Cytokinetics To Move On From Omecamtiv After FDA’s Complete Response Letter
Company said it will not conduct the additional Phase III trial recommended by the US FDA. Instead, it will focus on its cardiac myosin inhibitor, aficamten, and look for partners to take omecamtiv forward.
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With a data monitoring committee finding no signs of efficacy in a Phase III trial of ALS candidate reldesemtiv, Cytokinetics can conserve cash and center on aficamten for hypertrophic cardiomyopathy.
Lessons Still To Learn: Cytokinetics’ Omecamtiv Is Over In The US, But FDA Debriefs Could Inform European Strategy
Cytokinetics will not conduct the new trial in heart failure with reduced ejection fraction (HFrEF) required by the FDA’s complete response letter for omecamtiv mecarbil.