RT001 Regulatory Milestone
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RT001, Revio’s drug repurposing program for Duchenne Muscular Dystrophy (DMD), has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration. Duchenne Muscular Dystrophy is a rare, progressive neuromuscular disorder with significant morbidity and mortality, and limited therapeutic options.
Orphan Drug Designation is granted to therapies intended to treat rare diseases and provides regulatory incentives to support clinical development. In Duchenne Muscular Dystrophy, this designation reflects the significant unmet need for improved treatment options. For Revio, it aligns with our strategy of reimagining established molecules into differentiated specialty products, enabling focused execution and potentially accelerated development pathways.
RT001 is being advanced through Revio’s repurposing pipeline, which leverages prior knowledge of proven drugs to reduce development risk while maintaining scientific rigor. The program is progressing toward clinical evaluation and is informed by ongoing collaboration with patients, advocacy organizations, investigators, and development partners across the DMD community.
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