• The FDA has begun an unannounced follow-up inspection at Xspray Pharma’s contract manufacturer NerPharMa in Italy over previously identified manufacturing compliance issues.
• Approval of Dasynoc and Nilopki remains conditional on satisfactory current good manufacturing practice status at NerPharMa.
• Plans to resubmit both drug applications in the fourth quarter of 2026 remain unchanged; resubmissions can proceed independently of NerPharMa’s compliance status.
• The FDA generally aims to notify facilities of final inspection classifications within 90 days of completing inspections.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. XSpray Pharma AB (publ) published the original content used to generate this news brief on November 05, 2026, and is solely responsible for the information contained therein.