Sparks

Xspray Pharma has reiterated its plan to resubmit the US New Drug Applications (NDAs) for Dasynoc and Nilopki in Q4 CY26, with preparations progressing as expected. Following discussions with the FDA, the company has confirmed that both applications can be resubmitted independently of the cGMP status of third-party manufacturer NerPharMa, reducing the risk that the filing timetable itself is delayed by the outstanding facility review. Additional consecutive commercial-scale batches and related analytical work for both products have started, while Xspray is preparing further Nilopki documentation to establish dose correspondence with Tasigna at the 96mg dose for a specific patient sub-population. Management believes the remaining activities under Xspray’s control can be completed in time for both Q4 submissions.

The main outstanding regulatory sensitivity remains NerPharMa, as FDA clearance of the facility is still required before either product can receive final approval. NerPharMa says it has been inspection-ready since June 2026 and has completed the corrective and preventive action plan agreed with the FDA, leaving the timing and nature of the agency’s next step outside Xspray’s control. The update therefore provides greater certainty around the timing of the two NDA resubmissions, while the path from resubmission to approval continues to depend materially on the FDA’s assessment of the manufacturing site.