Company Announcement / Press release Archives - Page 2 of 5

Additional product patent in the US for HyNap-Dasa

“This new patent on our most important market is yet another confirmation of our innovative development work. The formal clinical bioequivalence of the company’s primary product candidate HyNap-Dasa, which has been previously communicated, means that the patent further strengthens our position in negotiations with potential partners”, says Per Andersson, CEO of Xspray. Xspray strives to […]

Stability studies initiated with Xspray’s HyNap-Dasa tablets

On February 11, the stability studies of the final HyNap-Dasa tablets, manufactured on a commercial scale according to GMP standard (Good Manufacturing Practice) were initiated. The tablets will be evaluated after six months in stability studies according to regulatory requirements. ”The results of the studies now underway are an important part of our upcoming ANDA-application […]

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

Xspray Pharma’s CMO (Contract Manufacturing Organization) in the US, for the manufacturing of final tablets, has now produced the first batch of commercial-scale tablets according to GMP (Good Manufacturing Practice) standard. The manufactured batch is the first of three and is intended for regulatory stability studies which are scheduled to start early next year. According […]

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

A group of Swedish and international institutional investors, among others C WorldWide Asset Management, Fourth Swedish National Pension Fund, Swedbank Robur, TIN Fonder, Third Swedish National Pension Fund and Unionen have subscribed for shares in the Issue. The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate transaction structure at […]

Xspray Pharma contemplates a directed share issue

Description of the Issue The Issue is intended to be carried out with deviation from the shareholders’ preferential rights in accordance with the authorisation granted by the annual general meeting on 23 May 2019. The Issue is intended to be carried out through an accelerated building process (the “Bookbuilding”) which will commence immediately. Pricing and […]

Xspray receives FDA clearance of IND for 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 for review on September 30, 2019 by the US FDA. The application has now been given clearance by the FDA’s Division of Hematology Products (DHP). “We are very pleased that the […]

Xspray – Successful submission of IND application to FDA

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 to produce material for and perform clinical studies with the product candidate HyNap-Dasa.The Division of Hematology Products issued an IND Acknowledgment letter indicating that the […]

Xspray aims for up-listing first half of 2020

On October 25, 2018, Xspray announced the Board of directors’ decision to apply for listing of the company’s share on Nasdaq Stockholm’s main list, and that the up-listing was expected to take place within 12 months. Due to the resource-demanding work that is currently in progress, primarily production, clinical and business development, the Board has […]

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

Xspray Pharma’s production process at NerPharma in Milan, Italy, is developed for commercial production of drugs formulated with the company’s HyNap technology. The production facility is expected to receive official approval from the Italian pharmaceutical authority, AIFA, during the fourth quarter of 2019, which means that the material produced can be used in the company’s […]

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

“The new patents for HyNap-Sora and HyNap-Nilo make it significantly more difficult for our competitors to copy upcoming products from our unique platform technology. The patents are also essential for our ability to do good business deals and they strengthen our position in the US market,” says Per Andersson, CEO of Xspray. The new patents, […]