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Verona Pharma PLC American Depositary Share (VRNA) FDA Events

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FDA Events for Verona Pharma PLC American Depositary Share (VRNA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Verona Pharma PLC American Depositary Share (VRNA). Over the past two years, Verona Pharma PLC American Depositary Share has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Ensifentrine. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Ensifentrine - FDA Regulatory Timeline and Events

Ensifentrine is a drug developed by Verona Pharma PLC American Depositary Share for the following indication: Chronic obstructive pulmonary disease (COPD). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Verona Pharma PLC American Depositary Share FDA Events - Frequently Asked Questions

Yes, Verona Pharma PLC American Depositary Share (VRNA) has received FDA approval for Ensifentrine. This page tracks recent and historical FDA regulatory events related to Verona Pharma PLC American Depositary Share's drug portfolio.

In the past two years, Verona Pharma PLC American Depositary Share (VRNA) has reported FDA regulatory activity for Ensifentrine.

The most recent FDA-related event for Verona Pharma PLC American Depositary Share occurred on May 6, 2025, involving Ensifentrine. The update was categorized as "Poster Presentation," with the company reporting: "Verona Pharma plc announces ten posters including seven additional analyses from its Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease ("COPD"), two from nonclinical studies, and one from a real-world data analysis, will be presented at the American Thoracic Society Conference ("ATS") 2025."

Currently, Verona Pharma PLC American Depositary Share has one therapy (Ensifentrine) targeting the following condition: Chronic obstructive pulmonary disease (COPD).

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:VRNA) was last updated on 7/9/2025 by MarketBeat.com Staff
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