In 2024, Verona Pharma (VRNA) experienced significant growth, with its share price tripling over just seven and a half months. This remarkable increase followed the company's transition from a clinical-stage entity to a commercial one in June, after receiving FDA approval for its flagship drug, Ensifentrine.
Ensifentrine, sold under the brand name Ohtuvayre, is approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. It stands out as the first inhaled treatment with a novel mechanism introduced for COPD maintenance in over two decades, achieving FDA approval on June 26, 2024.
COPD is a significant health concern in the United States, representing one of the leading causes of mortality. The disease encompasses chronic lung conditions such as chronic bronchitis and emphysema, all characterized by ongoing inflammation in the airways.
Launched in August 2024, Ohtuvayre accumulated net sales of $5.6 million by the end of the third quarter on September 30, 2024. The company projects a multi-billion-dollar market opportunity for this product.
Verona is currently exploring Ensifentrine in two phase II trials. One is a dose-ranging study with glycopyrrolate, a long-acting muscarinic antagonist (LAMA), supporting a nebulized fixed-dose combination program with Ensifentrine for COPD treatment. Additionally, another trial is evaluating the efficacy and safety of nebulized Ensifentrine in patients with non-cystic fibrosis bronchiectasis.
Moreover, a crucial phase III trial for Ensifentrine as a COPD maintenance treatment is underway in China, conducted by Verona's partner, Nuance Pharma, in Greater China. Results from this study are anticipated in 2025.
When we initially highlighted VRNA to our readers on May 17, 2024, it was priced at $13.42. As of yesterday's market close, the stock reached an unprecedented high of $47.02, marking a 250% increase in seven and a half months.
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