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svXspray Pharma re-submits its FDA application for Dasynoc
Xspray Pharma AB (publ) has re-submitted its application for market approval for Dasynoc® to the U.S. Food and Drug Administration (FDA). Dasynoc® is the company's lead product candidate – an amorphous dasatinib for the treatment of leukemia. The resubmission includes the additional information requested by the FDA. A new PDUFA-date is expected to be set […]
Read moreXspray Pharma appoints Blake Leitch as CEO – Per Andersson continues as Chief Scientific Officer (CSO)
The Board of Directors of Xspray Pharma has today appointed Blake Leitch as CEO of Xspray Pharma, effective no later than June 1, 2026. He brings over 20 years of international experience of marketing and sales in the pharma industry. He succeeds Per Andersson who will transition to a key role as Chief Scientific Officer […]
Read moreInterim Report Fourth Quarter 2025
October–December 2025, Group Net sales amounted to SEK 0 thousand (0) Earnings before tax amounted to SEK -37,009 thousand (-82,002) Earnings per share before dilution amounted to SEK -0.89 (-2.36) Cash flow from operating activities amounted to SEK -41,370 thousand (-61,601) Cash flow from investing activities amounted to SEK -1,488 thousand (-19,202) January–December 2025, Group […]
Read moreInterim Report Third Quarter 2025
July–September 2025, Group Net sales amounted to SEK 0 thousand (0) Earnings before tax amounted to SEK -47,332 thousand (-82,272) Earnings per share before dilution amounted to SEK -1.25 (-2.44) Cash flow from operating activities amounted to SEK -41,354 thousand (-41,275) Cash flow from investing activities amounted to SEK -6,865 thousand (-9,053) January–September 2025, Group […]
Read moreXspray Pharma: FDA accepts New Drug Application for XS003 (nilotinib) for the treatment of CML – PDUFA date set for June 18, 2026
Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) announces that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for XS003 (nilotinib) for review under the 505(b)(2) regulatory pathway. The FDA has set a PDUFA date to June 18, 2026, which is the date by when the agency is expected […]
Read moreXspray Pharma’s Nomination Committee for the Annual General Meeting 2026
Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) publishes the Nomination Committee’s composition for the Annual General Meeting, May 12, 2026. The Nomination Committee, which has been appointed in accordance with the principles adopted by the Annual General Meeting on 13 May 2025, consists of: Thomas Eldered, appointed by Flerie AB, Chairman of the Nomination Committee Johan […]
Read moreXspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval
• FDA has issued a Complete Response Letter (CRL) regarding Xspray Pharma’s New Drug Application (NDA) for Dasynoc™, referring to GMP (Good Manufacturing Practice) observations at a contract manufacturer. These observations do not concern the Xspray´s production line. • Xspray discussed the product information for Dasynoc with the FDA up to the PDUFA date. The […]
Read moreNew number of shares and votes in Xspray Pharma after new share issue
Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today announces that the number of shares and votes in Xspray Pharma AB has changed. New shares have been issued as a result of the rights issue and over-allotment issue announced on August 15, 2025. On September 11, 2025, the Board of Directors also decided to increase the over-allotment […]
Read moreXspray’s rights issue oversubscribed – over-allotment issue increased and fully utilized
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Read moreFirst day of trading in subscription rights and BTAs moved to August 27
THIS PRESS RELEASE MAY NOT BE MADE PUBLIC, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, BELARUS, CANADA, HONG KONG, JAPAN, NEW ZEELAND, RUSSIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, OR ANY OTHER JURISDICTION IN WHICH SUCH ACTIONS, WHOLLY OR IN PART, WOULD BE UNLAWFUL OR DEMAND ADDITIONAL […]
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