Company Announcement / Press release Archives

Xspray’s rights issue oversubscribed – over-allotment issue increased and fully utilized

THIS PRESS RELEASE MAY NOT BE MADE PUBLIC, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, BELARUS, CANADA, HONG KONG, JAPAN, NEW ZEELAND, RUSSIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, OR ANY OTHER JURISDICTION IN WHICH SUCH ACTIONS, WHOLLY OR IN PART, WOULD BE UNLAWFUL OR DEMAND ADDITIONAL […]

First day of trading in subscription rights and BTAs moved to August 27

Xspray publishes disclosure document regarding rights issue

Xspray receives additional subscription undertakings of SEK 20 million in the ongoing rights issue

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction […]

Interim Report Second Quarter 2025

April–June 2025, Group Net sales amounted to SEK 0 thousand (0) Earnings before tax amounted to SEK -44,885 thousand (-53,620) Earnings per share before dilution amounted to SEK -2.35 (-1.64) Cash flow from operating activities amounted to SEK -44,111 thousand (-64,181) Cash flow from investing activities amounted to SEK -6,132 thousand (-8,738) January–June 2025, Group […]

Xspray resolves on a rights issue of approximately SEK 130 million with an over-allotment issue and carries out debt refinancing

Xspray Pharma signs license agreement with Handa Therapeutics – to receive up to double-digit royalty on Handa’s net proceeds

Xspray Pharma (“Xspray”) has entered into a license agreement with Handa Therapeutics (“Handa”) granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa’s […]

XSpray Pharma achieves significant milestone – demonstrating bioequivalence with absorption advantages compared to Tasigna

Xspray Pharma has now completed the population pharmacokinetic (PopPK) modeling that constitutes key regulatory documentation ahead of submitting a New Drug Application (NDA) for the product candidate XS003. The analysis confirms bioequivalence with the reference drug Tasigna®, at less than half the dose – a strong indication marking a potential paradigm shift in the treatment […]

Xspray Pharma Passes FDA Pre-Approval Inspection – Key Regulatory Milestone Achieved for Dasynoc

Xspray Pharma AB (publ) today announces that the U.S. Food and Drug Administration (FDA) has conducted a successful Pre-Approval Inspection (PAI) of the company’s manufacturing lines, located at a contract manufacturing partner. The inspection confirms that production of the product candidate Dasynoc is fully compliant with current Good Manufacturing Practice (cGMP) standards, marking a key […]