Orexo resubmits Izipry application to FDA, expects potential approval in first half of 2027

• Orexo resubmitted Izipry’s FDA application on September 29, 2026, addressing issues identified in a complete response letter.
• Potential FDA approval is expected in the first half of 2027.
• The FDA accepted OX640’s investigational new drug application for anaphylaxis, enabling a pivotal clinical program planned for the fourth quarter of 2026.
• A nonbinding agreement in principle with the US Department of Justice would settle an investigation ongoing since 2020.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Orexo AB published the original content used to generate this news brief on October 22, 2026, and is solely responsible for the information contained therein.