Business
Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform
STOCKHOLM, August 19, 2025--Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physi
About this update from Xspray Pharma Ab
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1024,"height":512,"url":"https://media.zenfs.com/en/business-wire.com/0f328449154dc78d025af07e94eb17bf"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/TBvIg9Jjg53ig.ijrfnYaw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQ4MDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/0f328449154dc78d025af07e94eb17bf","width":960,"height":480},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/sAOq1faLy7r_AcN.7DSODw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIwNDg7aD0xMDI0O2NmPXdlYnA-/https://media.zenfs.com/en/business-wire.com/0f328449154dc78d025af07e94eb17bf","width":1024,"height":512}},"lazy":false},{"type":"text","content":"STOCKHOLM, August 19, 2025--(BUSINESS WIRE)--Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three hours of fasting, currently included in the reference product’s so-called boxed warning, is not expected to apply to XS003. This may simplify treatment and improve adherence.","length":904,"tagName":"p"},{"type":"text","content":"XS003 is an improved formulation of nilotinib (Tasigna®) and developed using the company’s proprietary HyNap™ technology.","length":121,"tagName":"p"},{"type":"text","content":""Patients with chronic leukemia live not only with their disease—but also with side effects from medications, often related to food interaction and concomitant treatments. Our proprietary HyNap technology addresses these challenges and may help improve treatment outcomes and quality of life for this patient group. Our goal is to develop and commercialize a portfolio of next-generation Protein Kinase Inhibitor products with stable absorption, low variability, and minimal food inte...