US Regulator Accepts Orexo's New Drug Application for Anaphylaxis Treatment

02:49 AM EDT, 09/14/2026 (MT Newswires) -- Orexo (ORX.ST) said Monday that the US Food and Drug Administration accepted the investigational new drug application for OX640, the nasally administered epinephrine powder to treat anaphylaxis. The Swedish pharmaceutical company developed the drug candidate using its drug delivery platform AmorphOX, which eliminates the need for injection and provides a reliable administration of epinephrine. The new drug application was backed by positive results from clinical studies, where OX640 showed rapid absorption of epinephrine, a positive pharmacokinetic profile, and good tolerability, the company said.