Company Announcement / Press release Archives - Page 10 of 19

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 […]

Notice of annual general meeting of Xspray Pharma AB (publ)

The shareholders of Xspray Pharma AB (publ), Reg. No. 556649-3671, are summoned to the annual general meeting on Thursday 20 May 2021. Due to the extraordinary situation resulting from the covid-19 pandemic, Xspray Pharma’s annual general meeting will be carried out through advance voting (postal voting) pursuant to temporary legislation. No meeting with the possibility […]

Xspray Pharma announces update of its improved version of dasatinib

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) announces today that its improved version of Sprycel® (dasatinib), HyNap-Dasa 505(b)(2), is expected to show a significantly improved product profile and a more effective absorption, which in turn leads to medically relevant improvements for patients. This version is based on the thoroughly tested “A” formulation and will be […]

Xspray Pharma announces the results of two bioequivalence studies with adjusted tablet formulation of HyNap-Dasa (ANDA)

Xspray Pharma AB (publ), (Nasdaq Stockholm: XSPRAY) announces today the preliminary results of two bioequivalence study on fasting and non-fasting healthy volunteers using a slightly adjusted tablet formulation of the generic product candidate HyNap-Dasa “B”. In the study on non-fasting subjects, bioequivalence with Sprycel was achieved. In the study on fasting subject’s lower absorption was […]