Xspray Wins FDA Nod on Nilopki Name, Sets Stage for Dual CML Drug Launch in U.S.

An update from Xspray Pharma AB ( (SE:XSPRAY) ) is now available.

Xspray Pharma has secured U.S. FDA acceptance of Nilopki as the trade name for its nilotinib-based drug candidate XS003, an improved amorphous formulation of Tasigna for treating chronic myeloid leukemia. Developed on the company’s HyNap platform, Nilopki is under FDA review via the 505(b)(2) pathway, with a decision date in June 2026 and plans for a U.S. launch in the second half of 2026 alongside Dasynoc, subject to approvals.

Nilopki is designed to materially reduce food interaction and remove the current fasting and boxed-warning constraints seen with Tasigna, enabled by a 52 percent dose reduction while maintaining bioavailability. By coordinating the launches of Nilopki and Dasynoc to the same CML prescribers and patients and leveraging its EVERSANA partnership, Xspray aims to capture synergies in commercialization and strengthen its competitive position in the growing U.S. CML market.

More about Xspray Pharma AB

Xspray Pharma AB is a Swedish oncology-focused drug developer building a portfolio of enhanced, amorphous versions of established protein kinase inhibitors. Its lead candidates include Dasynoc and Nilopki for chronic myeloid leukemia, as well as XS008 and XS025 for kidney cancer, targeting a U.S. CML market worth about $6.6 billion in 2025.

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Current Market Cap: SEK1.39B

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