Cytokinetics Announces Additional Results From GALACTIC-HF to be Presented at the 17th Global Cardiovascular Clinical Trialis...
01 December 2020 - 11:30PM
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced additional
results from GALACTIC-HF (
Global
Approach to
Lowering
Adverse
Cardiac Outcomes
Through
Improving
Contractility in
Heart
Failure), the Phase 3 event driven cardiovascular
outcomes clinical trial of omecamtiv mecarbil, will be presented at
the 17th Global Cardiovascular Clinical Trialists Forum (CVCT) 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,
COSMIC-HF and GALACTIC-HF. CVCT is a global invitation-only meeting
of opinion leaders across clinical research, industry and
regulatory authorities.
Session Title: Targeting the
Vessels and the Heart: Oral Soluble Guanylate Cyclase Stimulator
(Vericiguat) and Cardiac Myosin Activation (Omecamtiv
Mecarbil)Presentation Title:
GALACTIC-HF Main ResultsPresenter: 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, COSMIC-HF and
GALACTIC-HFDate: Sunday, December 6,
2020Time: 3:30 PM Central European Time
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 considering potential advancement
of reldesemtiv to Phase 3 pending ongoing regulatory interactions.
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 relating to the METEORIC-HF clinical trial;
Cytokinetics’ activities to advance the development of omecamtiv
mecarbil; 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
potential approval of omecamtiv mecarbil by the FDA or any other
regulatory authority; Amgen’s fulfillment of its undertakings
regarding transition of the omecamtiv mecarbil and AMG 594 programs
to Cytokinetics; any decision on the part of Servier to maintain or
terminate its sublicense in respect of omecamtiv mecarbil prior to
the effectiveness of the termination of the Amgen-Cytokinetics
collaboration; 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 and activities with
respect to the transfer of rights to develop and commercialize
omecamtiv mecarbil and AMG 594 to Cytokinetics; 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) 290-3060
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