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

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

Cytokinetics’ Phase III Trials Show Promise in Challenging Cardiomyopathy Treatment Dominated by BMS

Cytokinetics, Phase III trials, cardiomyopathy, Bristol-Myers Squibb (BMS), heart failure treatment, myosin inhibitors, omecamtiv mecarbil, clinical data, heart muscle contraction, cardiovascular disease.

Differences and potential advantages of aficamten compared to BMS’s Camzyos

The recent analysis from Cytokinetics has highlighted several key differences and potential advantages of aficamten compared to Bristol Myers Squibb’s Camzyos, both of which are cardiac myosin inhibitors used in the treatment of obstructive hypertrophic cardiomyopathy (HCM). Key Differences Pharmacodynamic Profile: Aficamten, being a next-generation myosin inhibitor, has a different pharmacodynamic profile compared to mavacamten […]