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Est. tid*
2025-11-05 08:00 Kvartalsrapport 2025-Q3
2025-08-15 - Kvartalsrapport 2025-Q2
2025-05-14 - X-dag ordinarie utdelning XSPRAY 0.00 SEK
2025-05-13 - Årsstämma
2025-05-07 - Kvartalsrapport 2025-Q1
2025-02-12 - Bokslutskommuniké 2024
2024-11-06 - Kvartalsrapport 2024-Q3
2024-08-07 - Kvartalsrapport 2024-Q2
2024-05-22 - X-dag ordinarie utdelning XSPRAY 0.00 SEK
2024-05-21 - Årsstämma
2024-05-08 - Kvartalsrapport 2024-Q1
2024-02-14 - Bokslutskommuniké 2023
2023-11-08 - Kvartalsrapport 2023-Q3
2023-08-02 - Kvartalsrapport 2023-Q2
2023-05-25 - Extra Bolagsstämma 2023
2023-05-16 - Årsstämma
2023-05-05 - X-dag ordinarie utdelning XSPRAY 0.00 SEK
2023-05-04 - Kvartalsrapport 2023-Q1
2023-02-15 - Bokslutskommuniké 2022
2022-11-09 - Kvartalsrapport 2022-Q3
2022-08-05 - Kvartalsrapport 2022-Q2
2022-05-20 - X-dag ordinarie utdelning XSPRAY 0.00 SEK
2022-05-19 - Årsstämma
2022-05-06 - Kvartalsrapport 2022-Q1
2022-02-18 - Bokslutskommuniké 2021
2021-10-26 - Kvartalsrapport 2021-Q3
2021-08-06 - Kvartalsrapport 2021-Q2
2021-05-21 - X-dag ordinarie utdelning XSPRAY 0.00 SEK
2021-05-20 - Årsstämma
2021-05-06 - Kvartalsrapport 2021-Q1
2021-02-25 - Bokslutskommuniké 2020
2020-11-20 - Kvartalsrapport 2020-Q3
2020-07-31 - Kvartalsrapport 2020-Q2
2020-05-15 - X-dag ordinarie utdelning XSPRAY 0.00 SEK
2020-05-14 - Årsstämma
2020-05-14 - Kvartalsrapport 2020-Q1
2020-03-26 - Extra Bolagsstämma 2020
2020-02-28 - Bokslutskommuniké 2019
2019-11-14 - Kvartalsrapport 2019-Q3
2019-08-29 - Kvartalsrapport 2019-Q2
2019-05-23 - Årsstämma
2019-05-17 - X-dag ordinarie utdelning XSPRAY 0.00 SEK
2019-05-16 - Kvartalsrapport 2019-Q1
2019-02-14 - Bokslutskommuniké 2018
2018-11-28 - Kvartalsrapport 2018-Q3
2018-08-24 - Kvartalsrapport 2018-Q2
2018-05-16 - X-dag ordinarie utdelning XSPRAY 0.00 SEK
2018-05-14 - Årsstämma
2018-05-14 - Kvartalsrapport 2018-Q1
2018-02-20 - Extra Bolagsstämma 2017
2018-02-19 - Bokslutskommuniké 2017
2017-11-22 - Kvartalsrapport 2017-Q3

Beskrivning

LandSverige
ListaSmall Cap Stockholm
SektorHälsovård
IndustriBioteknik
Xspray Pharma är ett läkemedelsbolag med flera produktkandidater i klinisk utveckling som använder den patenterade HyNap-tekniken för att skapa förbättrade versioner av marknadsförda proteinkinashämmare. Läkemedelskandidaten Dasynoc® är en amorf form av dasatinib och genomgår en FDA-granskning för marknadsgodkännande. Xspray Pharma produktportfölj inkluderar även XS003-nilotinib, XS008-axitinib och XS025-cabozantinib.
2025-04-08 07:40:00

Xspray Pharma AB (publ) has re-submitted its application for market approval for Dasynoc®, the company's lead product candidate, an amorphous dasatinib for the treatment of leukemia. The application procedure thus runs according to the most recently communicated plan. Within 2-4 weeks, the FDA is expected to announce a new PDUFA date, i.e. the date they intend to decide on the application.

Xspray Pharma has submitted its response to the CRL (Complete Response Letter) that the company received from the FDA in July 2024. The CRL addressed the company's NDA application for market approval in the US of the product candidate Dasynoc, an amorphous dasatinib drug for the treatment of CML (chronic myeloid leukemia) and ALL (acute lymphoblastic leukemia). The response will now be reviewed by the FDA, which can apply two different processing times – two or six months from the re-submission date.

“Manufacturing and quality review of new tablet batches, which were required to address the FDA’s questions, have gone according to plan at Xspray’s US contract manufacturer, and live up to all the set quality requirements,” says Per Andersson, CEO of Xspray Pharma. “We are well prepared to launch Dasynoc on the US market upon approval later this year,” says Per Andersson.

The submission of the updated FDA application follows the plan communicated in January of this year. Xspray Pharma reiterates the assessment that the company has sufficient funding to take Dasynoc to approval, regardless of whether the FDA’s review takes two or six months from the re-submission.