Xspray Pharma provides regulatory status update for Dasynoc and Nilopki

Preparations for the resubmission of both NDAs are progressing as expected. Following dialogue with the FDA, Xspray has confirmation that both Nilopki and Dasynoc resubmissions may occur independent of the cGMP status of NerPharMa.

For both Dasynoc and Nilopki, the required additional consecutive commercial-scale batches and related analytics have commenced. For Nilopki, Xspray continues to prepare the necessary documentation to establish dose correspondence with Tasigna® at a dose level relevant only to a patient sub-population with the 96mg. 

Xspray’s assessment is that the remaining Xspray-controlled activities required for resubmission of both NDAs can be completed in time to support resubmission in the fourth quarter of 2026.

With respect to both NDAs, the cGMP status of Xspray’s third-party manufacturing facility, NerPharMa, remains an important part of FDA’s approvability assessment. Final facility clearance remains necessary before approval can be granted. NerPharMa has informed FDA that it considers the facility inspection-ready since June 2026. They have completed the CAPA plan agreed with the FDA and communicated this accordingly. What remains is the FDA's assessment. The timing and nature of FDA’s next step remain outside of Xspray’s control.

“Xspray remains focused on completing the remaining regulatory steps for both Dasynoc and Nilopki as efficiently and comprehensively as possible,” says Blake Leitch, CEO of Xspray Pharma. “"The corrective work at the manufacturing site has been carried out and reported to FDA, and what remains there is FDA's assessment of it. We continue to target resubmission of both NDAs in the fourth quarter of 2026, while maintaining launch readiness and financial discipline.”

Xspray will hold a live-streamed Investor Update in Gothenburg on 2 October 2026, starting 12.30-14.00 CET. Link to follow the Investor Update live: Click here