Dasynoc (XS004 dasatinib)
Chronic Myeloid Leukemia (CML), Acute Lymphoblastic Leukemia (ALL)
NDA SubmittedUnder FDA Review (PDUFA Aug 25, 2026)
Key Facts
Indication
Chronic Myeloid Leukemia (CML), Acute Lymphoblastic Leukemia (ALL)
Phase
NDA Submitted
Status
Under FDA Review (PDUFA Aug 25, 2026)
Company
About Xspray Pharma
Xspray Pharma is a clinical-stage oncology company focused on developing best-in-class, improved versions of marketed Protein Kinase Inhibitor (PKI) drugs. Its core strategy leverages the patented HyNap technology platform to create amorphous solid dispersions that circumvent secondary crystalline patents, enabling earlier market entry post compound patent expiry while offering superior pharmacokinetic profiles. The company is on the cusp of its first commercial launch with Dasynoc in the US, has a pipeline of follow-on candidates, and has established key commercial partnerships to drive market penetration in the multi-billion dollar PKI segment.
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