Xspray Pharma (XSPRAY) FDA Announcement summary

Introduction and purpose

• Press conference held to address the FDA's complete response letter regarding the Dacinoc/Dasynoc market approval application.

• The FDA's decision is seen as a setback due to manufacturing site GMP issues, not product-related concerns.

Details of approval or decision

• FDA issued a complete response letter for the NDA due to GMP deficiencies at the contract manufacturing site, specifically in the sterile section, unrelated to the Dacinoc/Dasynoc production line.

• No issues were found with the product's own production line, which passed its PAI inspection earlier in the year.

• FDA requested additional information to confirm the appropriateness of the proposed product information and data on previously implemented corrective actions.

• The manufacturing site has been FDA-approved for over 16 years, but a recent inspection led to a different assessment than the Italian authority AIFA.

Impact on industry and stakeholders

• Only new applications are affected by the GMP classification; ongoing production and sales are not halted.

• Launch of Dacinoc/Dasynoc is delayed due to manufacturing issues outside the company's direct control.

• The company does not currently need a new share issue and expects to have sufficient funds through the summer if no launch occurs.

• Other development programs, including XS003 (nilotinib), are progressing as planned, with an NDA review expected to start soon.