Amgen Hands Omecamtiv Back To Cytokinetics
Cytokinetics Assessing Commercializing On Its Own Or With New Partner
While Amgen said the Phase III GALACTIC-HF results for omecamtiv mecarbil did not meet its high expectations for the heart failure candidate, Cytokinetics sees a path to treating certain patients.
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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.
Single Trial, Missing Companion Diagnostic May Be Insurmountable Hurdles for Cytokinetics Heart Failure Drug
Cytokinetics willingness to tweak the indication for omecamtiv mecarbil doesn’t look likely to help the drug get past a handful of safety and efficacy concerns at its 13 December advisory panel.
The biotech’s cardiology asset has failed an advanced study focused on exercise capacity in heart failure, having underwhelmed observers with past data, but hope remains that the LVEF subset could be a saving grace.