Cytokinetics Granted Orphan Drug Designation for Reldesemtiv for the Treatment of Amyotrophic Lateral Sclerosis
Cytokinetics, Incorporated (CYTK)
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Source: GlobeNewswire
SOUTH SAN FRANCISCO, Calif., Dec. 18, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to reldesemtiv for the treatment of amyotrophic lateral sclerosis (ALS). Previously reldesemtiv was granted orphan drug designation for the treatment of spinal muscular atrophy (SMA) by the FDA and by the European Medicines Agency. In collaboration with Astellas, Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA), as a potential treatment for people with ALS, SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue. The FDA, through its Office of Orphan Products Development (OOPD), grants orphan status to drugs and biologic products that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in
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CYTK
Earnings
- 11/6/24 - Miss
CYTK
Sec Filings
- 11/14/24 - Form SC
- 11/13/24 - Form 4
- 11/12/24 - Form 144
- CYTK's page on the SEC website