Xspray Pharma (XSPRAY) FDA announcement summary

Introduction and purpose

• The conference addressed the recent Complete Response Letter (CRL) from the FDA regarding Dasynoc and provided updates on regulatory and commercial plans.

• Emphasis was placed on the ongoing need for improved dasatinib therapies and the commercial opportunity in the U.S. market.

Details of approval or decision

• The FDA issued a CRL for Dasynoc due to outstanding regulatory requirements and GMP observations at the NerPharMa facility, requesting additional commercial-scale batch data after corrective actions.

• No new fundamental issues or concerns were identified regarding clinical data, bioequivalence, or stability; previous medication error risks have been resolved.

Impact on industry and stakeholders

• Dasynoc is positioned as a bioequivalent, lower-dose alternative to existing dasatinib, compatible with acid-reducing medicines.

• The company is prioritizing resources toward Dasynoc and Nilopki, potentially down-prioritizing other pipeline assets to conserve cash.

• Launch planning will prioritize production of additional commercial-scale batches to meet FDA requirements, with preparations for rapid US access for CML and ALL patients once approved.