Atossa Therapeutics receives FDA RPD designation to (Z)-Endoxifen

Atossa Therapeutics (ATOS) announced that the U.S. Food and Drug Administration, FDA, has granted Rare Pediatric Disease, RPD, designation to (Z)-Endoxifen for the treatment of Duchenne Muscular Dystrophy, DMD. RPD designation is granted to drug candidates intended to treat serious or life-threatening diseases that primarily affect individuals from birth to 18 years of age. “This designation is an important regulatory milestone for Atossa, and we believe a strong validation of the science supporting the potential of (Z)-Endoxifen as a treatment for Duchenne Muscular Dystrophy,” said Steven Quay, M.D., Ph.D., Atossa Therapeutics President and Chief Executive Officer. “DMD is one of the most devastating childhood diseases. Families urgently need better options beyond steroids and gene-targeted approaches. While oncology remains our core focus, this milestone highlights (Z)-Endoxifen’s potential as a platform therapy in both cancer and rare diseases, opening the door to potential non-dilutive value creation through the Rare Pediatric Disease program.”