Cytokinetics Shares Jump After FDA Fast Track Designation for Omecamtiv Mecarbil

By Robb M. Stewart

Cytokinetics Inc. shares rallied Monday after the biopharmaceutical company and Amgen were granted fast track designation for omecamtiv mecarbil, a novel selective cardiac myosin activator being developed for the potential treatment of chronic heart failure with reduced ejection fraction.

In early trading, Cytokinetics' shares rose 20% to $18.97, for a year-to-date advance of 79%. Amgen was up 1% at $237.05.

Fast track designation by the U.S. Food and Drug Administration can expedite the review of a drug intended for the treatment of a serious or life-threatening disease or condition and which demonstrates the potential to address an unmet medical need.

Amgen executive David Reese Friday said the designation represents an important milestone in the development of omecamtiv mecarbil. "Today, half of heart failure patients will die within five years of diagnosis, underscoring the urgent need for new therapies," he said.

The companies said that Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure, one of the largest Phase 3 global cardiovascular outcomes studies in heart failure, is designed to evaluate whether treatment with omecamtiv mecarbil when added to standard of care reduces the risk of heart failure events and CV death in patients. GALACTIC-HF enrolled 8,256 patients in 35 countries who were either hospitalized at the time of enrollment for a primary reason of heart failure or had a hospitalization or admission to an emergency room for heart failure within one year prior to screening. Top-line results from GALACTIC-HF are expected in the fourth quarter.

Omecamtiv mecarbil is being developed under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier.

Write to Robb M. Stewart at [e-mail]

(END) Dow Jones Newswires

May 11, 2020 10:29 ET (14:29 GMT)

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