FDA Issues Fourth Complete Response Letter to Xspray Pharma's Dasynoc Over CDMO Issues
On August 19, 2026, Xspray Pharma received its fourth Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Dasynoc (an amorphous formulation of dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The rejection is tied entirely to outstanding Good Manufacturing Practice (GMP) observations at its third-party contract manufacturer, NerPharMa, and a request for additional consecutive commercial-scale batch data.
Importantly, the FDA did not raise any questions regarding Dasynoc's clinical data, bioequivalence, or stability, and the risk of medication error raised in previous CRLs has been resolved. Xspray intends to resubmit the application as soon as possible within 2026 to secure a new PDUFA date.
Quotes
"The FDA’s Complete Response Letter relates to the previously communicated observations at NerPharMa, concerning outstanding GMP (Good Manufacturing Practice) observations, as well as a request for additional commercial scale consecutive batch data following already implemented corrective actions. Importantly, the FDA has not raised questions regarding Dasynoc's clinical data, bioequivalence or stability. Furthermore, the risk of medication error raised in previous CRLs has been resolved." — Xspray Pharma Press Release
“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." — Blake Leitch, CEO of Xspray Pharma