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.
- Drug:
- Ensifentrine
- Announced Date:
- May 6, 2025
- Indication:
- Chronic obstructive pulmonary disease (COPD)
Announcement
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.
AI Summary
Verona Pharma plc has announced that it will present a total of ten posters at the American Thoracic Society Conference 2025. Among these, seven posters feature new analyses from its Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine), an innovative inhaled treatment designed for COPD. The studies include subgroup evaluations where Ohtuvayre is used as monotherapy and in patients with COPD and other health conditions such as cardiac disorders and type 2 diabetes, highlighting its dual bronchodilator and non-steroidal anti-inflammatory effects.
In addition to the clinical data, two posters will present nonclinical results—one detailing a rat tissue distribution study and another exploring antifibrotic effects in a bleomycin model—along with one poster presenting real-world data analysis. These findings, published on the ATS website and in a leading respiratory journal, underscore the potential of Ohtuvayre for a broad COPD population.
Read Announcement- Drug:
- Ensifentrine
- Announced Date:
- September 30, 2024
- Indication:
- Chronic obstructive pulmonary disease (COPD)
Announcement
Verona Pharma plc announces four oral presentations and two posters on analyses from its successful Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease ("COPD") will be presented at CHEST Annual Meeting ("CHEST") 2024.
AI Summary
Verona Pharma has announced that it will present four oral presentations and two posters at the CHEST Annual Meeting 2024. These presentations will detail analyses from its successful Phase 3 ENHANCE studies of Ohtuvayre (ensifentrine), an inhaled therapy designed for the treatment of chronic obstructive pulmonary disease (COPD). The studies highlight the drug’s dual action as both a bronchodilator and a non-steroidal anti-inflammatory agent. The data will emphasize improvements in lung function, symptom relief, enhanced quality of life, and reductions in exacerbation rates across various COPD patient subgroups. This novel approach is significant as it marks the first innovative inhaled maintenance treatment for COPD in over 20 years. The upcoming presentations underscore Ohtuvayre’s potential to meet a long-standing need in COPD care, offering hope for patients with both moderate and severe disease.
Read Announcement- Drug:
- Ensifentrine
- Announced Date:
- September 5, 2024
- Indication:
- Chronic obstructive pulmonary disease (COPD)
Announcement
Verona Pharma plc announces one oral presentation and 3 posters on additional analyses from its successful Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the treatment of chronic obstructive pulmonary disease ("COPD") will be presented at the European Respiratory Society ("ERS") International Congress 2024.
AI Summary
Verona Pharma plc has announced that it will share new findings from its Phase 3 ENHANCE studies on Ohtuvayre™ (ensifentrine) at the ERS International Congress 2024. The company plans one oral presentation and three posters focusing on additional analyses of the drug’s efficacy and safety in treating chronic obstructive pulmonary disease (COPD). The data include improvements in lung function, reduced rates of exacerbations, and benefits across different patient subgroups, such as those with chronic bronchitis and European patients.
Ohtuvayre is a first-in-class, selective dual inhibitor of PDE3 and PDE4, offering both bronchodilator and non-steroidal anti-inflammatory effects. Experts, including Professor Jadwiga Wedzicha from Imperial College London, highlighted the therapy’s potential to significantly impact COPD treatment by addressing both airflow obstruction and inflammation. These presentations underscore the promise of Ohtuvayre as the first novel inhaled COPD maintenance treatment in over two decades.
Read Announcement- Drug:
- Ensifentrine
- Announced Date:
- June 27, 2024
- Indication:
- Chronic obstructive pulmonary disease (COPD)
Announcement
Ligand Pharmaceuticals Incorporated announced that its partner Verona Pharma plc has received approval from the U.S. Food and Drug Administration (FDA) for Ohtuvayre™ (ensifentrine).
AI Summary
Ligand Pharmaceuticals Incorporated announced that its partner, Verona Pharma plc, has received FDA approval for Ohtuvayre™ (ensifentrine). This approval marks the first inhaled therapy in more than 20 years with a novel mechanism of action for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. Ohtuvayre combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule and is designed to be delivered via a standard jet nebulizer, making it easier for patients to use.
With this milestone, Ligand has earned a $5.8 million payment and is set to receive an additional $13.8 million once the commercial launch begins in the third quarter of 2024. The company is also set to receive a low single-digit royalty on worldwide net sales, further strengthening its commercial stage portfolio, which now includes 11 key products.
Read Announcement- Drug:
- Ensifentrine
- Announced Date:
- June 26, 2024
- Indication:
- Chronic obstructive pulmonary disease (COPD)
Announcement
Verona Pharma plc announces the US Food and Drug Administration ("FDA") approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.
AI Summary
Verona Pharma plc announced that the US FDA has approved its new drug, Ohtuvayre (ensifentrine), for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. This approval is a major milestone because Ohtuvayre is the first inhaled treatment with a novel mechanism of action for COPD in over 20 years. The drug works as a selective dual inhibitor of the enzymes PDE3 and PDE4, offering both bronchodilator and non-steroidal anti-inflammatory benefits within a single molecule. It is delivered directly to the lungs via a standard jet nebulizer, making it easier to use without the need for high inspiratory flow rates or complex breathing coordination. Verona Pharma plans to launch Ohtuvayre in the third quarter of 2024, aiming to provide much-needed relief for the millions of COPD patients who experience daily breathing challenges.
Read Announcement- Drug:
- Ensifentrine
- Announced Date:
- May 2, 2024
- Indication:
- Chronic obstructive pulmonary disease (COPD)
Announcement
Verona Pharma announces eight posters, including two mini oral symposia, on additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for the treatment of chronic obstructive pulmonary disease ("COPD") will be presented at the American Thoracic Society International Conference ("ATS") 2024.
AI Summary
Verona Pharma announced it will present eight posters, including two mini oral symposia, at the ATS 2024 conference. These presentations feature additional analyses from the successful Phase 3 ENHANCE studies on ensifentrine, an investigational treatment for COPD. The data, derived from pooled analyses of the ENHANCE-1 and ENHANCE-2 trials, demonstrate significant reductions in both the rate and risk of COPD exacerbations. The findings suggest that ensifentrine, a novel selective dual inhibitor of PDE3 and PDE4, may improve lung function and reduce symptoms when used alongside standard COPD treatments such as LAMA or LABA/ICS therapies.
The mini symposia will highlight breakthrough data and provide insights from leading clinical experts on the potential of ensifentrine as a novel inhaled treatment. If FDA approved, this therapy could offer the first new inhaled mechanism for COPD maintenance treatment in over 20 years.
Read Announcement- Drug:
- Ensifentrine
- Announced Date:
- May 2, 2024
- Estimated Event Date Range:
- June 26, 2024 - June 26, 2024
- Target Action Date:
- June 26, 2024
- Indication:
- Chronic obstructive pulmonary disease (COPD)
Announcement
Verona Pharma announced that PDUFA Target Action Date of June 26, 2024
AI Summary
Verona Pharma announced new findings from its Phase 3 ENHANCE studies at the American Thoracic Society International Conference 2024. The studies showed that ensifentrine, an investigational dual inhibitor of PDE3 and PDE4, can improve lung function and reduce the risk of exacerbations in COPD patients. A key point in the announcement is that the US Food and Drug Administration has set a PDUFA Target Action Date of June 26, 2024, for reviewing the company’s NDA for ensifentrine. If approved, ensifentrine could become the first novel inhaled non-steroidal treatment for COPD in over 20 years, offering both bronchodilator and anti-inflammatory benefits in one therapy.
This FDA review represents a crucial milestone for Verona Pharma as they look forward to potentially introducing a much-needed new option for chronic respiratory disease management.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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 7/12/2025 by MarketBeat.com Staff
