Stuttgart - Delayed Quote ? EUR Xspray Pharma AB (publ) (6XP.SG) Follow Compare 5.38 +0.56 (+11.62%) At close: October 21 at 4:39 PM GMT+2 All News Press Releases SEC Filings All SEC Filings Corporate Changes & Voting Matters Periodic Financial Reports Proxy Statements Tender Offer/Acquisition Reports Offering Registrations 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 ? last month 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 ? last month 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 ? 3 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 ? 4 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 ? 8 months ago XSPRAY-TO6.ST XSPRAY.ST Xspray Pharma’s XS003 Achieves Superior Bioavailability Milestone, Matching TASIGNA? at Reduced Dosage STOCKHOLM, November 21, 2023--Xspray Pharma AB (Stockholm/Nasdaq: XSPRAY) a biotechnology company developing improved PKIs for cancer treatment, through its proprietary HyNap? technology, today announced that XS003, its amorphous, non-crystalline formulation of nilotinib, has demonstrated bioavailability within the 80-125% range to TASIGNA? following oral administration with significantly lower dose. This is the second of three announced amorphous PKIs under development by Xspray using the HyNap Business Wire ? 10 months ago XSPRAY-TO5.ST XSPRAY-TO6.ST XSPRAY.ST DASYNOC? Uptake into the Blood Remains Consistent When Taken with Omeprazole, Whereas SPRYCEL? Uptake is Significantly More Impaired than Previously Understood STOCKHOLM, November 08, 2023--Xspray Pharma AB (Stockholm/Nasdaq: XSPRAY) a biotechnology company developing improved TKIs for cancer treatment, through its proprietary HyNap? technology, today announced the results from drug interaction studies demonstrating that DASYNOC’s (DASYNOC CO-PPI Study) uptake into blood following oral dosing is not altered by the concomitant administration of omeprazole, a commonly prescribed PPI, while a significant reduction in the uptake of SPRYCEL (SPRYCEL CO-PPI Business Wire ? 11 months ago XSPRAY-TO5.ST XSPRAY-TO6.ST XSPRAY.ST Performance Overview Trailing total returns as of 10/21/2024, which may include dividends or other distributions. Benchmark is OMX Stockholm 30 Index Return 6XP.SG OMX Stockholm 30 Index YTD +61.56% +7.42% 1-Year +82.99% +24.00% 3-Year -8.74% +10.74%
