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Atossa Therapeutics Receives FDA Orphan Drug Designation for Duchenne Therapy

Atossa Therapeutics Receives FDA Orphan Drug Designation for Duchenne Therapy

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.

 

More news about: quality / gmp | Published by News Bureau | January - 17 - 2026

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