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Verona Pharma plc was a respiratory biopharmaceutical company whose updates centered on Ohtuvayre (ensifentrine), a selective dual PDE3 and PDE4 inhibitor for maintenance treatment of chronic obstructive pulmonary disease in adults. Company news covered Ohtuvayre commercialization, analyses from the Phase 3 ENHANCE studies in COPD, respiratory-disease pipeline work including non-cystic fibrosis bronchiectasis, and financial results tied to the product launch.
Verona Pharma became a wholly owned subsidiary of Merck after the completed acquisition in 2025, and its American Depositary Shares ceased trading on the Nasdaq Global Market. Later corporate news reflects the completed status change, material agreements, shareholder voting matters, capital-structure disclosures, and governance matters.
Ritedose, the largest CDMO in the US specializing in sterile Blow Fill Seal production, has partnered with Verona Pharma (Nasdaq: VRNA) to develop and manufacture Ohtuvayre (ensifentrine), a novel COPD treatment. The FDA approved Ohtuvayre on June 26 for maintenance treatment of COPD in adults, marking the first inhaled product with a new mechanism of action in over 20 years. Ohtuvayre, delivered via standard jet nebulizer, is a first-in-class PDE3 and PDE4 inhibitor that aims to redefine COPD treatment. With COPD affecting over 480 million people globally and 14 million in the US, this partnership between Ritedose and Verona Pharma brings a significant advancement to the respiratory market.
Verona Pharma (Nasdaq: VRNA) announces presentations of additional analyses from its Phase 3 ENHANCE studies on Ohtuvayre™ (ensifentrine) for COPD treatment at the ERS International Congress 2024. The presentations include one oral and three posters, highlighting Ohtuvayre's efficacy and safety in various COPD patient subgroups.
Ohtuvayre, a first-in-class dual inhibitor of PDE3 and PDE4, combines bronchodilator and anti-inflammatory effects. Key findings include improvements in lung function, reduced exacerbation rates, and enhanced quality of life across different patient populations. The analyses support Ohtuvayre's potential to benefit a broad range of COPD patients, marking the first novel inhaled mechanism for COPD maintenance treatment in over 20 years.
Verona Pharma (NASDAQ: VRNA) announced that Ohtuvayre (ensifentrine) is now available in the US for COPD maintenance treatment. Key highlights:
- Over 2,000 HCP visits conducted and 100+ unique HCPs have prescribed Ohtuvayre
- Submitted IND for ensifentrine-glycopyrrolate combination therapy
- Plans to initiate Phase 2 trial for non-cystic fibrosis bronchiectasis in Q3 2024
- Cash position of $404.6 million as of June 30, 2024
- Q2 2024 R&D expenses increased to $19.4 million (Q2 2023: -$2.5 million)
- Q2 2024 SG&A expenses rose to $49.0 million (Q2 2023: $12.4 million)
- Q2 2024 net loss of $70.8 million (Q2 2023: $8.8 million loss)
The company believes its current cash position will fund operations beyond 2026, including Ohtuvayre's US commercial launch.
Verona Pharma (Nasdaq: VRNA) has announced its participation in the 44th Annual Canaccord Growth Conference. The company's senior management will present a company overview on Tuesday, August 13, 2024, at 1:30 p.m. EDT / 6:30 p.m. BST.
Investors and interested parties can access a webcast of the event through the Events and Presentations link on the Investors page of Verona Pharma's website, www.veronapharma.com. This presentation provides an opportunity for the company to showcase its progress and future plans to a wider audience of potential investors and industry professionals.
For those seeking additional information, Verona Pharma has provided contact details for investor relations, US investor enquiries, and international/US media enquiries.
Verona Pharma plc (Nasdaq: VRNA) has announced it will report its financial results for the second quarter ended June 30, 2024, on Thursday, August 8, 2024. The company will also host an investment community conference call at 9:00 a.m. EDT / 2:00 p.m. BST to discuss these financial results and provide a corporate update.
To participate in the call, investors can dial +1-833-816-1396 (US callers) or +1-412-317-0489 (international callers) and ask to join the Verona Pharma call. A live webcast will be available on the Events and Presentations link on the Investors page of the company's website, with an audio replay accessible for 90 days.
Verona Pharma announced that the FDA has approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of COPD in adults. Ohtuvayre is the first inhaled treatment in over 20 years offering both bronchodilation and non-steroidal anti-inflammatory effects. The drug is unique as a selective dual inhibitor of PDE3 and PDE4 enzymes and is administered via a standard jet nebulizer.
In clinical trials, Ohtuvayre showed significant benefits when used alone or with other treatments and was well-tolerated by patients with moderate to severe COPD. Verona Pharma plans to launch Ohtuvayre in Q3 2024 through specialized pharmacies.
Verona Pharma announces its financial results for the first quarter of 2024 and provides a corporate update. The PDUFA Target Action Date for Ensifentrine is set for June 26, 2024, with preparations underway for a potential US launch in the third quarter. The company's strong balance sheet, supported by a recent financing of up to $650 million, is geared towards commercialization and pipeline expansion. Key milestones include launch preparations, COPD disease awareness campaigns, presentations at conferences, and upcoming clinical trials. Financially, cash position remains strong, with R&D expenses and SG&A expenses detailed for the quarter.
Verona Pharma secured $650 million in strategic financing from Oaktree and OMERS to support the US commercial launch of ensifentrine and expand clinical activities. The non-dilutive funding extends the cash runway beyond 2026, providing financial flexibility for growth.
Verona Pharma plc will present additional analyses from its successful Phase 3 ENHANCE studies with ensifentrine for COPD treatment at ATS 2024. The investigational product, ensifentrine, has shown promising results in reducing exacerbations and improving lung function, with potential FDA approval as the first novel inhaled COPD treatment in over 20 years.
Summary not available.