Company Announcement / Press release Archives - Page 7 of 16

Xspray Pharma submits application for market approval to FDA for its product candidate Dasynoc

Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announces today that the application for US market approval of its first product candidate Dasynoc (dasatinib) has been submitted, in accordance with plans, to the Food and Drug Administration (FDA) under the 505(b)(2) NDA procedure, which is the registration path that applies to improved drugs. The application consists of […]

Xspray Pharma strengthens the organization with IR and Communications function

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) today announces that the company is strengthening its organization by creating an Investor Relations and Communications function. Christina Malmberg Hägerstrand has been appointed Vice President and Head of Investor Relations and Communications, she joins Xspray Pharma in January 2022. “With the development of Xspray Pharma and the initial […]

Xspray Pharma completes a directed new share issue to Flerie Invest, raising approximately SEK 100 million

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) today announces that the board of directors has resolved on a directed new share issue of 1,612,904 shares at a price of SEK 62 per share, corresponding to in total approximately SEK 100 million. The board of directors of Xspray Pharma has, based on the authorisation granted by […]

Xspray Pharma publishes interim report Q3, January – September 2021

"Since the company's start, the business's focus and communication has been on generic and improved versions of PKIs. Going forward we have, after the end of the reporting period, decided to focus entirely on improved PKIs. In recent years, the value of generics in our models has gradually decreased, while the value of improved drugs […]

Xspray Pharma brings forward publication of the Q3 interim report

Xspray Pharma (publ) announces that the company is bringing forward the publication of its interim report for January-September, 2021, to Tuesday, October 26, 2021, instead of on Friday, November 4, 2021, as previously announced. The work with the quarterly accounts has proceeded faster than expected, therefore the Q3 interim report will be released earlier than […]

Xspray Pharma’s Nomination Committee for the Annual General Meeting 2022

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) publishes the Nomination Committee’s composition for the Annual General Meeting in 2022. The Nomination Committee, which has been appointed in accordance with the principles adopted by the Annual General Meeting on 20 May 2021, consists of: Gillis Cullin, appointed by Östersjöstiftelsen Anders Bladh, appointed by Ribbskottet AB Caroline Sjösten, […]

Xspray Pharma has obtained results from bioequivalence studies with HyNap-Dasa ANDA and decides to focus on its improved dasatinib product, Dasynoc™

Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announces today that the Company has obtained results from the bioequivalence studies with the generic product candidate HyNap-Dasa ANDA C. The results show that the bioequivalence with the reference product Sprycel® was achieved in fed but not in fasting subjects due to the high variability of Sprycel®. The Company […]

All participants in Xspray Pharma studies have received their dose of generic version of dasatinib, HyNap-Dasa ANDA

Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announces today that all participants have received their dose in the two bioequivalence studies with the generic product candidate of dasatinib, HyNap-Dasa ANDA. The bioequivalence studies were conducted on fed and fasting healthy volunteers. The aim of the studies is to achieve bioequivalence for HyNap-Dasa ANDA compared with the […]

Xspray Pharma has initiated studies with generic version of dasatinib, HyNap-Dasa ANDA

Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announced today that the pivotal bioequivalence studies have been initiated with the modified tablet formulation of the generic product candidate with dasatinib, HyNap-Dasa ANDA "C". The bioequivalence studies are being conducted in fed and fasting healthy volunteers. The purpose of the studies is to achieve bioequivalence for HyNap-Dasa ANDA […]

Xspray Pharma publishes interim report Q2 , January – June 2021

"We have now shown that our unique technology platform makes it possible to develop amorphous versions of protein kinase inhibitors, or PKIs. With HyNap-Dasa 505(b)(2) and previous studies, we have demonstrated that we can scale up the process and modify formulations to change the uptake of the drug and achieve bioequivalence. This will be of […]