Company Announcement / Press release Archives

Xspray Pharma invites to a conference call following receipt of CRL for Dasynoc

Xspray Pharma invites investors, analysts and media to a conference call following the company’s receipt of a Complete Response Letter, CRL, from the U.S. Food and Drug Administration, FDA, in relation to the company’s New Drug Application, NDA for Dasynoc. The receipt of the CRL was announced in a press release earlier today, 19 August […]

Xspray Pharma receives Complete Response Letter (CRL) from FDA for Dasynoc

The FDA’s Complete Response Letter relates to the previously communicated observations at NerPharMa, concerning outstanding GMP (Good Manufacturing Practice) observations, as well as a request for additional commercial scale consecutive batch data following already implemented corrective actions. Importantly, the FDA has not raised questions regarding Dasynoc's clinical data, bioequivalence or stability. Furthermore, the risk of […]

Xspray Pharma Interim Report Second Quarter 2026

April-June 2026, Group Net sales amounted to SEK 0 thousand (0) Earnings before tax amounted to SEK -39,794 thousand (-44,885) Earnings per share before dilution amounted to SEK -0.87 (-1.21) Cash flow from operating activities amounted to SEK -36,946 thousand (-44,111) Cash flow from investing activities amounted to SEK -10,307 thousand (-6,132) Amounts in parentheses […]

Xspray Pharma provides regulatory update on its US product candidates Nilopki® and Dasynoc® and notes continued progress with its third-party manufacturer NerPharMa

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) provides an update on the FDA review of its two US new drug applications. For Nilopki®, Xspray has defined an approach to address the items raised in the Complete Response Letter (CRL) of 4 June 2026 and has requested a Type A meeting with the FDA, expected within […]

Xspray Pharma to host a conference call regarding Nilopki™

Xspray Pharma invites investors, analysts and media to a conference call (in English) on Monday, June 8, 2026, at 3:00 PM CET due to the news communicated on the night of today June 5, regarding the CRL received from the FDA for Nilopki™. The conference call will be hosted by CEO Blake Leitch and CSO […]

Xspray Pharma Receives CRL from U.S. FDA for Nilopki™

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a pharmaceutical company leveraging its proprietary HyNap™ technology platform to develop improved versions of marketed protein kinase inhibitors (PKIs) for cancer treatment, has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Nilopki™, an optimized formulation […]

Xspray Pharma employees fully participate in market priced long term incentive programs, signaling strong confidence ahead

Xspray Pharma’s two newly implemented long-term incentive programs, LTIP 2025/2028 and LTIP 2026/2029, have reached full participation from the employees to whom they were offered. Participating employees paid a calculated market price, and every warrant offered was taken up in full. The programs mature from May 2028 onwards with subscription prices of SEK 49.30 and […]

Bulletin from the annual general meeting of Xspray Pharma AB (publ) 12 May 2026

The following resolutions were passed at the annual general meeting (the “AGM”) of Xspray Pharma AB (publ) (“Xspray”) on 12 May 2026. Adoption of income statement and balance sheet for the financial year 2025 and discharge from liabilityThe AGM resolved to adopt the income statement and the consolidated income statement for the financial year 2025 […]

New number of shares and votes in Xspray Pharma after new share issue April 2026

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today announces that the number of shares and votes in Xspray Pharma AB has changed. New shares have been issued as a result of the rights issue and over-allotment issue announced on March 24, 2026. On March 26, 2026, the Board of Directors also decided to increase the over-allotment […]

Interim Report First Quarter 2026

January–March 2026, Group Net sales amounted to SEK 0 thousand (0) Earnings before tax amounted to SEK -35,380 thousand (-42,321) Earnings per share before dilution amounted to SEK -0.85 (-1.14) Cash flow from operating activities amounted to SEK -30,676 thousand (-66,329) Cash flow from investing activities amounted to SEK -1,067 thousand (-14,701) Amounts in parentheses […]