Swedish pharmaceutical company XSpray Pharma AB (STO:XSPRAY) said on Tuesday that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for XS003 (nilotinib) under the 505(b)(2) regulatory pathway.

This acceptance confirms that the NDA is complete and under full review. The FDA has set a PDUFA date of 18 June 2026 for the expected decision on the application.

XS003 is an improved formulation of nilotinib for the treatment of chronic myeloid leukemia (CML), developed using Xspray's HyNap technology. Clinical data show bioequivalence to the reference product at less than half the dose and a reduced food effect of 29% compared to 82% for Tasigna, potentially allowing administration with or without food. This may mitigate the need for boxed warning text related to food interactions, subject to final FDA labelling.

Together with Xspray's first product candidate Dasynoc, XS003 targets a US market valued at approximately USD2.7bn. XS003 is manufactured at the same external facility as Dasynoc.