Company Announcement / Press release Archives

XSpray Pharma achieves significant milestone – demonstrating bioequivalence with absorption advantages compared to Tasigna

Xspray Pharma has now completed the population pharmacokinetic (PopPK) modeling that constitutes key regulatory documentation ahead of submitting a New Drug Application (NDA) for the product candidate XS003. The analysis confirms bioequivalence with the reference drug Tasigna®, at less than half the dose – a strong indication marking a potential paradigm shift in the treatment […]

Xspray Pharma Passes FDA Pre-Approval Inspection – Key Regulatory Milestone Achieved for Dasynoc

Xspray Pharma AB (publ) today announces that the U.S. Food and Drug Administration (FDA) has conducted a successful Pre-Approval Inspection (PAI) of the company’s manufacturing lines, located at a contract manufacturing partner. The inspection confirms that production of the product candidate Dasynoc is fully compliant with current Good Manufacturing Practice (cGMP) standards, marking a key […]

FDA sets PDUFA-date for Xspray Pharma’s re-submitted application for Dasynoc®

The U.S. Food and Drug Administration (FDA) has acknowledged receipt of Xspray Pharma's re-submitted NDA (New Drug Application) for Dasynoc®. The re-submission is based on a CRL (Complete Response Letter) received from the FDA in July 2024 where additional information was requested. The FDA has now set the PDUFA date to 7 October 2025, which […]

Bulletin from the annual general meeting of Xspray Pharma AB (publ)

The following resolutions were passed at the annual general meeting (the “AGM”) of Xspray Pharma AB (publ) (“Xspray”) on 13 May 2025. Adoption of income statement and balance sheet for the financial year 2024 and discharge from liabilityThe AGM resolved to adopt the income statement and the consolidated income statement for the financial year 2024 […]

Interim Report First Quarter 2025

January – March 2025, Group• Net sales amounted to SEK 0 thousand (0)• Earnings before tax amounted to SEK -42,321 thousand (-67,781)• Earnings per share before dilution amounted to SEK -1.14 (-2.17)• Cash flow from operating activities amounted to SEK -66,329 thousand (-55,311)• Cash flow from investing activities amounted to SEK -14,701 thousand (-5,149) Amounts […]

Notice of annual general meeting of Xspray Pharma AB (publ)

The shareholders of Xspray Pharma AB (publ), Reg. No. 556649-3671, (”Xspray Pharma”) are summoned to the annual general meeting on Tuesday 13 May 2025 at 10.00 CEST at Advokatfirman Vinge’s office on Smålandsgatan 20 in Stockholm. Registration starts at 9.30 CEST. The shareholders may exercise their voting rights at the annual general meeting by attending […]

Xspray Pharma re-submits its FDA application

Xspray Pharma AB (publ) has re-submitted its application for market approval for Dasynoc®, the company's lead product candidate, an amorphous dasatinib for the treatment of leukemia. The application procedure thus runs according to the most recently communicated plan. Within 2-4 weeks, the FDA is expected to announce a new PDUFA date, i.e. the date they […]

Xspray Pharma AB publishes its Annual Report for 2024

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today publishes its Annual Report for the financial year 2024. An extract from the CEO-letter from Per Andersson, CEO of Xspray Pharma: “In 2024, we finalized the foundation for Xspray Pharma’s transformation from an innovative, research-driven company into a commercial drug company. We have addressed regulatory challenges, conducted market […]

Interim Report Fourth Quarter 2024

October–December 2024, Group Net sales amounted to SEK 0 thousand (0) Loss before tax amounted to SEK -82,002 thousand (-54,513) Earnings per share before dilution amounted to SEK -2.36 (-1.85) Cash flow from operating activities amounted to SEK -61,601 thousand (-32,626) Cash flow from investing activities amounted to SEK -19,202 thousand (-20,729) Amounts in parentheses […]

Xspray Pharma reports strong interim data for product candidate XS003 – confirms plan to apply for market approval in H1 2025

Xspray Pharma AB (publ) today presents interim data from a food interaction study with the nilotinib product candidate (XS003). The results confirm the benefits of the company's patented HyNap™ technology platform and its ability to deliver significant benefits for patients compared to existing PKI drugs. Key findings from interim data: Food interaction and safety: Xspray's […]