Company Announcement / Press release Archives - Page 13 of 16

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

The shareholders of Xspray Pharma AB (publ), Reg. No. 556649-3671, are summoned to an extraordinary general meeting on Thursday 26 March 2020 at 16.00 CET at Advokatfirman Vinge’s office on Stureplan 8 in Stockholm. Registration starts at 15.30 CET. Right to attend the general meeting Shareholders who wish to attend the general meeting must: be […]

Three additional product patents in the US for HyNap-Dasa

STOCKHOLM – February 18, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the United States Patent and Trademark Office (USPTO) has granted Xspray three new US patent for HyNap-Dasa. The new patents, US10,561,643; US 10,561,644; and US10,561,645, are valid until January 2033. This means that Xspray now has seven product patents for […]

Additional product patent in the US for HyNap-Dasa

STOCKHOLM – February 12, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the United States Patent and Trademark Office (USPTO) has granted Xspray a new US patent for HyNap-Dasa. The new patent, US 10,555,937, covers the pharmaceutical composition of the company's primary product candidate, HyNap-Dasa. This is Xspray's fourth product patent in […]

Stability studies initiated with Xspray’s HyNap-Dasa tablets

STOCKHOLM – February 11, 2020. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the stability studies with the company’s commercially manufactured HyNap-Dasa tablets began today, February 11. The readout of the study results after six months will be a part of the company’s ANDA application (Abbreviated New Drug Application) for market approval in the US for […]

First batch of HyNap-Dasa tablets manufactured on commercial scale according to GMP

STOCKHOLM – December 19, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the first batch of HyNap-Dasa tablets has now been manufactured on commercial scale. The tablets are intended for the regulatory stability studies that are necessary for an ANDA application. The development of the company's first product candidate HyNap-Dasa, an amorphous […]

Xspray Pharma has carried out a directed share issue raising gross proceeds of approximately SEK 122 million

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL PURSUANT TO APPLICABLE RULES OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. Solna, 5 December 2019 Xspray Pharma AB (publ) (“Xspray” […]

Xspray Pharma contemplates a directed share issue

Xspray Pharma publishes Interim Report Q3, January – September 2019

November 14, 2019 ”It is with a high pace, dedication and broad expertise that Xspray's team continued to drive the development of our furthest progressed product candidate, HyNap-Dasa, towards our first ANDA application. HyNap-Dasa is an amorphous version of Sprycel® (dasatinib). The target of submitting an application to the US FDA during the summer of […]

Xspray receives FDA clearance of IND for HyNap-Dasa

2019.10.31 STOCKHOLM – October 31, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that the US Food and Drug Administration (FDA) has cleared the company's IND application for the product candidate HyNap-Dasa. Xspray Pharma's Investigational New Drug (IND) application, for permission to produce materials for and conduct clinical trials with the product candidate HyNap-Dasa, was accepted […]

Xspray – Successful submission of IND application to FDA

STOCKHOLM – October 4, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) announces that FDA has accepted the company’s submission of IND application for HyNap-Dasa. Xspray Pharma announces a successful submission of its Investigational New Drug (IND) application to the Food and Drug Administration (FDA), with acceptance date September 30th 2019, in order to obtain permission […]