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Xspray Pharma AB ( (SE:XSPRAY) ) has provided an announcement.
Xspray Pharma AB has achieved a significant regulatory milestone with the successful completion of the FDA’s Pre-Approval Inspection for its product candidate, Dasynoc, confirming compliance with current Good Manufacturing Practice standards. This milestone reduces regulatory uncertainty as the company prepares for Dasynoc’s commercial launch, an improved formulation of dasatinib for leukemia treatment, leveraging the proprietary HyNap™ platform for better drug delivery and potential expansion into other oncology indications.
More about Xspray Pharma AB
Xspray Pharma AB is a pharmaceutical company focused on developing improved versions of marketed protein kinase inhibitors (PKIs) using its patented HyNap™ technology platform. The company aims to lead the market in enhanced PKIs for cancer treatment, with a portfolio that includes drug candidates like Dasynoc®, XS003-nilotinib, XS008-axitinib, and XS025-cabozantinib. Xspray Pharma’s lead candidate, Dasynoc®, is an amorphous form of dasatinib, offering bioequivalence at a lower dose and compatibility with proton pump inhibitors, beneficial for patients with chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).
Average Trading Volume: 28,612
Current Market Cap: SEK1.41B
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