FDA Approves Verona Pharma's Ensifentrine for COPD, Stock Jumps 20%

Verona Pharma's stock surged 20% in after-hours trading after the FDA approved Ohtuvayre (ensifentrine) for COPD. This first-in-class drug, targeting PDE3 and PDE4, offers a dual bronchodilator and anti-inflammatory effect. Launching in Q3, analysts project peak sales of $1B.

The US Food and Drug Administration (FDA) made a significant stride in respiratory healthcare by approving Verona Pharma's first-in-class COPD drug, Ohtuvayre, or ensifentrine, on June 26, 2024 [1]. This dual bronchodilator and anti-inflammatory medication, which targets PDE3 and PDE4, is projected to generate peak sales of $1 billion [2].

Ensifentrine, a selective dual inhibitor of PDE3 and PDE4, combines bronchodilator and non-steroidal anti-inflammatory effects in a single molecule [1]. The drug's unique mechanism of action sets it apart from existing COPD treatments, potentially revolutionizing the maintenance treatment landscape for this condition.

The FDA's decision follows extensive clinical data demonstrating ensifentrine's efficacy and safety. The ENHANCE-1 and ENHANCE-2 trials, which were presented at the American Thoracic Society International Conference (ATS) 2024, showed that ensifentrine significantly improved lung function across primary and secondary endpoints [1]. Moreover, ensifentrine reduced the rate and risk of moderate/severe exacerbations in a pooled analysis of these trials [1].

Ensifentrine's benefits extend beyond bronchodilation and anti-inflammation. The drug also reduced the rate of exacerbations regardless of eosinophil count and delayed progression of exacerbations [1]. Additionally, it showed promise in improving dyspnea, a common and debilitating symptom of COPD [1].

The FDA's approval of Ohtuvayre represents a significant milestone for Verona Pharma. As a pioneer in PDE-based respiratory treatments, Verona Pharma aims to continue pushing the boundaries of healthcare innovation. With the first novel inhaled mechanism for the maintenance treatment of COPD in over two decades now on the market, the Company is poised to make a substantial impact on respiratory healthcare [1].

[1] Verona Pharma. (2024, May 2). Verona Pharma to present additional analyses of positive phase 3 enhance studies in COPD at ats 2024. Retrieved from https://www.veronapharma.com/news/verona-pharma-to-present-additional-analyses-of-positive-phase-3-enhance-studies-in-copd-at-ats-2024/
[2] Yahoo Finance. (2024, June 27). Verona Pharma Inc. (VRNA) Stock Price, Stock Quote. Retrieved from https://finance.yahoo.com/quote/VRNA