Latest news with #XsprayPharma
Business Wire
an hour ago
- Business
- Business Wire
Xspray Pharma Submits XS003 to the FDA – The Company's Second Product Candidate from the HyNap Platform
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®. 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. XS003 is an improved formulation of nilotinib (Tasigna®) and developed using the company's proprietary HyNap™ technology. '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 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,' says Per Andersson, CEO of Xspray Pharma. Data 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. Xspray expects the FDA to initiate its review within 60 days, with a regulatory decision anticipated approximately eight months thereafter. Global 2024 nilotinib sales reached USD 1.67 billion in 2024, of which USD 850 million came from the U.S. About Xspray Pharma Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ 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's 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
Yahoo
12-08-2025
- Business
- Yahoo
Xspray Pharma Signs License Agreement with Handa Therapeutics – to Receive up to Double-Digit Royalty on Handa's Net Proceeds
Xspray Pharma ("Xspray") has entered into a license agreement with Handa Therapeutics ("Handa") granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa's net proceeds. STOCKHOLM, August 12, 2025--(BUSINESS WIRE)--This is the first out-licensing from Xspray's broad patent portfolio and marks an important milestone in capitalizing on its intellectual property assets. The company's core strategy to develop and commercialize improved PKI-drugs using its patented HyNap technology remains unchanged. Its lead product candidate Dasynoc awaits FDA-approval with a PDUFA date of October 7, 2025. However, further licensing agreements may be considered on a case-by-case basis. "The agreement confirms the value of our patent portfolio and demonstrates that our long-term work to build our comprehensive patent portfolio is paying off. As for the dasatinib market, I'm convinced that when Dasynoc is launched it will be seen as the premium product in its market segment as it combines pH-independent absorption with lower dose strength and high precision, eliminating sensitivity to all acid-reducing agents," says Per Andersson, CEO of Xspray Pharma. The agreement further ensures that Xspray's planned launch of Dasynoc can proceed without being affected by any United States regulatory exclusivities that may be associated with Handa's product. Handa's dasatinib product has not yet been launched. About Xspray Pharma Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ 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's 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 View source version on Contacts For further information, please contact: Jacob Nyberg, IRXspray Pharma AB (publ)Tel: + 46 (0) 70 767 08 83E-mail: ir@
Business Wire
12-08-2025
- Business
- Business Wire
Xspray Pharma Signs License Agreement with Handa Therapeutics – to Receive up to Double-Digit Royalty on Handa's Net Proceeds
STOCKHOLM--(BUSINESS WIRE)--This is the first out-licensing from Xspray's broad patent portfolio and marks an important milestone in capitalizing on its intellectual property assets. The company's core strategy to develop and commercialize improved PKI-drugs using its patented HyNap technology remains unchanged. Its lead product candidate Dasynoc awaits FDA-approval with a PDUFA date of October 7, 2025. However, further licensing agreements may be considered on a case-by-case basis. 'The agreement confirms the value of our patent portfolio and demonstrates that our long-term work to build our comprehensive patent portfolio is paying off. As for the dasatinib market, I'm convinced that when Dasynoc is launched it will be seen as the premium product in its market segment as it combines pH-independent absorption with lower dose strength and high precision, eliminating sensitivity to all acid-reducing agents,' says Per Andersson, CEO of Xspray Pharma. The agreement further ensures that Xspray's planned launch of Dasynoc can proceed without being affected by any United States regulatory exclusivities that may be associated with Handa's product. Handa's dasatinib product has not yet been launched. About Xspray Pharma Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ 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's 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
