Xspray Pharma Resubmits FDA Application for Leukemia Drug Dasynoc

The latest update is out from Xspray Pharma AB ( (SE:XSPRAY) ).

Xspray Pharma has re-submitted its New Drug Application to the U.S. Food and Drug Administration for Dasynoc, its lead amorphous dasatinib candidate for treating chronic myeloid leukemia and acute lymphoblastic leukemia. The move follows a Complete Response Letter issued in October 2025 and incorporates additional data aimed at resolving the regulator’s concerns over medication error risk and manufacturing controls.

The updated filing includes results from a qualitative human factors study showing strong prescriber understanding of new tablet strengths, along with documentation supporting the effectiveness of manufacturing measures. While GMP observations at the company’s third-party plant are being addressed by the newly acquired owner Benta Group, Xspray still targets a second-half 2026 launch for both Dasynoc and XS003-nilotinib, with a new PDUFA date expected no later than August 2026.

The most recent analyst rating on (SE:XSPRAY) stock is a Hold with a SEK27.00 price target. To see the full list of analyst forecasts on Xspray Pharma AB stock, see the SE:XSPRAY Stock Forecast page.

More about Xspray Pharma AB

Xspray Pharma AB is a Swedish pharmaceutical company developing improved versions of marketed protein kinase inhibitors for cancer treatment using its patented HyNap technology. Its lead candidates include Dasynoc, an amorphous form of dasatinib, and XS003-nilotinib, with a portfolio also featuring optimized versions of axitinib and cabozantinib, targeting the large and high-priced oncology market segment.

Average Trading Volume: 48,978

Technical Sentiment Signal: Sell

Current Market Cap: SEK1.09B

Learn more about XSPRAY stock on TipRanks’ Stock Analysis page.