Xspray Pharma Receives FDA Complete Response Letter for Leukemia Candidate Dasynoc Over CDMO Manufacturing Deficiencies
On August 19, 2026, Swedish specialty pharmaceutical company Xspray Pharma announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for Dasynoc (amorphous dasatinib). The decision, which came less than a week before the scheduled August 25, 2026 PDUFA target action date, marks the fourth regulatory rejection for the leukemia candidate.
CDMO GMP Deficiencies and Batch Data Requests
The CRL is tied directly to outstanding Good Manufacturing Practice (GMP) observations at NerPharMa, Xspray's third-party contract development and manufacturing organization (CDMO). Additionally, the FDA requested data from consecutive commercial-scale manufacturing runs to verify the effectiveness of corrective actions already implemented at the site.
Importantly, the FDA raised no concerns regarding Dasynoc's clinical data, bioequivalence, or stability. Furthermore, the risk of medication error that had prompted previous CRLs has been successfully resolved. NerPharMa has completed its remediation work and notified the FDA, though the agency has yet to determine if a physical reinspection is required.
Xspray's CEO, Blake Leitch, commented on the regulatory update:
"The CRL confirms that the remaining uncertainty is now linked to NerPharMa sufficiently addressing the FDAs observations at their manufacturing site and batch data from consecutive manufacturing runs being provided. As expected, this will require a NDA resubmission. We had already targeted to proceed with commercial manufacturing as part of our operational plan. We will accelerate this step to ensure a resubmission will occur this as soon as possible in 2026..."
Clinical Profile and Competitive Edge
Dasynoc is an amorphous formulation of dasatinib developed using Xspray's patented HyNap technology. It has demonstrated bioequivalence to Bristol Myers Squibb's Sprycel at a 30% lower dose due to its superior solubility profile. Dasynoc's key competitive advantage is its compatibility with proton pump inhibitors (PPIs) and other acid-reducing medications, which are frequently co-prescribed to patients with chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) but can severely limit the absorption of conventional dasatinib.
Xspray plans to prioritize the manufacture of the requested consecutive commercial-scale batches and remains committed to resubmitting the NDA before the end of 2026 to secure a new PDUFA date.