Company Announcement / Press release Archives - Page 9 of 18

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 […]

Xspray Pharma announces achievement of bioequivalence compared with reference product from bioequivalence study with HyNap-Dasa 505(b)(2)

Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announced today that positive results have been obtained from the pivotal bioequivalence study with the company’s improved product dasatinib, known as HyNap-Dasa 505(b)(2). The study fulfilled the bioequivalence requirements compared with the reference product, Sprycel®. The results demonstrate that Xspray Pharma can reduce the dose strength by 30% but […]

All participants in Xspray Pharma’s study have received their dose of the improved version of dasatinib

Xspray Pharma (Nasdaq Stockholm: XSPRAY) announces today that all participants have received their dose of the company’s improved amorphous version of dasatinib for the bioequivalence study. The study is being conducted on fasting healthy volunteers with the objective to demonstrate that a lower dose strength of Xspray Pharma’s improved version of dasatinib will have the […]

Xspray Pharma’s two incentive programs are fully subscribed

Xspray Pharma (publ) has inaugurated two long term incentive programs, one for all employees and senior executives in the Group (LTIP 2021–2024), as well as one for the new Chairman of the Board (LTIP 2021–2026), through the issuance of warrants. LTIP 2021–2024 provides employees with the opportunity to subscribe for new shares in three years, […]

Xspray Pharma commences study with improved version of dasatinib

Xspray Pharma (Nasdaq Stockholm: XSPRAY) announced today that a bioequivalence study with the improved version of dasatinib has commenced. The objective of the study is to demonstrate that a lower dose strength of Xspray Pharma’s improved version of dasatinib is bioequivalent to a higher dose strength of the original drug Sprycel®. The study is being […]

Bulletin from the annual general meeting of Xspray Pharma AB (publ)

The following resolutions were passed at the annual general meeting (the “AGM”) of Xspray Pharma AB (publ) (“Xspray”) on 20 May 2021. Adoption of income statement and balance sheet for the financial year 2020 and discharge from liability The AGM resolved to adopt the income statement and the consolidated income statement for the financial year […]

Xspray Pharma publishes Interim Report Q1, January – March 2021

"We are working on a technology platform with potential for many PKI products. The results of the latest studies have set us back, but in a greater perspective it is an unwelcome but minor obstacle. What makes the product platform possible is the unique technology behind the HyNap formulations that can be scaled up. This […]