RedHill Biopharma Ltd. (NASDAQ: RDHL) shares jumped early on Monday after the firm announced that the U.S. Food and Drug Administration (FDA) approved Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults.
RedHill expects to launch Talicia in the United States in the first quarter of 2020 with its dedicated sales force. The U.S. launch will target more than 2 million patients estimated to be treated for H. pylori infection annually.
H. pylori affects roughly 35% of U.S. adult population. It is classified as a Group I carcinogen and is the strongest risk factor for the development of peptic ulcer disease, gastritis and non-cardia gastric cancer.
H. pylori is a type of bacteria that lives in the digestive tract. After many years they can cause sores, or ulcers, in the lining of the stomach or upper part of the small intestine. This can lead to stomach cancer over time.
Dror Ben-Asher, CEO of RedHill, commented:
The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases. We thank the patients, researchers and clinical staff who participated in the studies of Talicia and the RedHill team and vendors for this important milestone achieved by their commitment and hard work. We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket.
Shares of RedHill traded up more than 14% early Monday at $7.93, in a 52-week range of $5.13 to $9.57. The consensus price target is $20.83.