Cytokinetics Shares Jump After FDA Fast Track Designation for Omecamtiv Mecarbil
May 11 2020 - 10:44AM
Dow Jones News
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 robb.stewart@wsj.com
(END) Dow Jones Newswires
May 11, 2020 10:29 ET (14:29 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Apr 2023 to Apr 2024