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0 0.0437956204379562 0.0437956204379562 0.0437956204379562 0.0423357664233577 0.0423357664233577 0.0423357664233577 0.00729927007299267
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Cytokinetics Announces Receipt of FDA Feedback Regarding Reldesemtiv in Patients With SMA

Cytokinetics, Incorporated (CYTK) 
Last cytokinetics, incorporated earnings: 3/3 04:00 pm Check Earnings Report
US:NASDAQ Investor Relations: ir.cytokinetics.com/investor-overview
Company Research Source: GlobeNewswire
SOUTH SAN FRANCISCO, Calif., Jan. 22, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it has received feedback from the U.S. Food and Drug Administration (FDA) that the Six Minute Walk Test (6MWT) is an acceptable primary efficacy endpoint for a potential registration program for reldesemtiv in patients with spinal muscular atrophy (SMA) who have maintained ambulatory function. The FDA also recommended adding a global function scale as a secondary endpoint, such as the Hammersmith Functional Motor Scale – Expanded (HFMSE). In collaboration with Astellas, Cytokinetics is developing reldesemtiv as a potential treatment for people with SMA and certain other debilitating diseases and conditions associated with skeletal muscle weakness and/or fatigue. The companies are discussing potential next steps regarding the ongoing development program for reldesemtiv in this patient population. Results from a Phase 2 clinical study of reldesemtiv in patient Show less Read more
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