Company Announcement / Press release Archives - Page 11 of 18

Xspray Pharmas study with modified formulation of HyNap-Dasa has now started

Xspray Pharma (Nasdaq Stockholm: XSPRAY) announces today that the new bioequivalence studies with a slightly modified formulation of HyNap-Dasa has started. The studies are conducted on healthy volunteers with the objective to demonstrate that HyNap-Dasa is bioequivalent to the original drug Sprycel® (dasatinib) in order to then be able to submit an application for market […]

Xspray Pharma announces results from additional bioequivalence study and provides update regarding upcoming regulatory applications for ANDA and 505(b)(2)

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) today announces results from the extra bioequivalence study in fasting healthy volunteers conducted with the Company's leading product candidate HyNap-Dasa. The results are in line with previous bioequivalence studies, but the results show that the study design is robust. Xspray Pharma will already next week start the previously […]

Xspray Pharma reports positive results from a study with dasatinib during omeprazole treatment

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) announces today that it has received positive preliminary results from a bioavailability study in healthy volunteers with an improved HyNap-Dasa version of the reference drug Sprycel™, demonstrating that absorption of HyNap-Dasa is not dependent on the gastric pH level. HyNap-Dasa is being developed both as a generic and […]

Xspray Pharma’s HyNap-Nilo receives FDA Orphan Drug Designation for the treatment of Chronic Myeloid Leukemia

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its product candidate, HyNap-Nilo, for the treatment of chronic myeloid leukemia (CML). HyNap-Nilo is under development as an improved version of TasignaTM (nilotinib), a leading drug for CML. The FDA’s Orphan Drug […]

Xspray Pharma moves up to Nasdaq Stockholm’s Mid Cap-segment

Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announces today that the company’s share will be moved to Nasdaq Stockholms Mid Cap segment on 4 January 2021 The move from the Small Cap is a result of Nasdaq’s annual review of the average market values within the Nordic market segments. The Mid Cap segment includes companies with […]

Xspray Pharma has decided to await the result of two ongoing clinical studies before submitting its ANDA application

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) today announces that the last subject in the additional bioequivalence (BE) study has been dosed faster than expected and that it has also obtained preliminary positive data from a study on improved HyNap-Dasa. Xspray Pharma has therefore made the strategic decision to submit its ANDA application for HyNap-Dasa […]

Xspray Pharma publishes Interim Report Q3, January – September 2020

”Xspray Pharma is in an eventful phase with several crucial milestones within reach. After completing bioequivalence studies, intensive work is being done on the preparations for the Company's first ANDA application and finding the right partner for HyNap-Dasa”. Per Andersson, CEO Xspray Pharma AB (publ) Significant events during the third quarter, 2020 In August, a […]

Number of shares and votes in Xspray

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) announces today that the number of shares and votes in Xspray Pharma has changed as a result of shares being registered due to the directed share issue which was carried out in October 2020. Through the direct share issue, carried out in October 2020, the number of outstanding shares […]

Xspray Pharma’s Nomination Committee for the Annual General Meeting 2021

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) publishes the Nomination Committee’s composition for the Annual General Meeting in 2021. The Nomination Committee, which has been appointed in accordance with the principles adopted by the Annual General Meeting on 14 May 2020, consists of: Gillis Cullin, appointed by Östersjöstiftelsen Johan Gyllenswärd, appointed by Ribbskottet AB Caroline Sjösten, […]

Xspray Pharma Has Carried Out a Directed Share Issue Raising Gross Proceeds of Approximately SEK 265 million

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. Xspray Pharma AB (publ) (“Xspray” or the “Company”) has, based on the authorisation […]