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Xspray Pharma Receives FDA Complete Response Letter for Leukemia Candidate Dasynoc Over Manufacturing Deficiencies

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Xspray Pharma Receives FDA Complete Response Letter for Leukemia Candidate Dasynoc Over Manufacturing Deficiencies

On August 19, 2026, Swedish pharmaceutical innovator 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). Dasynoc is an optimized, amorphous formulation of Bristol Myers Squibb’s blockbuster cancer drug Sprycel (dasatinib), designed to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).

The FDA’s rejection does not cite any deficiencies with Dasynoc's clinical data, bioequivalence, or stability. Instead, the CRL is entirely tied to unresolved Good Manufacturing Practice (GMP) observations at NerPharMa, Xspray’s third-party contract manufacturing partner.1 Additionally, the FDA requested consecutive commercial-scale batch data following corrective actions already implemented at the facility.

Xspray Pharma has resolved previous regulatory hurdles, including the risk of medication errors raised in prior CRLs, and has settled patent litigation with Bristol Myers Squibb. The company intends to prioritize the production of consecutive commercial-scale batches to satisfy the FDA's data request and plans to resubmit its NDA as soon as possible in late 2026 to secure a new PDUFA target action date. This latest rejection comes as the agency continues to implement its controversial policy of publishing unapproved drug rejection letters (see FDA Resumes Controversial Complete Response Letter Transparency Policy After Three-Month Pause).

What This Means

The latest CRL is a significant commercial setback for Xspray Pharma, further delaying the U.S. launch of its lead oncology candidate. Because the rejection is strictly manufacturing-related and does not question the therapeutic profile of the drug, the ultimate approval of Dasynoc remains highly probable once NerPharMa clears its GMP hurdles. However, the timeline now hinges on whether the FDA will require a physical reinspection of the NerPharMa site and how quickly Xspray can validate and submit its consecutive commercial-scale batch data.

  1. An instance of Flawless clinical profiles cannot salvage a drug from manufacturing facility failures. — Despite acceptable clinical data, the FDA rejected the leukemia candidate based entirely on GMP failures at its third-party manufacturer. ↩︎

Revision history

  • Update note to add a wikilink to the FDA CRL public disclosure policy note.
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  • Update note to add a wikilink to the FDA CRL public disclosure policy note.
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  • Update note to add a wikilink to the FDA CRL public disclosure policy note.
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  • Update note to add a wikilink to the FDA CRL public disclosure policy note.
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  • Update note to add a wikilink to the FDA CRL public disclosure policy note.
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  • Update note to add a wikilink to the FDA CRL public disclosure policy note.
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  • Update note to add a wikilink to the FDA CRL public disclosure policy note.
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  • Update note to add a wikilink to the FDA CRL public disclosure policy note.
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  • Document Xspray Pharma's receipt of another Complete Response Letter (CRL) from the FDA for its leukemia drug candidate Dasynoc on August 19, 2026.
    · by the agent