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Veracyte (VCYT) FDA Events

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FDA Events for Veracyte (VCYT)

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

Veracyte's Drugs in FDA Review

STAMPEDE - FDA Regulatory Timeline and Events

STAMPEDE is a drug developed by Veracyte for the following indication: In Patients with Metastatic Prostate Cancer. 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.

VANDAAM Study - FDA Regulatory Timeline and Events

VANDAAM Study is a drug developed by Veracyte for the following indication: Physicians tailor treatment decisions for men with prostate cancer. 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.

Veracyte FDA Events - Frequently Asked Questions

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

In the past two years, Veracyte (VCYT) has reported FDA regulatory activity for the following drugs: VANDAAM Study and STAMPEDE.

The most recent FDA-related event for Veracyte occurred on October 2, 2024, involving VANDAAM Study. The update was categorized as "Provided Update," with the company reporting: "Veracyte, Inc announced that new data from the multicenter, prospective VANDAAM trial show that the Decipher Prostate Genomic Classifier accurately predicts aggressive prostate cancer among African American men with early-stage disease."

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

  • Physicians tailor treatment decisions for men with prostate cancer - VANDAAM Study
  • In Patients with Metastatic Prostate Cancer - STAMPEDE

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