Atossa Therapeutics, announced that the U.S. Food and Drug Administration (“FDA”) Office of Orphan Products Development has granted Orphan Drug Designation to (Z)-endoxifen for the treatment of Duchenne muscular dystrophy (“DMD”). >> Learn More: Atossa Therapeutics Receives FDA Rare Pediatric Disease Designation for (Z)-Endoxifen
“In addition to the previously received Rare Pediatric Disease designation, Orphan Drug Designation for (Z)-endoxifen in Duchenne muscular dystrophy is an important milestone for Atossa as we move forward developing (Z)-endoxifen for this serious and debilitating disease,” noted Steven C. Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer.
Atossa plans to continue engaging with FDA as it advances development efforts and will provide updates as appropriate.
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