Company Announcement / Press release Archives - Page 12 of 17

Xspray strengthens the value of the product portfolio with patent protection for tablet of dasatinib propylene glycol solvate

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) announces today that the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) regarding its patent application for tablets containing dasatinib propylene glycol solvate (dasatinib PG). When issued this patent will significantly strengthen Xspray's IP rights and means that any possible future […]

Xspray announces preliminary results from the first study for its lead product candidate HyNap-Dasa

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) today announces preliminary data from the first out of two bioequivalence studies in healthy volunteers with its lead product candidate HyNap-Dasa. The primary aim was to demonstrate bioequivalence for HyNap-Dasa compared to the reference product Sprycel. The first study did not fulfil statistical bioequivalence requirements due to high […]

Xspray enters manufacturing collaboration in Malta

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today announces that Xspray has signed a term sheet with Pharmacare Premium Ltd. for a new manufacturing facility in Malta based on its patented technology platform. The new production lines will be placed within Pharmacare Premium’s existing facility. Apart from increasing Xspray’s manufacturing capacity for amorphous protein kinase inhibitors […]

Xspray Pharma publishes Interim Report Q2, January – June 2020

"We are in the final development phase of our first protein kinase inhibitor (PKI) project, HyNap-Dasa. HyNap- Dasa has shown good results in previous clinical studies and we are looking forward to seeing positive result this time as well. We have ahead of us an exciting and eventful second half of the year, with the […]

First study group has been dosed in Xspray Pharma’s ongoing pivotal registration studies with HyNap-Dasa

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today announces that all healthy volunteers now have been dosed in the first of the two studies to demonstrate that HyNap-Dasa is bioequivalent to the original drug Sprycel® (dasatinib). The first group is conducted under fasting conditions and the second group is conducted under fed conditions. The two bioequivalence […]

Xspray – Virtual Capital Markets Day today at 14.00 CET

Xspray Pharma (Nasdaq Stockholm: XSPRAY) will host a virtual Capital Markets Day today, June 25, at 14.00-15:30 CET. Theme of the day will be how Xspray's product candidate HyNap-Dasa can pave the way for a number of followers based on the company's technology platform. Program (approximate time): 14:00 Xspray’s operations and remaining development steps for HyNap-Dasa– […]

Invitation to virtual Capital Markets Day with Xspray on June 25 at 14.00-15.30 CET

Xspray Pharma (Nasdaq Stockholm: XSPRAY) will host a virtual Capital Market Day on June 25 at 14.00-15.30 CET. Theme of the day will be how Xspray's product candidate HyNap-Dasa can pave the way for a number of followers based on the company's technology platform. The Capital Markets Day can be seen via Xspray's website: www.xspraypharma.com. […]

Xspray Pharma initiates pivotal registration studies with HyNap-Dasa for the market approval application in the United States

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today announces the start of the pivotal clinical bioequivalence studies with HyNap-Dasa. The studies are conducted on healthy volunteers with the objective to demonstrate that HyNap-Dasa is bioequivalent to the original drug Sprycel® (dasatinib). The bioequivalence studies consist of two studies, where the first one, starting today, is conducted […]

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 14 May 2020 in Stockholm. Adoption of income statement and balance sheet for the financial year 2019 and discharge from liability The AGM resolved to adopt the income statement for the financial year 2019 as well […]

Xspray Pharma publishes Interim report Q1, January – March 2020

“This year is an important year for Xspray. I expect that the amorphous material provided by our unique production facility will provide positive clinical data, which is a prerequisite for us to apply for market approval for HyNap-Dasa in the U.S. This means that we together with a partner who either buys or licenses the […]