Hypertrophic obstructive cardiomyopathy

FDA Approves Cytokinetics’ Myqorzo for Obstructive Hypertrophic Cardiomyopathy, Positioning It Against BMS’s Camzyos

3 weeks ago talkbio0Tagged Aficamten, Approved, Camzyos, Cytokinetics, Hypertrophic obstructive cardiomyopathy, Myers Squibb, Myqorzo, United States Food and Drug Administration

FDA approval; Cytokinetics; Myqorzo; aficamten; obstructive hypertrophic cardiomyopathy; Bristol Myers Squibb; Camzyos

Cytokinetics Stock Soars After Positive Phase 3 Data as FDA Approval Decision for Aficamten Nears

4 months ago talkbio0Tagged Aficamten, Approved, Cytokinetics, Hypertrophic obstructive cardiomyopathy, PDUFA, Performance, REMS, United States Food and Drug Administration

Cytokinetics; Aficamten; FDA approval; Phase 3 trial; obstructive hypertrophic cardiomyopathy (oHCM); PDUFA date; REMS; stock performance

FDA delays decision date on Cytokinetics’ heart drug to year-end in unusual safety program back-and-forth

8 months ago talkbio0Tagged Cytokinetics, Deferred, Evaluation, Extension, Hypertrophic obstructive cardiomyopathy, Mitigation Strategy, oHCM, PDUFA, Regulatory Setback, REMS, Risk, United States Food and Drug Administration

Cytokinetics, aficamten, FDA delay, PDUFA date extension, hypertrophic obstructive cardiomyopathy (oHCM), Risk Evaluation and Mitigation Strategy (REMS), regulatory setback