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Xspray Pharma AB ( (SE:XSPRAY) ) just unveiled an announcement.
Xspray Pharma AB has received acknowledgment from the FDA for its re-submitted New Drug Application for Dasynoc®, with a PDUFA date set for October 7, 2025. This development is crucial for the company’s plans to launch Dasynoc® in the US market, offering a new dasatinib drug option for ALL and CML patients, pending market approval.
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 in the oncology market segment by offering enhanced PKIs for cancer treatment. Its lead product, Dasynoc®, is an amorphous form of dasatinib, designed to be bioequivalent at a lower dose and compatible with proton pump inhibitors, providing significant advantages for patients with CML and ALL.
Average Trading Volume: 19,708
Current Market Cap: SEK1.03B
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