of topline data from the Phase 1b study."

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

  • For Adults with Primary Immune Thrombocytopenia - VYVGART (efgartigimod alfa)
  • Injection for Subcutaneous Use in Generalized Myasthenia Gravis - VYVGART Hytrulo
  • In Congenital Myasthenic Syndromes - ARGX-119
  • To reduce pathogenic immunoglobulin G (IgG) - efgartigimod
  • In Idiopathic Inflammatory Myopathies - ALKIVIA

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