Atossa Therapeutics, Inc announced that the US Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation (ODD) to (Z)-endoxifen for the treatment of Duchenne Muscular Dystrophy (DMD).
"In addition to the previously received Rare Paediatric 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, MD, PhD, President and Chief Executive Officer, Atossa Therapeutics.
The company plans to continue engaging with FDA as it advances development efforts and will provide updates as appropriate.
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