12:06 AM EDT, 08/19/2026 (MT Newswires) -- Xspray Pharma (XSPRAY.ST) received a complete response letter from the US Food and Drug Administration for Dasynoc, its chronic myeloid leukemia and acute lymphoblastic leukemia drug candidate. The pharmaceutical company said Wednesday that the complete response letter relates to the resolution of good manufacturing practice inspections at its third-party manufacturer NerPharMa. The issues, however, were not related to Dasynoc's clinical data, bioequivalence or stability. Xspray Pharma added that NerPharMa concluded all remediation work at the site and notified the regulator, who will now decide whether a reinspection is needed. In addition, Xspray will prioritize producing additional commercial-scale batches to satisfy the US FDA's additional data request and plans to resubmit the application in 2026 for a new Prescription Drug User Fee Act date.

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