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Xspray Pharma AB ( (SE:XSPRAY) ) has issued an announcement.
Xspray Pharma AB has received a Complete Response Letter from the FDA regarding its New Drug Application for Dasynoc™, due to Good Manufacturing Practice observations at a contract manufacturer, which are delaying the drug’s approval. The company is actively working with the manufacturer and the FDA to address these issues, aiming for a swift resubmission once corrective actions are completed. Despite this setback, Xspray’s other development programs are progressing as planned, with the NDA review for XS003 expected to begin soon.
More about Xspray Pharma AB
Xspray Pharma AB is a pharmaceutical company specializing in the development of 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, focusing on oncology, the largest segment in this field. Xspray Pharma’s lead drug candidate, Dasynoc®, is an amorphous form of dasatinib, designed to be bioequivalent at a lower dose and compatible with proton pump inhibitors, offering significant advantages for patients with chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).
Average Trading Volume: 83,499
Technical Sentiment Signal: Buy
Current Market Cap: SEK2.42B
See more data about XSPRAY stock on TipRanks’ Stock Analysis page.