FDA Accepts Investigational New Drug Application for OX640 for Anaphylaxis Treatment

Orexo AB announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for OX640. This needle-free, nasally administered powder formulation of epinephrine is intended for the emergency treatment of anaphylaxis. The IND acceptance enables Orexo to initiate its pivotal clinical development program for OX640, with the first pivotal study planned for Q4 2026 and regulatory submission targeted for 2028.