Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) has today been informed by its contract manufacturer NerPharMa that the U.S. Food and Drug Administration (FDA) has commenced an unannounced follow-up inspection at NerPharMa’s manufacturing facility in Italy. The inspection relates to the previously identified cGMP observations at the site.
As communicated earlier, approval of the New Drug Applications (NDAs) for Dasynoc® and Nilopki® is subject to the establishment of satisfactory cGMP status at NerPharMa. The Company cannot at this stage assess the duration or outcome of the inspection but welcomes it as an important step in the on-going regulatory process.
Xspray’s plan to resubmit both NDAs in the fourth quarter of 2026 remains unchanged. As communicated on 2 October 2026, the FDA has confirmed that the resubmissions of the NDAs for Dasynoc® and Nilopki® may occur independent of NerPharMa’s cGMP status.
The FDA generally aims to notify a facility of its final inspection classification within 90 days after an inspection has been conducted. Xspray will inform the market when new material information becomes available.