FDA grants orphan drug designation to Atossa’s (Z)-Endoxifen for Duchenne: What’s next?

FDA grants orphan drug designation to Atossa’s (Z)-Endoxifen for Duchenne: What’s next?

Atossa Therapeutics Inc. has received Orphan Drug Designation from the U.S. Food and Drug Administration for its investigational compound (Z)-Endoxifen in the treatment of Duchenne muscular dystrophy (DMD). The designation, disclosed on January 16, 2026, supplements the previously granted Rare Pediatric Disease Designation for the same compound and indication. The move marks a notable regulatory […]