Company Announcement / Press release Archives - Page 9 of 17

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 […]

Xspray Pharma publishes its annual report for 2020

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) today announces that the company's annual report for the financial year 2020 has been published. “Our HyNap technology is the first of its kind in the world and allows multiple pathways to success. During the year, we established a unique supply chain and strengthened the patent position concurrently […]

Xspray Pharma aims to submit its improved version of dasatinib for market approval application in second half of 2021

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) announces today an update on the upcoming pivotal study with its improved version of Sprycel® (dasatinib), based on the company’s HyNap-Dasa formulation. The study has been initiated and the dosing for the bioequivalence study will start in the second quarter with the aim to submit an application for […]

Both groups in the two ongoing bioequivalence studies with Xspray Pharma’s product candidate HyNap-Dasa have been dosed

Xspray Pharma (publ) (Nasdaq Stockholm: XSPRAY) announces today that all healthy volunteers in the bioequivalence studies with an adjusted tablet formulation of the generic HyNap-Dasa ANDA have been dosed. The studies have been conducted in two groups of healthy volunteers under fasting and non-fasting conditions. The purpose of the studies is to achieve bioequivalence for […]

Xspray Pharma publishes Interim report Q4, January – December 2020

“Our business model is different from traditional drug development. Instead of developing a new drug candidate that will have to undergo Phase I, Phase II and Phase III studies, our technology platform produces amorphous PKI versions that need to demonstrate bioequivalence with already marketed drugs. Several of the marketed PKI:s are highly variable and have […]