Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission
Stockholm, Sweden – September 19, 2024, Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a pharmaceutical company leveraging its proprietary HyNap™ technology to develop enhanced cancer therapies, today announced significant progress following a productive meeting with the U.S. Food and Drug Administration (FDA). The company plans to resubmit its New Drug Application (NDA) for Dasynoc in […]
Read moreInterim Report Second Quarter 2024
April–June 2024, Group Net sales amounted to SEK 0 thousand (0) Loss before tax amounted to SEK -53,620 thousand (-51,402) Earnings per share before dilution amounted to SEK -1.64 (-2.27) Cash flow from operating activities amounted to SEK -64,181 thousand (-56,503) Cash flow from investing activities amounted to SEK -8,738 thousand (-16,027) Amounts in parentheses […]
Read moreXspray Pharma Shares New Information on Dasynoc, a Novel CML Treatment in Development
Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Dasynoc, a novel treatment for chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL). The updated NDA was sent to the FDA on January 31, 2024. […]
Read moreXspray Pharma’s XS003 Study shows Matching Bioavailability to Tasigna at more than a 50% Lower Dose
Xspray Pharma provides an update on its second product candidate, XS003: New data shows matching bioavailability to Tasigna® at more than a 50% reduced dose. Stockholm, Sweden, July 9, 2024 – Xspray Pharma AB (Stockholm/Nasdaq: XSPRAY), a biotechnology company focused on developing improved protein kinase inhibitors (PKIs) for cancer treatment using its proprietary HyNap™ technology, […]
Read moreNew number of shares and votes in Xspray Pharma after TO6
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 and registered through the subscription of warrants series TO6 2023, which ended on May 2, 2024. In total, the number of outstanding shares and votes has increased by 2,508,723. […]
Read moreXspray to present data at ASCO highlighting frequent comedication of PPIs with TKIs in CML-patients and greater than expected negative effects on the bioavailability of crystalline dasatinib
i) 54% of TKI-treated CML-patients received a PPI. ii) 66% of concomitant prescribing was by a different healthcare provider. iii) Crystalline dasatinib Cmax and AUC24 reduced by 96% and 88% respectively. Stockholm, Sweden – Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a Swedish pharmaceutical company which uses its innovative Hynap technology to develop 505(b)(2) improved […]
Read moreBulletin from the annual general meeting of Xspray Pharma AB (publ), 21 May 2024
The following resolutions were passed at the annual general meeting (the “AGM”) of Xspray Pharma AB (publ) (“Xspray”) on 21 May 2024.Adoption of income statement and balance sheet for the financial year 2023 and discharge from liabilityThe AGM resolved to adopt the income statement and the consolidated income statement for the financial year 2023 as […]
Read moreXspray Pharma appoints Chief Operating Officer and changes the Management Team
Xspray Pharma has appointed Niklas Adenborg as the company’s CFO (Chief Financial Officer) and Linda Glimberg as the company’s COO (Chief Operating Officer), a newly established role. Both are already part of the Xspray Pharma team; Niklas Adenborg as Finance Director and Linda Glimberg as consulting Senior Vice President Legal. Both will be part of […]
Read moreInterim Report First Quarter 2024
January–March 2024, Group Net sales amounted to SEK 0 thousand (0) Loss before tax amounted to SEK -67,781 thousand (-34,827) Earnings per share before dilution amounted to SEK -2.17 (-1.54) Cash flow from operating activities amounted to SEK -55,311 thousand (-45,535) Cash flow from investing activities amounted to SEK -5,149 thousand (-14,650) Significant events during […]
Read moreXspray Pharma raises SEK 100.3 million through warrants TO6
Xspray Pharma today determined the outcome of exercised warrants of series TO6, issued in connection with the rights issue in June 2023 and for which the subscription period ended on May 2, 2024. In total, 2,508,723 series TO6-warrants were exercised to subscribe for the same amount of new shares. Xspray Pharma thereby receives proceeds of […]
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