On June 27, 2025 Xspray Pharma AB reported that the U.S. Food and Drug Administration (FDA) has conducted a successful Pre-Approval Inspection (PAI) of the company’s manufacturing lines, located at a contract manufacturing partner (Press release, Xspray, JUN 27, 2025, View Source [SID1234655392]). The inspection confirms that production of the product candidate Dasynoc is fully compliant with current Good Manufacturing Practice (cGMP) standards, marking a key regulatory milestone.

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"The result of the FDA’s inspection represents a major milestone on our path toward marketing approval for Dasynoc," said Per Andersson, CEO of Xspray Pharma. "In parallel, and in consultation with the FDA, we have revised the tablet strengths to address previously identified risks of medication error with the reference product. Together, these steps significantly reduce regulatory uncertainty ahead of our October 7 PDUFA date."

Xspray continues to prepare for the commercial launch of Dasynoc—an improved formulation of dasatinib designed to deliver more predictable and consistent exposure, developed for patients with chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The proprietary HyNap platform is central to these improvements and enables future expansion into additional oncology indications.