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CYTK

Cytokinetics
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Amgen terminates partnership with Cytokinetics, will transition omecamtiv mecarbil and AMG 594 rights
Amgen (AMGN) has elected to terminate the Collaboration and Option Agreement with Cytokinetics (CYTK), effective May 20, 2021. The agreement was initially signed in December 20, 2006.As per termination, Amgen intends to
Seekingalpha · 22h ago
Amgen Says Has Provided Notice To Cytokinetics Of Termination Of Its Collaboration And Its Intention To Transition The Development And Commercialization Rights For Omecamtiv Mecarbil And AMG 594
THOUSAND OAKS, Calif., Nov. 23, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Company has provided notice to Cytokinetics of termination of its collaboration and its intention to transition the development
Benzinga · 23h ago
Cytokinetics Regains Rights to Develop and Commercialize Omecamtiv Mecarbil and AMG 594 From Amgen
Company Committed to Advancing Omecamtiv Mecarbil with Initial Focus on Preparations for Regulatory Interactions Following Positive Results of GALACTIC-HFCompany to Host Conference Call and Webcast Today at 8:30 AM Eastern TimeSOUTH SAN FRANCISCO, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Amgen has elected to terminate the Collaboration and Option Agreement, dated December 20, 2006 between the companies (the “Agreement”) and thereby end its collaboration with Cytokinetics, effective May 20, 2021, and intends to transition development and commercialization rights for omecamtiv mecarbil and AMG 594 to Cytokinetics. Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. AMG 594, a novel mechanism cardiac troponin activator, is in Phase 1 development for HFrEF and other types of heart failure.“We believe this is an important pivot point and opportunity for our company, as we reclaim omecamtiv mecarbil following positive Phase 3 clinical trial results,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In one of the largest heart failure clinical trials ever conducted, our novel mechanism drug candidate demonstrated positive efficacy in a diverse patient population with high unmet need and without an imbalance in the overall incidence of adverse events. We look forward to rapidly advancing next steps for omecamtiv mecarbil, which we expect will include discussions with regulatory authorities. We believe we are well prepared to press forward given our strong balance sheet and pioneering leadership in the development of muscle-directed therapies.”Terms of TerminationPursuant to the terms of the Agreement, upon the effective date of Amgen’s termination, research, development and commercialization rights for compounds, including omecamtiv mecarbil and AMG 594, will transition to Cytokinetics. In addition, Amgen will have certain obligations set forth in the Agreement, including: cooperating with Cytokinetics and its designee(s) to facilitate a reasonably smooth, orderly and prompt transition of the programs, including transfer and assignment to Cytokinetics of specified regulatory filings, data and other information; if requested by Cytokinetics, transferring inventory of compounds to Cytokinetics at Cytokinetics’ expense; to the extent possible and requested by Cytokinetics, assigning relevant third-party manufacturing agreements to Cytokinetics; and granting to Cytokinetics exclusive and non-exclusive licenses to certain intellectual property rights. Cytokinetics will have no trailing royalty payment obligations to Amgen for either omecamtiv mecarbil or AMG 594. With Cytokinetics’ consent, Amgen granted a sublicense to Les Laboratoires Servier and Institut de Recherches Internationales Servier (“Servier”) to commercialize omecamtiv mecarbil in Europe and the Commonwealth of Independent States, including Russia. Cytokinetics is party to a letter agreement with Amgen and Servier entered into in 2016, which provides that if Amgen’s rights to omecamtiv mecarbil are terminated, (i) the sublicensed rights previously granted by Amgen to Servier with respect to omecamtiv mecarbil, will remain in effect post termination of the Agreement and become a direct license or sublicense of such rights by Cytokinetics to Servier, on substantially the same terms as those in the Option, License and Collaboration Agreement between Amgen and Servier, and (ii) Amgen will, at Cytokinetics’ election, transfer to Cytokinetics or its designee (including Servier) certain ongoing development activities.GALACTIC-HF: Results and Next StepsPrimary 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, were recently presented at the American Heart Association (AHA) Scientific Sessions 2020, and were simultaneously published in the New England Journal of Medicine.1GALACTIC-HF, one of the largest Phase 3 global cardiovascular outcomes trials in heart failure ever conducted, enrolled 8,256 patients who were at risk of hospitalization and death, despite being well treated on standard of care therapy. After a median duration of follow-up of 21.8 months, the trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care. No reduction in the secondary endpoint of time to CV death was observed and no other secondary endpoints were met in accordance with the prespecified statistical analysis. The effect of omecamtiv mecarbil was generally consistent across prespecified subgroups and with a potentially greater treatment effect suggested in patients with a lower left ventricular ejection fraction.Cytokinetics has received positive feedback from key heart failure opinion leaders on the primary results, with particular interest in the potential role of omecamtiv mecarbil in the treatment of advanced heart failure patients who remain at risk for hospitalization despite being treated with standard of care regimens. The company will be conducting market research to gain additional feedback from physicians and payors to inform the potential path forward. Cytokinetics expects to seek regulatory feedback regarding a potential registration path for omecamtiv mecarbil, subject to cooperation and transitions from Amgen. In parallel, Cytokinetics plans to conduct commercial readiness assessments and to evaluate potential partnering opportunities, including co-promotion options in North America as well as licensing in other territories.Conference Call and Webcast InformationMembers of Cytokinetics' senior management team will host a conference call and webcast today, November 23, 2020, at 8:30 AM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 2184075.An archived replay of the webcast will be available via Cytokinetics' website until December 7, 2020. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 2184075 from November 23, 2020 at 11:30 AM Eastern Time until December 7, 2020.About CytokineticsCytokinetics 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 StatementsThis 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: Cytokinetics Diane Weiser Senior Vice President, Corporate Communications, Investor Relations (415) 290-7757References 1. Teerlink J et al. NEJM. 2020
GlobeNewswire · 23h ago
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Cytokinetics Names Nancy Wysenski to Board of Directors
GlobeNewswire · 3d ago
Cytokinetics Reports Preclinical Data For CK-274, CK-271 Shared In Poster Presentations At American Heart Association Scientific Sessions
Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that preclinical data for CK-3773274 (CK-274) and CK-3772271 (CK-271) were shared in poster presentations at the American Heart Association (AHA) Scientific
Benzinga · 11/16 12:39
Cytokinetics Announces Preclinical Data for CK-3773274 and CK-3772271 Presented at the AHA Scientific Sessions 2020
New Findings from Studies of Cardiac Myosin Inhibitors in Animal Models of Hypertrophic Cardiomyopathy and Heart Failure with Preserved Ejection FractionSOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that preclinical data for CK-3773274 (CK-274) and CK-3772271 (CK-271) were shared in poster presentations at the American Heart Association (AHA) Scientific Sessions 2020. CK-274 reduced contractility and left ventricular outflow tract (LVOT) peak pressure gradient in cats with naturally occurring hypertrophic cardiomyopathy (HCM) and left ventricular outflow tract obstruction (LVOTO). In the Dahl/Salt sensitive rat model of heart failure with preserved ejection fraction (HFpEF), CK-271 attenuated the development of fibrosis and diastolic dysfunction. “We’re pleased to share preclinical data that builds on the growing body of evidence for our pipeline of cardiac myosin inhibitors,” said Brad Morgan, Ph.D., Cytokinetics’ Senior Vice President, Research and Non-Clinical Development. “Collectively, these data demonstrate the potential of this mechanism of action to reduce or arrest the development of cardiac hypercontractility in animal models which may support application in patients with diseases of hypercontractility including HCM and HFpEF.”Previous preclinical data has shown that CK-274 produces exposure related effects on cardiac contractility in healthy animals and mouse models of HCM. New preclinical data demonstrated dose-related changes in left ventricular (LV) systolic function and reductions in LVOT peak pressure gradient in cats with naturally occurring HCM and LVOTO due to the A31P mutation in cardiac myosin binding protein C (cMyBP-C). Treatment with CK-274 (1 mg/kg) reduced mean left ventricular (LV) fractional shortening at 6, 24, and 48 hours post-treatment (mean reduction 13.6%, p = 0.03; 15.4%, p = 0.01; 11.6%, p = 0.02, respectively). In addition to lowering the hypercontractility in cats with naturally occurring HCM and LVOTO, CK-274 reduced the left ventricular outflow tract peak pressure gradient in concentration related manner (median pressure gradient at baseline 27.1 mmHg [interquartile range {IQR} 18.3–33.3] vs 24 hours post-drug, 7.3 mmHg [IQR 14.2–19.7], p= 0.01). CK-274 was well tolerated and no changes in heart rate were observed for any treatment group over time.A preclinical study of CK-271 demonstrated that treatment with this novel small molecule cardiac myosin inhibitor attenuated the development of fibrosis and diastolic dysfunction in an animal model of HFpEF. Previous studies have shown that CK-271 reduces cardiac myosin ATPase activity in vitro and cardiac contractility in vivo in healthy rats and dogs. In this study of the Dahl/Salt Sensitive rat hypertension model of HFpEF, six weeks of treatment with CK-271 reduced fractional shortening (HS: 53.8 ±1.4 vs HS + CK-271: 42.7 ±1.0%, p< 0.0001) and reduced high salt diet-induced diastolic dysfunction, including reductions in isovolumic relaxation time (IVRT) (HS: 22.8 ±0.6 vs HS + CK-271: 19.5 ±0.5 ms, p< 0.0001) and left atrial area (HS: 42.5 ±2.2 vs HS + CK-271: 35.4 ±0.8 mm2, p< 0.0001). CK-271 also reduced the development of cardiac fibrosis induced by a high salt diet (HS: 5.0 ±0.6 vs HS + CK-271: 3.5 ±0.3%, p< 0.05). These results suggest that cardiac myosin inhibition may be a novel approach to mitigate the development of HFpEF.About CytokineticsCytokinetics 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 collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF, of which topline results were recently reported, and METEORIC-HF, which is ongoing. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) 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 is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (not including FSTAs). Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. 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 StatementsThis 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 timing, design and results of Cytokinetics’ preclinical trials of CK-274 or CK-271; the potential benefits of CK-274 or CK-271; Cytokinetics’ and its partners’ research and development activities; the timing of enrollment of patients in Cytokinetics’ and its partners’ clinical trials; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics’ 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; patient enrollment for or conduct of clinical trials may be difficult or delayed; 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; Cytokinetics’ partners decisions with respect to research and development activities; 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: Cytokinetics Diane Weiser Senior Vice President, Corporate Communications, Investor Relations (415) 290-7757
GlobeNewswire · 11/16 12:30
Cytokinetics Announces Presentations Related to Health Economics and Outcomes Research in Heart Failure and Hypertrophic Cardiomyopathy at the AHA Scientific Sessions 2020
SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new findings from analyses of claims data and electronic health records related to heart failure and hypertrophic cardiomyopathy (HCM) were shared in three poster presentations at the American Heart Association (AHA) Scientific Sessions 2020. Two posters related to heart failure included one detailing analyses of outcomes highlighting the high unmet need in these patients with reduced ejection fraction (HFrEF) and a worsening heart failure event, and another one presenting data on spending for hospitalized Medicare patients with heart failure underscoring the high costs of their healthcare. An additional poster presented demographics and clinical characteristics of patients with HCM. “These presentations and analyses related to heart failure underscore the growing economic burden of this disease which, despite standard of care, is accompanied by a high risk of hospitalization and cardiovascular death,” said Robert I. Blum, President and Chief Executive Officer of Cytokinetics. “Furthermore, the analyses of patients with HCM adds to our understanding of this complex disease as we continue to advance and refine our clinical development program for CK-274, our next-in-class cardiac myosin inhibitor.”Findings in Heart Failure Detail High Risk Population and High Spending Among Hospitalized Patients The first analysis, conducted in collaboration with Duke Clinical Research Institute, characterized outcomes of patients with HFrEF and a recent worsening heart failure event (WHF), defined as an emergency department visit or hospitalization with heart failure as the primary discharge diagnosis within 12 months prior to their index echocardiogram. A total of 3,867 patients aged 18-85 with chronic symptomatic HFrEF were identified via electronic health records from the Duke University Health System between January 2008 to December 2018. 1,668 (43.1%) had a WHF event in the year prior to index echocardiogram. Patients with a recent WHF event had more comorbidities, including the presence of renal disease (40.5% vs. 26.7%; p<0.001) as well as higher rates of mortality (hazard ratio 1.59; p<0.001), all-cause hospitalization (hazard ratio 1.51; p<0.001), and heart failure hospitalization (hazard ratio 1.85; p<0.001). Patients with a recent WHF event also had lower ejection fraction (EF) (63.5% with EF <25% vs. 48.4%; p<0.001) and higher NT-proBNP (3864 vs. 2443; p<0.001). Use of heart failure medication was statistically significantly higher in those with a recent WHF event (% on ACE-I, ARB, ARNI/Beta-Blocker/Mineralocorticoid antagonist was 87/76/53 for the WHF group and 78/71/35 for non-WHF). These results suggest that despite broad use of heart failure medication in patients who experienced a worsening heart failure event, a significant unmet need remains for new therapies.The second analysis, conducted in collaboration with Yale University School of Medicine, examined payments spanning the index hospitalization through 30-days post-discharge for Medicare beneficiaries with heart failure (HF). Using Medicare fee-for-service administrative claims data, patients hospitalized with HF from 2016-2018 were identified with the following primary discharge diagnoses (ICD-10 codes): systolic HF (50.2 and 50.4), diastolic HF (50.3), hypertensive heart disease (HHD) with HF (I11), and HHD with HF and chronic kidney disease (CKD) (I13). Of the 935,962 patients hospitalized with HF included in the analysis, 365,274 (39.0%) were hospitalized with HHD with HF and CKD, 226,929 (24.2%) with HHD with HF, 165,156 (17.6%) with diastolic HF, and 178,603 (19.1%) with systolic HF. Over time, there was a substantial increase in hospital admissions with a primary diagnosis of HHD with HF with or without CKD. Payments varied across HF diagnosis, with the highest payments for patients with HHD with HF and CKD. The total estimated mean Medicare 30-day payments for HF care were approximately $16.5 billion over the 3-year study period, with little change in spending year to year. These results underscore the high cost of heart failure related health care, especially for hospitalizations.Demographics and Clinical Characteristics of Patients with Obstructive HCMIn a retrospective analysis of demographics and clinical characteristics of adult patients with obstructive HCM (oHCM), patients were identified from electronic health records from 39 Integrated Delivery Networks (IDN) in the IBM Explorys database from 2010 through 2018. Of 8,792 patients, 53.0% were female, and 81.2% Caucasian (mean index age: 61.8 years). Primary insurance type was private (58.9%) and 54.9% of patients lived in the Midwest. Mean BMI at index was 30.4 and 30.9% were nondrinkers. The mean Quan-Charlson Comorbidity Index was 6.35% with the most common comorbidities being congestive heart failure (31.9%), chronic pulmonary disease (20.1%), and diabetes without chronic complications (16.9%). Cardiovascular (CV) drug rates included beta blockers (80.5%), calcium channel blockers (46.0%), ACE inhibitors (27.7%), ARBs (18.8%), disopyramide (2.4%) and amiodarone (13.0%). Surgical procedure rates included septal myectomy (22%), ablation (19.8%), implantable cardioverter defibrillator (11.2%), and heart transplantation (0.3%). Major residual side effects subsequent to surgical procedures included atrial fibrillation (31.4%) and reintervention (15.6%). Common reintervention procedures included ablation and septal myectomy. The results from this analysis of a large, diverse, national sample of patients with obstructive HCM may be used to compare the characteristics of patients with obstructive HCM in the general population and those treated in centers of excellence.About CytokineticsCytokinetics 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 collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF, of which topline results were recently reported, and METEORIC-HF, which is ongoing. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) 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 is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (not including FSTAs). Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. 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 StatementsThis 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, including the results thereof; 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 regulatory approval for 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: Cytokinetics Diane Weiser Senior Vice President, Corporate Communications, Investor Relations (415) 290-7757
GlobeNewswire · 11/16 12:30
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The average CYTK stock price target is 28.78 with a high estimate of 43.00 and a low estimate of 14.00.
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About CYTK
Cytokinetics Inc. is a late-stage biopharmaceutical company. The Company is focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. It is focused on the discovery and development of small molecule therapeutics that modulate muscle function for the treatment of serious diseases and medical conditions. The Company is developing small molecule drug candidates, which are specifically engineered to enhance muscle function and contractility. Its lead drug candidates in clinical development are: omecamtiv mecarbil, a cardiac myosin activator; AMG 594, a cardiac troponin activator; reldesemtiv, a fast-skeletal muscle troponin activator (FSTA) and CK-3773274 (CK-274), a cardiac myosin inhibitor.
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