The US FDA has commenced an inspection of Xspray Pharma’s contract manufacturer NerPharMa, marking a step towards resolving manufacturing compliance issues that have delayed approval of its two cancer treatments, Dasynoc and Nilopki. These deficiencies contributed to the FDA’s previous rejection of Dasynoc in August and Nilopki in June. The inspection’s duration and outcome remain unknown, with satisfactory manufacturing compliance still essential before either treatment can receive US approval.
Xspray maintains its target to resubmit both New Drug Applications in Q426, following confirmation in October that filings can proceed independently of NerPharMa’s compliance status. The FDA generally aims to communicate its final inspection classification within 90 days of completion, providing investors with a potential near-term regulatory milestone. A satisfactory outcome would remove a significant shared barrier to approval, and bring Xspray closer to launching its first products in the US, subject to the remaining regulatory reviews.