{"id":61745,"date":"2025-08-19T16:05:29","date_gmt":"2025-08-19T14:05:29","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/xspray-pharma-submits-xs003-to-the-fda-the-companys-second-product-candidate-from-the-hynap-platform\/"},"modified":"2025-08-19T16:05:29","modified_gmt":"2025-08-19T14:05:29","slug":"xspray-pharma-submits-xs003-to-the-fda-the-companys-second-product-candidate-from-the-hynap-platform","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/xspray-pharma-submits-xs003-to-the-fda-the-companys-second-product-candidate-from-the-hynap-platform\/","title":{"rendered":"Xspray Pharma Submits XS003 to the FDA \u2013 The Company\u2019s Second Product Candidate from the HyNap Platform"},"content":{"rendered":"
\n

STOCKHOLM–(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\u00ae. 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\u2019s improved food interaction profile, the warning about three hours of fasting, currently included in the reference product\u2019s so-called boxed warning, is not expected to apply to XS003. This may simplify treatment and improve adherence.<\/b><\/p>\n

<\/a>
<\/a><\/p>\n

\nXS003 is an improved formulation of nilotinib (Tasigna\u00ae) and developed using the company\u2019s proprietary HyNap\u2122 technology.<\/p>\n

\n\u201cPatients with chronic leukemia live not only with their disease\u2014but 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 interaction. With XS003, we now have two product candidates under FDA review with strong clinical potential, addressing a total U.S. market worth USD 2.7 billion,\u201d<\/i> says Per Andersson, CEO of Xspray Pharma.<\/p>\n

\nData from registration studies demonstrate bioequivalence with the reference product, despite XS003 being administered at less than half the dose of the reference product. In addition, the studies confirm clearly improved dose linearity, which may provide physicians with better predictability when adjusting doses, and thereby a greater ability to achieve improved treatment outcomes. The uptake of XS003 is only slightly affected when taken with food, while the reference product is significantly affected as reflected in their label (28% vs. 82%). This may indicate improved control and a lower risk of side effects when taken with food.<\/p>\n

\nXspray expects the FDA to initiate its review within 60 days, with a regulatory decision anticipated approximately eight months thereafter.<\/p>\n

\nGlobal 2024 nilotinib sales reached USD 1.67 billion in 2024, of which USD 850 million came from the U.S.<\/p>\n

\nAbout Xspray Pharma<\/b><\/p>\n

\nXspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap\u2122 technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies. Xspray Pharma\u2019s shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY). For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com<\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nFor further information, please contact:<\/b>
Jacob Nyberg, IR
\n
Xspray Pharma AB (publ)
\n
Tel: + 46 (0) 70 767 08 83
\n
E-mail: ir@xspray.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

STOCKHOLM–(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\u00ae. XS003 demonstrates the lowest documented food … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61745","6":"format-standard","7":"category-industry"},"yoast_head":"\nXspray Pharma Submits XS003 to the FDA \u2013 The Company\u2019s Second Product Candidate from the HyNap Platform - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/xspray-pharma-submits-xs003-to-the-fda-the-companys-second-product-candidate-from-the-hynap-platform\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Xspray Pharma Submits XS003 to the FDA \u2013 The Company\u2019s Second Product Candidate from the HyNap Platform - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"STOCKHOLM–(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). 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