Cytokinetics Announces Secondary Analysis From GALACTIC-HF to Be Presented in Late Breaking Clinical Trial Session at America...
March 18 2021 - 7:30AM
Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data
from a secondary analysis of GALACTIC-HF (
Global
Approach to
Lowering
Adverse
Cardiac Outcomes
Through
Improving
Contractility in
Heart
Failure) assessing the effect of omecamtiv
mecarbil on clinical outcomes in relationship to patient baseline
ejection fraction will be presented in a Late Breaking Clinical
Trial session at the American College of Cardiology 70th Annual
Scientific Session & Expo (ACC.21) by John Teerlink, M.D.,
Professor of Medicine, University of California San Francisco,
Director of Heart Failure, San Francisco Veterans Affairs Medical
Center and Executive Committee Chair, GALACTIC-HF.
Title: 410-16 Impact Of
Ejection Fraction On The Therapeutic Effect Of Omecamtiv Mecarbil
In Patients With Heart Failure And Reduced Ejection Fraction: A
Secondary Analysis From GALACTIC-HF (Global
Approach To Lowering
Adverse Cardiac Outcomes
Through Improving
Contractility In Heart
Failure)Presenter: John Teerlink,
M.D., Professor of Medicine, University of California San
Francisco, Director of Heart Failure, San Francisco Veterans
Affairs Medical Center and Executive Committee Chair,
GALACTIC-HFDate: May 17, 2021Session
Title: Late-Breaking Clinical Trials IVSession
Time: 8:00 – 9:15 AM ETPresentation Time:
9:00 – 9:10 AM ET
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators and next-in-class muscle
inhibitors as potential treatments for debilitating diseases in
which muscle performance is compromised and/or declining. As a
leader in muscle biology and the mechanics of muscle performance,
the company is developing small molecule drug candidates
specifically engineered to impact muscle function and
contractility. Cytokinetics is preparing for regulatory
interactions for omecamtiv mecarbil, its novel cardiac muscle
activator, following positive results from GALACTIC-HF, a large,
international Phase 3 clinical trial in patients with heart
failure. Cytokinetics is conducting METEORIC-HF, a second Phase 3
clinical trial of omecamtiv mecarbil. Cytokinetics is also
developing CK-274, a next-generation cardiac myosin inhibitor, for
the potential treatment of hypertrophic cardiomyopathies (HCM).
Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of
CK-274 in patients with obstructive HCM. Cytokinetics is also
developing reldesemtiv, a fast skeletal muscle troponin activator
for the potential treatment of ALS and other neuromuscular
indications following conduct of FORTITUDE-ALS and other Phase 2
clinical trials. The company is preparing for the potential
advancement of reldesemtiv to a Phase 3 clinical trial in ALS.
Cytokinetics continues its over 20-year history of pioneering
innovation in muscle biology and related pharmacology focused to
diseases of muscle dysfunction and conditions of muscle
weakness.
For additional information about Cytokinetics,
visit www.cytokinetics.com and follow us on Twitter, LinkedIn,
Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the "Act"). Cytokinetics disclaims any intent or
obligation to update these forward-looking statements and claims
the protection of the Act's Safe Harbor for forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to the GALACTIC-HF clinical trial,
statements indicating that the actual top-line results of the
GALACTIC-HF clinical trial will be available or presented at the
Late Breaking Clinical Trial session at the American Heart
Association (AHA) Scientific Sessions 2020 or at any other specific
time or event; statements relating to the METEORIC-HF clinical
trial; the potential benefits of omecamtiv mecarbil, including its
ability to represent a novel therapeutic strategy to increase
cardiac muscle function and restore cardiac performance; the timing
and likelihood of any regulatory submissions or approval of
omecamtiv mecarbil, Cytokinetics' and its partners' research and
development activities; the design, timing, results, significance
and utility of preclinical and clinical results; and the properties
and potential benefits of Cytokinetics' other drug candidates. Such
statements are based on management's current expectations, but
actual results may differ materially due to various risks and
uncertainties, including, but not limited to, potential
difficulties or delays in the development, testing, regulatory
approvals for trial commencement, progression or product sale or
manufacturing, or production of Cytokinetics' drug candidates that
could slow or prevent clinical development or product approval;
Cytokinetics' drug candidates may have adverse side effects or
inadequate therapeutic efficacy; the FDA or foreign regulatory
agencies may delay or limit Cytokinetics' or its partners' ability
to conduct clinical trials; Cytokinetics may be unable to obtain or
maintain patent or trade secret protection for its intellectual
property; the nature of Amgen's decisions with respect to the
design, initiation, conduct, timing and continuation of development
activities for omecamtiv mecarbil; standards of care may change,
rendering Cytokinetics' drug candidates obsolete; competitive
products or alternative therapies may be developed by others for
the treatment of indications Cytokinetics' drug candidates and
potential drug candidates may target; and risks and uncertainties
relating to the timing and receipt of payments from its partners,
including milestones and royalties on future potential product
sales under Cytokinetics' collaboration agreements with such
partners. For further information regarding these and other risks
related to Cytokinetics' business, investors should consult
Cytokinetics' filings with the Securities and Exchange
Commission.
Contact:CytokineticsDiane WeiserSenior Vice
President, Corporate Communications, Investor Relations(415)
290-7757
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