Company Announcement / Press release Archives - Page 15 of 18

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 […]

Xspray aims for up-listing first half of 2020

STOCKHOLM – September 10, 2019. Xspray Pharma (Nasdaq First North Growth Market: XSPRAY) revises the schedule for its planned list change from Nasdaq First North Growth Market to Nasdaq Stockholm, with the goal to complete the up-listing in the first half of 2020. On October 25, 2018, Xspray announced the Board of directors’ decision to apply for […]

Xspray Pharma publishes Interim Report Q2, January – June 2019

August 29, 2019 ”We have previously shown that it is possible to manufacture small pilot quantities of amorphous material for clinical studies but now we have shown that the process works at commercial scale. We have ”cracked the code”, so to speak, and have taken a great step toward a finished product.” Per Andersson, CEO […]

Successful production start for HyNap-Dasa in Xspray’s unique full-scale production line

STOCKHOLM – June 27, 2019. Xspray Pharma (Nasdaq First North: XSPRAY) today announced that the first of two full-scale production lines, producing the company's amorphous formulation on a commercial scale, is now installed and tested in Milan, Italy. This means that the development of the company's first product candidate HyNap-Dasa, an amorphous version of Sprycel® (dasatinib), is proceeding […]

Xspray granted additional product patents in the United States for HyNap-Sora and HyNap-Nilo

STOCKHOLM – June 11, 2019. Xspray Pharma (Nasdaq First North: XSPRAY) announces that the United States Patent and Trademark Office (USPTO) has granted Xspray two new patents in the United States for its product candidates HyNap-Sora and HyNap-Nilo. The new patents are Xspray’s sixth and seventh product patents, respectively, in the United States, which is Xspray’s main market. […]