Brief: Xspray Pharma Gets CRL From FDA
05/06/2026 09:05
BRIEF-Xspray Pharma Gets CRL From FDA June 5 (Reuters) - Xspray Pharma AB (publ) XSPRAY.ST:
SAID ON FRIDAY IT RECEIVED COMPLETE RESPONSE LETTER FROM U.S. FOOD AND DRUG ADMINISTRATION FOR NEW DRUG APPLICATION FOR NILOPKI
FDA CURRENTLY NOT ABLE TO APPROVE THE NDA
WILL ADDRESS REMAINING QUESTIONS WITH FDA
LONG‑TERM STRATEGY AND HYNAP PLATFORM REMAIN UNCHANGED
Source text for Workspace: nMFN9HmZ9h
Further company coverage: XSPRAY.ST
(Gdansk Newsroom)
((gdansk.newsroom@thomsonreuters.com; +48 58 769 66 00;))