Avidity Biosciences Lead Program Gets FDA Fast-Track

 Avidity Biosciences Inc. on Monday said the U.S. Food and Drug Administration granted fast-track designation to AOC 1001, its lead program, for the genetic multisystem disorder myotonic dystrophy type 1.

The biopharmaceutical company said there are currently no approved treatments for the progressive and often fatal disease, which primarily affects skeletal and cardiac muscle.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

The FDA previously cleared Avidity to proceed with a Phase 1/2 study of AOC 1001 in adults with myotonic dystrophy type 1.

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