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Viridian Therapeutics (VRDN) FDA Events

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FDA Events for Viridian Therapeutics (VRDN)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Viridian Therapeutics (VRDN). Over the past two years, Viridian Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Veligrotug, VRDN-001, VRDN-003, and VRDN-006. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Viridian Therapeutics' Drugs in FDA Review

Veligrotug - FDA Regulatory Timeline and Events

Veligrotug is a drug developed by Viridian Therapeutics for the following indication: For Chronic Thyroid Eye Disease. 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.

VRDN-001 - FDA Regulatory Timeline and Events

VRDN-001 is a drug developed by Viridian Therapeutics for the following indication: Thyroid Eye Disease (TED). 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.

VRDN-003 - FDA Regulatory Timeline and Events

VRDN-003 is a drug developed by Viridian Therapeutics for the following indication: for patients with moderate-to-severe TED. 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.

VRDN-006 - FDA Regulatory Timeline and Events

VRDN-006 is a drug developed by Viridian Therapeutics for the following indication: a neonatal Fc receptor. 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.

Viridian Therapeutics FDA Events - Frequently Asked Questions

In the past two years, Viridian Therapeutics (VRDN) 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, Viridian Therapeutics (VRDN) has reported FDA regulatory activity for the following drugs: VRDN-001, Veligrotug, VRDN-006 and VRDN-003.

The most recent FDA-related event for Viridian Therapeutics occurred on May 20, 2025, involving Veligrotug. The update was categorized as "Positive Data," with the company reporting: "Viridian Therapeutics, Inc announced positive long-term durability data from the THRIVE phase 3 clinical trial of veligrotug ("veli"), an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, in patients with active thyroid eye disease (TED)."

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

  • Thyroid Eye Disease (TED) - VRDN-001
  • For Chronic Thyroid Eye Disease - Veligrotug
  • a neonatal Fc receptor - VRDN-006
  • for patients with moderate-to-severe TED. - VRDN-003

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