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.
You may also be interested in...
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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.
Pipeline is concentrated around Phase II, but sponsors have a few chances to see how FDA handles its ‘foundational constructs’ for psychedelic drugs, led by Lykos’ pending NDA for PTSD and Compass Pathways’ Phase III synthetic psilocybin COMP360 for treatment-resistant depression.