The FDA has granted Orphan Drug designation to Cytokinetics’ (NASDAQ:CYTK) reldesemtiv for the treatment of amyotrophic lateral sclerosis (ALS).
In collaboration with Astellas, Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator, as a treatment for people with ALS, SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue.
Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
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