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Xspray Pharma (XSPRAY) investor relations material
Xspray Pharma FDA Announcement summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.FDA Announcement summary8 Oct, 2025
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.
New Dasynoc approval timeline?
Is product info request a major hurdle?
Is XS003 affected by manufacturer issues?
What is the expected Dacinoc resubmission class?
How does Dacinoc delay affect cash runway?
How will Dacinoc experience shape future FDA dialog?
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Next Xspray Pharma earnings date
Q3 20255 Nov, 2025
Next Xspray Pharma earnings date
Q3 20255 Nov, 2025
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Frequently asked questions
Xspray Pharma AB is a pharmaceutical company, which engages in the development of protein kinase inhibitors for targeted cancer treatments. Its product candidates include HyNap-Nilo and HyNap-DS. The company was founded by Lars Holmkvist, Ola Winqvist and Magnus Persson on April 3, 2003 and is headquartered in Solna, Sweden.
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