Orexo AB (publ.) (ORX) Resubmits IZIPRY NDA to FDA

Orexo resubmitted its NDA for IZIPRY (naloxone nasal powder) to the FDA on Sep 29, 2026, addressing a 2024 CRL. FDA acceptance and a review timeline are expected in the coming weeks.Material DetailsContext by AI AnalystThis is a regulatory re-entry after a 2024 CRL, aligning with Orexo’s focus on o…