Brief: Xspray Pharma's Dasynoc Application Resubmission Accepted By FDA, Launch Targeted In H2

Xspray Pharma publ AB

11/03/2026 14:57

March 11 (Reuters) - Xspray Pharma publ AB XSPRAY.ST:

FDA ACCEPTS RESUBMITTED APPLICATION FOR MARKET APPROVAL OF DASYNOC – PDUFA DATE AUGUST 25, 2026

PLANS TO BE ABLE TO LAUNCH BOTH DASYNOC AND DRUG CANDIDATE XS003 (NILOTINIB) IN H2 2026

GMP-RELATED OBSERVATIONS AGAINST THIRD-PARTY MANUFACTURER REMAIN

RESPONSIBILITY FOR RESOLVING ISSUES RELATED TO GMT RESTS WITH FACILITY'S NEW OWNER BENTA GROUP

MEASURES BEING IMPLEMENTED TO GET FACILITY APPROVED FOR NEW DRUGS IN TIME FOR LAUNCH

Source text: ID:nMFN9fSm5C

Further company coverage: XSPRAY.ST

 (Gdansk Newsroom)

 ((gdansk.newsroom@thomsonreuters.com; +48 58 7696600;))