Xspray Pharma Hit with Third FDA Complete Response Letter for Dasynoc Over Manufacturing Issues
On August 19, 2026, Xspray Pharma announced it received a third Complete Response Letter (CRL) from the U.S. FDA regarding its New Drug Application (NDA) for Dasynoc, an amorphous, lower-dose formulation of dasatinib developed for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).
Crucially, the FDA did not raise any questions regarding Dasynoc's clinical data, bioequivalence, or stability, and the risk of medication error cited in previous CRLs has been resolved. Instead, the rejection was tied entirely to outstanding Good Manufacturing Practice (GMP) observations at Xspray's third-party contract manufacturer1, NerPharMa, as well as an agency request for additional commercial-scale consecutive batch data following implemented corrective actions.
NerPharMa has informed the FDA that facility remediation is complete, though the FDA has not yet determined if a physical reinspection is required. Xspray plans to prioritize the manufacture of consecutive commercial batches to satisfy the FDA's request and intends to resubmit the NDA as soon as possible in late 2026 to secure a new PDUFA date.
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An instance of Flawless clinical profiles cannot salvage a drug from manufacturing facility failures. — Even with the FDA raising no questions about clinical data, bioequivalence, or stability, a manufacturing partner's facility deficiencies repeatedly block approval. ↩︎