Cytokinetics’ omecamtiv mecarbil Fast Track’d for heart failure

Cytokinetics (NASDAQ:CYTK) and exclusive licensee Amgen (NASDAQ:AMGN) announce that the FDA has designated omecamtiv mecarbil for Fast Track review for the potential treatment of heart failure patients with reduced ejection fraction.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

A large-scale Phase 3 clinical trial, GALACTIC-HF, is in process with topline results expected in Q4.

Omecamtiv mecarbil is a cardiac myosin activator. Myosin is a protein in heart muscle that is responsible for converting chemical energy into the mechanical energy that results in a heartbeat. Cardiac myosin activators increase systolic ejection time which results in an increase in cardiac contractility and more oxygen-efficient cardiac function.

https://seekingalpha.com/news/3572176-cytokinetics-omecamtiv-mecarbil-fast-trackd-for-heart-failure