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Xspray Pharma AB (publ) (6XP.SG)

2.9600

-0.1900

(-6.03%)

At close: January 10 at 8:11:16 AM GMT+1

Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission

STOCKHOLM, 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 Q4 2024, incorporating feedback from the Complete Response Letter (CRL) issued by FDA in July 2024. If the FDA sets

Business Wire 3 months ago

XSPRAY.ST
Scientific Article in Leading Journal Endorses Xspray Pharma's HyNap Technology

STOCKHOLM, September 06, 2024--A new scientific article, published in the US journal Clinical Pharmacology in Drug Development, shows how Xspray Pharma's HyNap™ technology improves the bioavailability and reduces variability of two important tyrosine kinase inhibitors (TKIs), Dasynoc™ (XS004, dasatinib) and XS005 (sorafenib). Reduced variability generally leads to better safety and can potentially increase treatment effectiveness for patients, ensuring prescribers that their seriously ill patien

Business Wire 4 months ago

XSPRAY.ST
Xspray Pharma’s XS003 Study Shows Matching Bioavailability to Tasigna at More than a 50% Lower Dose

STOCKHOLM, July 09, 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, announced today new clinical data from its XS003 registration study program. XS003 is an amorphous, non-crystalline formulation of nilotinib designed to overcome significant limitations of currently marketed crystalline formulations. In the announced study, XS003 demonstrates ma

Business Wire 6 months ago

XSPRAY.ST
Xspray 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

STOCKHOLM, May 23, 2024--Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a Swedish pharmaceutical company which uses its innovative Hynap technology to develop 505(b)(2) improved versions of marketed drugs for the treatment of cancer announced today the online publication of its abstract titled "Frequency of Comedication of Proton Pump Inhibitors with Crystalline Dasatinib in Chronic Myeloid Leukemia and Effects on TKI-Bioavailability" for presentation at the upcoming American Society of Cli

Business Wire 7 months ago

XSPRAY.ST
FDA Accepts Xspray Pharma’s NDA-resubmission for Dasynoc® – PDUFA Date set to 31 July 2024

STOCKHOLM, February 12, 2024--Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY): The U.S. Food and Drug Administration (FDA) has accepted the resubmission of Xspray Pharma’s New Drug Application (NDA) for Dasynoc®, following a Complete Response Letter (CRL) where additional information was requested. The FDA has now assigned a Prescription Drug User Fee Act (PDUFA) date to 31st of July, 2024. This is the FDA’s deadline for completing the approval process, marking a significant milestone for Das

Business Wire 10 months ago

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Performance Overview

Return	6XP.SG	OMX Stockholm 30 Index
YTD	-16.62%	+1.64%
1-Year	-12.94%	+7.63%
3-Year	-51.87%	+5.11%

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Xspray Pharma AB (publ) (6XP.SG)

Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission

Scientific Article in Leading Journal Endorses Xspray Pharma's HyNap Technology

Xspray Pharma’s XS003 Study Shows Matching Bioavailability to Tasigna at More than a 50% Lower Dose

Xspray 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

FDA Accepts Xspray Pharma’s NDA-resubmission for Dasynoc® – PDUFA Date set to 31 July 2024

Performance Overview