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Cytokinetics, Incorporated Provides Update on New Drug Application

2022-06-17 11:36:00

On June 17, 2022, Cytokinetics, Incorporated announced that, in response to a request from the U.S. Food and Drug Administration (FDA), the company recently provided additional pharmacokinetic analyses of omecamtiv mecarbil related to the company’s new drug application (NDA). After an initial review of the company’s submission, on June 15, 2022, FDA communicated to the Company that the additional data provided constitutes a major amendment to the NDA and has extended the PDUFA date by three months to February 28, 2023 to provide time for a full review of the submission.

Cytokinetics Announces Start of Open-Label Extension Study for Patients Completing COURAGE-ALS

2022-06-16 11:30:00

Cytokinetics, Incorporated announced the start of COURAGE-ALS OLE (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS Open Label Extension), an open-label extension clinical study designed to assess the long-term safety and tolerability of reldesemtiv in people with amyotrophic lateral sclerosis (ALS). Patients will be eligible for COURAGE-ALS OLE after completing their participation in COURAGE-ALS, the Phase 3 clinical trial of reldesemtiv, a next-generation fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS. COURAGE-ALS OLE: Clinical Study Design: COURAGE-ALS OLE is an open-label extension clinical study of reldesemtiv in people with ALS who have completed participation in COURAGE-ALS. Following enrollment in COURAGE-ALS OLE, participants will continue to receive 300 mg of reldesemtiv dosed orally twice daily for 48 weeks after which they may transition into the Managed Access Program. The primary endpoint is the incidence of adverse events. Secondary endpoints include the time to the first occurrence of respiratory insufficiency or death, time to the first hospitalization, combined assessment of change in ALSFRS-R total score, time to onset of respiratory insufficiency, and survival time, changes in ALSFRS-R total score, and the slope of changes in ALSFRS-R total score.

Cytokinetics, Incorporated Announces Additional Data from Redwood-HCM Presented At the American Society of Echocardiography 33Rd Annual Scientific Sessions

2022-06-13 11:30:00

Cytokinetics, Incorporated announced that additional data from a new analysis of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) relating to the effect of treatment with aficamten on measures of cardiac structure and function were presented at the American Society of Echocardiography (ASE) 33rd Annual Scientific Sessions by Theodore Abraham, M.D., F.A.C.C., Meyer Friedman Distinguished Professor of Medicine, Clinical Chief of Cardiology; Director of Echocardiography, University of California, San Francisco. This new analysis investigated changes from baseline in echocardiographic measures of cardiac structure and function after 10 weeks of treatment with aficamten compared with placebo. At baseline, all patients (n=41) enrolled in Cohorts 1 and 2 of REDWOOD-HCM had severe left ventricular outflow tract (LVOT) obstruction, 88% had associated systolic anterior motion (SAM) of the mitral valve, and 90% had mitral regurgitation. SAM occurs when the mitral valve leaflet gets pushed against the interventricular septum during systole, resulting in obstruction of the LVOT and mitral regurgitation. Measures of cardiac structure, diastolic and mitral valve functionimproved at Week 10 in patients treated with aficamten. There was a significant reduction in left atrial volume index (p<0.01) and a trend towards a reduction in left ventricular hypertrophy (left ventricular mass index; p=0.06). Treatment with aficamten also resulted in improved ventricular relaxation and filling, as indicated by a reduction in lateral E/e’ (p<0.01) and an increase in lateral e’ (p<0.05). Additionally, treatment with aficamten improved mitral valve dynamics as noted by a reduction in the proportion of patients with SAM (placebo: 92.3% at baseline to 75.0% at Week 10; aficamten: 85.7% at baseline to 35.7% at Week 10; p=0.038 for comparison to placebo) and a trend towards a reduction in those with eccentric mitral regurgitation (placebo: 25.0% at baseline to 33.3% at Week 10; aficamten: 42.9% at baseline to 7.1% at Week 10; p=0.055 for comparison to placebo) at Week 10. Together, these data point to evidence of early signs of improved cardiac function and structure and improved mitral valve dynamics after a 10-week treatment period with aficamten.

Cytokinetics, Incorporated Presents at 33rd annual scientific session, Jun-10-2022

2022-06-13 11:30:00

Cytokinetics, Incorporated Presents at 33rd annual scientific session, Jun-10-2022 .

American Society Of Echocardiography Incorporated, 33rd annual scientific session, Jun 10, 2022 through Jun 13, 2022

2022-06-07 12:48:00

American Society Of Echocardiography Incorporated, 33rd annual scientific session, Jun 10, 2022 through Jun 13, 2022.

Cytokinetics, Incorporated Presents at The JMP Securities Life Sciences Conference 2022, Jun-15-2022 03:00 PM

2022-06-02 20:00:00

Cytokinetics, Incorporated Presents at The JMP Securities Life Sciences Conference 2022, Jun-15-2022 03:00 PM. Venue: Lotte New York Palace, 455 Madison Ave., New York City, New York, United States. Speakers: Robert I. Blum, CEO, President & Director.

Cytokinetics, Incorporated Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-13-2022 02:40 PM

2022-06-02 20:00:00

Cytokinetics, Incorporated Presents at Goldman Sachs 43rd Annual Global Healthcare Conference, Jun-13-2022 02:40 PM. Venue: Terranea Resort, Rancho Palos Verdes, California, United States. Speakers: Robert I. Blum, CEO, President & Director.

Cytokinetics, Incorporated Presents at 2022 Jefferies Global Healthcare Conference, Jun-09-2022 10:00 AM

2022-06-02 20:00:00

Cytokinetics, Incorporated Presents at 2022 Jefferies Global Healthcare Conference, Jun-09-2022 10:00 AM. Venue: Marriott Marquis, New York City, New York, United States. Speakers: Robert I. Blum, CEO, President & Director.

Cytokinetics, Incorporated has filed a Shelf Registration in the amount of $318.12826 million.

2022-05-31 00:00:00

Cytokinetics, Incorporated has filed a Shelf Registration in the amount of $318.12826 million. Security Name: Common Stock Securities Offered: 7,598,000 Transaction Features: ESOP Related Offering

Cytokinetics, Incorporated Presents at ALS Drug Development Summit, May-24-2022 through May-26-2022

2022-05-30 11:39:00

Cytokinetics, Incorporated Presents at ALS Drug Development Summit, May-24-2022 through May-26-2022. Venue: Boston, United States. Presentation Date & Speakers: May-25-2022, Andrew A. Wolff, Senior VP and Senior Fellow, Clinical Research & Development, Stacy Rudnicki, Vice President, Clinical Research.

Cytokinetics, Incorporated Presents at H.C. Wainwright Global Investment Conference 2022, May-24-2022 07:00 AM

2022-05-17 20:00:00

Cytokinetics, Incorporated Presents at H.C. Wainwright Global Investment Conference 2022, May-24-2022 07:00 AM. Venue: Fontainebleau Miami Beach Hotel, 4441 Collins Avenue, Miami Beach, Florida, United States. Speakers: Robert I. Blum, CEO, President & Director.

Cytokinetics, Incorporated - Shareholder/Analyst Call

2022-05-03 20:00:00

AGM

Cytokinetics, Incorporated, Q1 2022 Earnings Call, May 04, 2022

2022-04-20 20:00:00

Cytokinetics, Incorporated, Q1 2022 Earnings Call, May 04, 2022

Cytokinetics, Incorporated to Report Q1, 2022 Results on May 04, 2022

2022-04-20 20:00:00

Cytokinetics, Incorporated announced that they will report Q1, 2022 results at 4:00 PM, US Eastern Standard Time on May 04, 2022

Cytokinetics, Incorporated Announces Retirement of Mark A. Schlossberg as Senior Vice President, Legal, General Counsel and Secretary, Effective May 13, 2022

2022-04-15 20:34:00

On April 12, 2022, Mark A. Schlossberg, Senior Vice President, Legal, General Counsel and Secretary of Cytokinetics, Incorporated, informed Cytokinetics that he would be retiring from the company effective May 13, 2022. Mr. Schlossberg's departure is on mutually good terms between the Company and himself.

Cytokinetics, Incorporated, Annual General Meeting, May 10, 2022

2022-04-08 20:06:00

Cytokinetics, Incorporated, Annual General Meeting, May 10, 2022, at 10:00 Pacific Daylight. Location: at its headquarters, 350 Oyster Point Blvd. South San Francisco California United States Agenda: To elect the Board of Directors’ nominees, Muna Bhanji, Santo J. Costa, Esq., John T. Henderson, M.B., Ch.B., and B. Lynne Parshall, Esq., as Class III Directors, each to serve for a three-year term and until their successors are duly elected and qualified; to approve the amendment and restatement of the Amended and Restated 2004 Equity Incentive Plan to increase the number of authorized shares reserved for issuance under the Amended and Restated 2004 Equity Incentive Plan by an additional 5,998,000 shares of common stock; to ratify the selection by the Audit Committee of the Board of Directors of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2022; to approve, on an advisory basis, the compensation of named executive officers, as disclosed in the Proxy Statement accompanying this notice; and to transact such other business as may properly be brought before the meeting.

Cytokinetics, Incorporated Announces Changes to Board of Directors

2022-04-08 11:30:00

Cytokinetics, Incorporated announced changes to its Board of Directors. L. Patrick Gage, Ph.D., Chairman of the Board of Directors since March 2010, will resign from the Board effective April 8, 2022. Following Dr. Gage’s retirement, the Board has appointed John T. Henderson, M.B., Ch.B. as Chairman of the Board. Additionally, Robert A. Harrington, M.D., Arthur L. Bloomfield Professor and Chair, Department of Medicine, Stanford University, has been appointed to the company’s Board of Directors, also effective April 08, 2022. He previously served as Vice President, Research & Development in Europe, and later Japan, as well as Vice President, Medical for Pfizer’s Europe, U.S., and International Pharmaceuticals groups. Dr. Harrington is a cardiologist and the Arthur L. Bloomfield Professor of Medicine and Chair of the Department of Medicine at Stanford University. Dr. Harrington was previously the Richard Sean Stack, MD Distinguished Professor and the Director of the Duke Clinical Research Institute (DCRI) at Duke University.

Cytokinetics, Incorporated Presents at Needham 21st Annual Healthcare Conference, Apr-13-2022 11:00 AM

2022-04-06 20:00:00

Cytokinetics, Incorporated Presents at Needham 21st Annual Healthcare Conference, Apr-13-2022 11:00 AM. Speakers: Robert I. Blum, CEO, President & Director.

Cytokinetics Announces Results From METEORIC-HF and Additional Data From GALACTIC-HF Presented at the American College of Cardiology 71st Annual Scientific Session

2022-04-03 13:45:00

Cytokinetics, Incorporated announced that the full results from METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv MecarbilRelated to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF), were presented by Michael Felker, M.D., Professor of Medicine, Duke Clinical Research Institute, at the American College of Cardiology 71st Annual Scientific Session (ACC.22). Additional data from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were also presented including a healthcare resource utilization analysis and an analysis of the effect of treatment with omecamtiv mecarbil in hospitalized patients compared to outpatients. METEORIC-HF evaluated the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment in patients with HFrEF receiving standard of care therapy. The trial enrolled 276 patients in 9 countries. At baseline, patients had an average left ventricular ejection fraction (LVEF) of 27% and an average peak oxygen uptake (pVO2) of 14.7 ml/kg/min; 79% were New York Heart Association (NYHA) Functional Class II. After 20 weeks of treatment, there was no change in pVO2 in patients treated with omecamtiv mecarbil versus placebo. Patients treated with omecamtiv mecarbil had an average change from baseline in pVO2 of -0.2 ml/kg/min compared to 0.2 ml/kg/min for patients on placebo (p=0.13). There was no beneficial effect observed in any of the secondary endpoints, including change in total workload during exercise, change in ventilatory efficiency and change in daily physical activity. Adverse events, including major cardiac events, were similar between the treatment arms, even with patients reaching peak exercise.

Cytokinetics Announces Results From Cohort 3 of Redwood-HCM Presented at American College of Cardiology 71st Annual Scientific Session

2022-04-02 15:30:00

Cytokinetics, Incorporated announced that the full results from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of aficamten in patients with obstructive hypertrophic cardiomyopathy (HCM), were presented in a Moderated Poster Session by Anjali T. Owens, M.D., Medical Director, Center for Inherited Cardiac Disease, Assistant Professor of Medicine, University of Pennsylvania, at the American College of Cardiology 71st Annual Scientific Session (ACC.22). Cohort 3 of REDWOOD-HCM enrolled thirteen patients with symptomatic obstructive HCM and a resting or post-Valsalva left ventricular outflow tract gradient (LVOT-G) of =50 mmHg whose background therapy included disopyramide and, in the majority (11 out of 13 patients), a beta-adrenergic blocker. These patients remained symptomatic despite use of disopyramide and represent a group of patients resistant to available medical therapies. All patients received up to three escalating doses of aficamten once daily (5, 10, 15 mg), titrated based on echocardiographic guidance. The doses of aficamten employed were the same as those used in Cohort 1 of REDWOOD-HCM. Overall treatment duration was 10 weeks with a 4-week follow up period after the last dose. All patients completed the study on treatment. Patients in Cohort 3 demonstrated a substantial reduction in the mean (± SD) resting LVOT-G (from 50 ± 25 at baseline to 24 ± 17 mmHg at Week 10) and Valsalva LVOT-G (from 78 ± 27 to 50 ± 25 mmHg). For the resting LVOT-G, the least square mean difference (± SE) for the change from baseline to Week 10 was -28 ± 3.2 mmHg (p < 0.0001) and for the Valsalva LVOT-G was -27 ± 5.9 mmHg (p = 0.0002). The relief of obstruction was accompanied by a modest reduction in left ventricular ejection fraction (LVEF) (from 74 ± 7% at baseline to 69 ± 7% at Week 10) (Figure 2). For LVEF, the least square mean difference (± SE) for the change from baseline to Week 10 was -4.8 ± 1.9% (p = 0.018). There were no patients who experienced a reduction in LVEF below the prespecified safety threshold of 50%.

H.C. Wainwright & Co., LLC, H.C. Wainwright Global Investment Conference 2022, May 23, 2022 through May 26, 2022

2022-02-28 18:21:00

H.C. Wainwright & Co., LLC, H.C. Wainwright Global Investment Conference 2022, May 23, 2022 through May 26, 2022. Venue: Fontainebleau Miami Beach Hotel, 4441 Collins Avenue, Miami Beach, Florida, United States.

JMP Securities LLC, the JMP Securities Life Sciences Conference 2022, Jun 15, 2022 through Jun 16, 2022

2022-02-16 16:45:00

JMP Securities LLC, The JMP Securities Life Sciences Conference 2022, Jun 15, 2022 through Jun 16, 2022. Venue: Lotte New York Palace, 455 Madison Ave., New York City, New York, United States.

Cytokinetics, Incorporated Presents at American College of Cardiology Annual Scientific Session & Expo, Apr-01-2022 through Apr-04-2022

2022-02-15 18:52:00

Cytokinetics, Incorporated Presents at American College of Cardiology Annual Scientific Session & Expo, Apr-01-2022 through Apr-04-2022. Venue: Washington, District Of Columbia, United States. Presentation Date & Speakers: Apr-02-2022, Anjali T Owens, Medical Director, Center for Inherited Cardiac Disease, Assistant Professor. Apr-03-2022, Michael Felker, Professor of Medicine, Duke Clinical Research Institute. Apr-04-2022, Kieran F Docherty, Clinical Lecturer, Institute of Cardiovascular and Medical Sciences,University of Glasgow, Nihar R Desai, MPH, Associate Professor of Medicine, Associate Chief, Cardiovascular Medicine,Yale School of Medicine, Center for Outcomes Research and Evaluation.

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022

2022-02-14 21:00:00

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022. Venue: Marriott Marquis, New York City, New York, United States.

Needham & Company, LLC, Needham 21st Annual Healthcare Conference, Apr 11, 2022 through Apr 14, 2022

2022-02-11 23:04:00

Needham & Company, LLC, Needham 21st Annual Healthcare Conference, Apr 11, 2022 through Apr 14, 2022.

The Goldman Sachs Group, Inc., Goldman Sachs 43rd Annual Global Healthcare Conference, Jun 13, 2022 through Jun 16, 2022

2022-02-08 07:31:00

The Goldman Sachs Group, Inc., Goldman Sachs 43rd Annual Global Healthcare Conference, Jun 13, 2022 through Jun 16, 2022. Venue: Terranea Resort, Rancho Palos Verdes, California, United States.

The Amyotrophic Lateral Sclerosis Association, ALS Drug Development Summit, May 24, 2022 through May 26, 2022

2022-02-07 17:12:00

The Amyotrophic Lateral Sclerosis Association, ALS Drug Development Summit, May 24, 2022 through May 26, 2022. Venue: Boston, United States.

Cytokinetics, Incorporated Announces FDA Acceptance of New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure with Reduced Ejection Fraction

2022-02-04 12:30:00

Cytokinetics, Incorporated announced that the U.S. Food & Drug Administration (FDA) has accepted and filed the company’s New Drug Application (NDA) for omecamtiv mecarbil, an investigational, selective, small molecule cardiac myosin activator, for the treatment of heart failure with reduced ejection fraction (HFrEF). The FDA assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022. The FDA also indicated that it is currently not planning to hold an advisory committee meeting to discuss the application. The NDA is supported by the results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil that enrolled over 8,000 patients in 35 countries across 945 sites. GALACTIC-HF 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. Additional analyses from GALACTIC-HF demonstrated a greater treatment effect of omecamtiv mecarbil in patients with lower left ventricular ejection fraction (LVEF), as well as other characteristics that may indicate worsening heart failure.

Cytokinetics, Incorporated Announces Positive Topline Results from Cohort 3 of REDWOOD-HCM

2022-02-01 12:30:00

Cytokinetics, Incorporated announced positive topline results from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of aficamten, an investigational next-generation cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy (HCM). Cohort 3 of REDWOOD-HCM enrolled patients with symptomatic obstructive HCM and a resting or post-Valsalva left ventricular outflow tract gradient (LVOT-G) of =50 mmHg whose background therapy included disopyramide and in the majority a beta-adrenergic blocker. All patients received up to three escalating doses of aficamten once daily (5, 10, 15 mg), titrated based on echocardiographic guidance. The doses employed were the same as those used in Cohort 1 of REDWOOD-HCM. Overall treatment duration was 10 weeks with a 4-week follow up period after the last dose. In total, thirteen patients were enrolled and all patients completed the study on treatment. Results from Cohort 3 showed that substantial reductions in the average resting LVOT-G as well as the post-Valsalva LVOT-G (defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg) were achieved. These clinically relevant decreases in pressure gradients were achieved with only modest decreases in average left ventricular ejection fraction (LVEF); there were no patients whose LVEF fell below the prespecified safety threshold of 50%. New York Heart Association functional class was improved in the majority of patients participating in Cohort 3 of the trial. Pharmacokinetic data were similar to those observed in Cohorts 1 and 2. In addition, the safety and tolerability of aficamten were consistent with prior experience in REDWOOD-HCM with no treatment interruptions and no serious adverse events attributed to treatment reported by the investigators. The results from Cohort 3 of REDWOOD-HCM have been accepted for presentation at the American College of Cardiology 71st Annual Scientific Session & Expo in Washington, DC in April.

American College of Cardiology, Inc., American College of Cardiology Annual Scientific Session & Expo, Apr 01, 2022 through Apr 04, 2022

2022-01-26 12:00:00

American College of Cardiology, Inc., American College of Cardiology Annual Scientific Session & Expo, Apr 01, 2022 through Apr 04, 2022. Venue: Washington, District Of Columbia, United States.

Cytokinetics and JI XING Announce Expansion of Collaboration to Include Licensing of Omecamtiv Mecarbil in China

2021-12-20 12:30:00

Cytokinetics, Incorporated and Ji Xing Pharmaceuticals Limited announced an expansion of their collaboration by entering into an exclusive license and collaboration agreement to develop and commercialize omecamtiv mecarbil for the proposed treatment of heart failure with reduced ejection fraction (HFrEF) in Greater China. In addition to the license and collaboration agreement with JI XING, Cytokinetics has also entered into Common Stock Purchase Agreements that provide for the sale and issuance to entities affiliated with RTW of 511,182 of shares of Cytokinetics common stock at a price per share of $39.125. Pursuant to these transactions, Cytokinetics will receive committed capital of $70 million, comprised of $50 million from JI XING of upfront and near-term payments under the collaboration agreement and $20 million from RTW as proceeds for the sale of common stock. In addition, Cytokinetics will be eligible to receive up to $330 million from JI XING in additional milestone payments plus tiered royalties on the net sales of omecamtiv mecarbil in Greater China, subject to certain reductions.

Cytokinetics Incorporated Enters into License and Collaboration Agreement with Ji Xing Pharmaceuticals Limited

2021-12-20 12:30:00

On December 20, 2021, Cytokinetics, Incorporated entered into a License and Collaboration Agreement with Ji Xing Pharmaceuticals Limited, pursuant to which Cytokinetics granted to Ji Xing an exclusive license to develop and commercialize Cytokinetics’ proprietary small molecule cardiac sarcomere activator known as omecamtiv mecarbil (the “Product”) in the greater China region, namely mainland China, Hong Kong, Macau, and Taiwan. Under the terms of the License Agreement, Cytokinetics will receive from Ji Xing an upfront and near-term milestone payments of $50 million. Cytokinetics may be eligible to receive from Ji Xing additional milestone payments totaling up to $330 million for the achievement of certain commercial milestone events with respect to the Product. In addition, Ji Xing will pay to Cytokinetics tiered royalties from the mid-teens to the low twenties range on the net sales of the Product in the greater China region, subject to certain reductions for generic competition, patent expiration and payments for licenses to third-party patents. Ji Xing will be responsible for the development and commercialization of the Product in its territory at its own cost and is required to use diligent efforts to develop and commercialize the Product in the greater China region. The development of the Product will be initially focused on heart failure with reduced ejection fraction (HFrEF), and Ji Xing will have the opportunity to participate in future Cytokinetics’ global clinical trials of the Product. Cytokinetics will supply the Product to Ji Xing either as a finished product or as an active pharmaceutical ingredient. The License Agreement, unless terminated earlier, will continue on a market-by-market basis until expiration of the relevant royalty term. Ji Xing has the right to terminate the License Agreement for convenience. Each party may terminate the License Agreement for the other party’s uncured material breach, insolvency, or failure to perform due to extended force majeure events. Cytokinetics may also terminate the License Agreement if Ji Xing challenges Cytokinetics’ patents or undergoes certain change of control transactions. Product rights will revert to Cytokinetics upon termination, and, under certain circumstances, subject to a low single-digit royalty payments on the net sales of the Product in the greater China region.

Cytokinetics, Incorporated - Special Call

2021-12-20 09:14:00

Cytokinetics and JI XING Announce Expansion of Collaboration to Include Licensing of Omecamtiv Mecarbil in China; RTW to Add to Its Investment in Cytokinetics

Cytokinetics, Incorporated announced that it expects to receive $19.999996 million in funding from RTW Investments, LP

2021-12-20 00:00:00

Cytokinetics, Incorporated announced that it has entered into common stock purchase agreements with each of RTW Master Fund, Ltd., RTW Innovation Master Fund, Ltd., RTW Venture Fund Limited, funds managed by RTW Investments, LP for a private placement of 511,182 shares at a price of $39.125 per share for gross proceeds of $19,999,995.75 on December 20, 2021. The closing will occur on December 20, 2021. The Investors have agreed to certain trading and other restrictions with respect to the shares, including a restriction on sales or other transfers of the shares, subject to certain exceptions, for a period of one year from the closing date.

Cytokinetics, Incorporated Announces New Data Presented At the 32nd International Symposium on ALS/MND

2021-12-10 12:30:00

Cytokinetics, Incorporated announced that new data were presented at the 32nd International Symposium on ALS/MND including an analysis of baseline characteristics from the initial patients enrolled in COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the ongoing Phase 3 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS). In addition, supplemental analyses from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in ALS were presented, as were results from the IMPACT ALS Europe survey, a patient and caregiver survey funded in part by Cytokinetics. COURAGE-ALS: Analysis of Baseline Characteristics for First 27 Patients Enrolled: Stacy Rudnicki, M.D., Vice President, Clinical Research, Cytokinetics presented an analysis of the baseline characteristics of the first 27 patients enrolled in COURAGE-ALS. COURAGE-ALS is a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv expected to enroll approximately 555 patients with ALS. Analyses conducted post hoc from FORTITUDE-ALS, the completed Phase 2 clinical trial of reldesemtiv, suggested that treatment effects were more evident in patients with faster rates of disease progression. These findings informed the inclusion criteria for COURAGE-ALS with the aim of enrolling a higher proportion of patients with middle to fast disease progression. Key inclusion criteria in COURAGE-ALS include symptom onset within 24 months and ALS Functional Rating Scale-Revised (“ALSFRS-R”) total score of =44. COURAGE-ALS began enrolling patients in August 2021, and 27 patients had been enrolled at the time of this analysis. The disease progression rate of each patient prior to enrollment was estimated using a formula based on ALSFRS-R score at entry into the trial and duration of ALS symptoms; progression rates were categorized as slow (=0.37 points per month), middle (>0.37–0.67 points per month) and fast (>0.67 points per month). These categories were defined by equally dividing the disease progression rates of patients enrolled in FORTITUDE-ALS into tertiles. In COURAGE-ALS, the majority of the patients enrolled at the time of this analysis were middle progressors (48.2%) or fast progressors (37.0%). From this analysis it appears that adjusting the inclusion criteria in COURAGE-ALS is achieving the intended goal of increasing the proportion of patients with middle to fast disease progression rates, as compared to FORTITUDE-ALS. FORTITUDE-ALS: Grip Strength Correlated with Fine Motor Function and Arm Function: Andrew Wolff, M.D., Senior Vice President, Senior Fellow, Clinical Research and Development, Cytokinetics presented supplemental analyses from FORTITUDE-ALS evaluating the relationship between declining grip strength and motor function. In FORTITUDE-ALS, secondary and exploratory endpoints included change from baseline in the ALSFRS-R, in which higher scores represent better physical function, change from baseline in the ALS Assessment Questionnaire (“ALSAQ-5”), a patient reported measure of health status in which higher scores represent worse quality of life, and change from baseline in grip strength. Measurements for ALSFRS-R, ALSAQ-5, and bilateral grip strength were collected at Screening, Day 1, Weeks 2, 4, 8, 12 and Follow-up. For all seven time points collected, average grip strength was strongly correlated with the ALSFRS-R fine motor domain sub-score with an overall Spearman correlation coefficient of 0.723 (p<0.0001), indicating that declining grip strength was strongly correlated with decreasing ALSFRS-R fine motor domain sub-scores. Average grip strength was moderately inversely correlated with scores for Question 2 of the ALSAQ-5, which assesses the patients’ perception of difficulty using their arms and hands, with an overall Spearman correlation coefficient of -0.634 (p<0.0001), suggesting that declining grip strength was moderately correlated with increasing scores for Question 2 of the ALSAQ-5. These findings indicate that grip strength, which is frequently included as an outcome measure in ALS clinical trials and may be assessed as part of routine care for people with ALS, has clinical relevance due to its correlation to fine motor function and patient reported quality of life.

Cytokinetics, Incorporated Announces Receipt of Breakthrough Therapy Designation from FDA for Aficamten

2021-12-09 12:30:00

Cytokinetics, Incorporated announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is a next-generation cardiac myosin inhibitor in development for the potential treatment of HCM. Breakthrough Therapy Designation is granted by FDA to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint. A drug that receives Breakthrough Therapy Designation is eligible for all Fast Track designation features, intensive guidance on an efficient drug development program, and organizational commitment involving senior managers.

Cytokinetics, Incorporated Announces That the U.S. Food and Drug Administration Has Granted Breakthrough Therapy Designation for Aficamten for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy

2021-12-09 12:30:00

Cytokinetics, Incorporated announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy. Aficamten is a next-generation cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy. Breakthrough Therapy Designation is granted by FDA to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint. A drug that receives Breakthrough Therapy Designation is eligible for all Fast Track designation features, intensive guidance on an efficient drug development program, and organizational commitment involving senior managers.

Cytokinetics, Incorporated Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Nov-29-2021

2021-11-22 15:06:00

Cytokinetics, Incorporated Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference, Nov-29-2021 . Venue: New York, New York, United States.

Cytokinetics, Incorporated Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov-22-2021 10:00 AM

2021-11-19 21:08:00

Cytokinetics, Incorporated Presents at Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov-22-2021 10:00 AM.

Cytokinetics, Incorporated Announces Additional Results from GALACTIC-HF Presented at American Heart Association Scientific Sessions 2021

2021-11-15 12:30:00

Cytokinetics, Incorporated announced that additional results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 clinical trial evaluating omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF), were presented by Dr. 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, at the American Heart Association (AHA) Scientific Sessions 2021. Additional analyses presented from GALACTIC-HF focused on the effect of treatment with omecamtiv mecarbil on the risk of stroke in patients with heart failure with reduced ejection fraction (HFrEF). Among patients enrolled in the trial, 754 (9.2%) had a history of stroke. These patients were older, more likely to be non-white, and were more likely to have atrial fibrillation/flutter, hypertension, diabetes mellitus, ischemic heart disease, worse New York Heart Association (NYHA) functional class, and higher baseline NT-proBNP or troponin compared to patients with no history of stroke. A total of 194 non-fatal and fatal strokes were reported in GALACTIC-HF. Multivariate predictors of the incidence of first stroke in GALACTIC-HF included non-white race, history of stroke or percutaneous coronary intervention, and elevated baseline troponin or systolic blood pressure. The treatment effect of omecamtiv mecarbil on the primary composite endpoint of cardiovascular death or heart failure events was similar in patients with a history of stroke (hazard ratio 0.86; 95% confidence interval (CI) 0.70, 1.07; p=0.18) and in patients without a history of stroke (hazard ratio 0.93; 95% CI 0.87, 1.00; p=0.06; interaction p-value=0.40). However, among all patients who received omecamtiv mecarbil, the risk of first fatal or non-fatal stroke was reduced by 35% (hazard ratio 0.65; 95% CI 0.49, 0.87; p=0.004), and the risk of fatal stroke was reduced by 44% (hazard ratio 0.56; 95% CI 0.31, 0.99; p=0.048). Treatment with omecamtiv mecarbil was associated with greater reductions in stroke for patients with a history of stroke, reducing the risk by 77% (n=754, hazard ratio 0.23; 95% CI 0.09, 0.56; interaction p-value=0.001), as well as in patients with a history of atrial fibrillation, reducing the risk by 51% (n=3475, hazard ratio 0.49, CI 0.32, 0.76; p=0.001). Treatment with omecamtiv mecarbil also demonstrated a reduction in new onset atrial fibrillation/flutter (no atrial fibrillation/flutter present at screening: n=5987, hazard ratio 0.70, CI 0.50, 0.99; p=0.044; no history of atrial fibrillation/flutter: n=4757, hazard ratio 0.60, CI 0.37, 1.00; p=0.048). This reduction in stroke may be related to the reduction in adverse events of atrial fibrillation/flutter, as well as improvements in atrial and ventricular function that have been observed in GALACTIC-HF and previous clinical trials of omecamtiv mecarbil. These findings may have implications for the clinical impact of omecamtiv mecarbil and suggest that it has a potential added benefit of decreasing the risk of stroke in patients with HFrEF.

Cytokinetics, Incorporated Presents at 4th Annual ALS ONE Research Symposium, Nov-30-2021 02:00 PM

2021-11-10 13:45:00

Cytokinetics, Incorporated Presents at 4th Annual ALS ONE Research Symposium, Nov-30-2021 02:00 PM.

ALS One, 4th Annual ALS ONE Research Symposium, Nov 29, 2021 through Nov 30, 2021

2021-11-10 13:00:00

ALS One, 4th Annual ALS ONE Research Symposium, Nov 29, 2021 through Nov 30, 2021.

ALS One, 4th Annual ALS ONE Research Symposium, Nov 29, 2021 through Nov 30, 2021

2021-11-10 13:00:00

ALS One, 4th Annual ALS ONE Research Symposium, Nov 29, 2021 through Nov 30, 2021.

Cytokinetics, Incorporated has filed a Shelf Registration in the amount of $42.867 million.

2021-11-05 00:00:00

Cytokinetics, Incorporated has filed a Shelf Registration in the amount of $42.867 million. Security Name: Common Stock Securities Offered: 1,100,000 Transaction Features: ESOP Related Offering

Cytokinetics Announces Preclinical Data Relating to CK-3828136 Presented at the 2021 Medicinal Chemistry Gordon Research Conference

2021-10-29 11:30:00

Cytokinetics, Incorporated announced that preclinical data relating to the discovery and optimization of CK-3828136 (CK-136) were presented at the 2021 Medicinal Chemistry Gordon Research Conference in West Dover, VT. CK-136 is a novel, selective cardiac troponin activator in development for the potential treatment of diseases associated with impaired cardiac contractility, such as heart failure with reduced ejection fraction (HFrEF), right ventricular heart failure, and others. Data presented today describe the primary research objectives related to CK-136 including the identification of initial hit compounds and subsequent chemical optimization as well as preclinical characterization in biochemical assays, cardiac myocytes, and in vivo models of cardiac function. An initial cardiac troponin activator identified in screening was shown in a reconstituted sarcomere assay to selectively activate the cardiac troponin complex. Importantly, it did not inhibit phosphodiesterase 3 (PDE-3) IC50, and showed no effect on the cardiomyocyte calcium transient, indicating its selectivity. The optimization of the initial hit compound that led to CK-136 focused to maximizing the therapeutic window and its pharmacokinetic profile as could result in favorable increases in cardiac function. Preclinical studies demonstrated that the pharmacodynamic range for CK-136 was larger than that associated with omecamtiv mecarbil in similar preclinical models. Additionally, CK-136 demonstrated a pharmacokinetic profile and a projected human half-life that should enable once or twice daily dosing. These preclinical data suggest that CK-136 is a selective cardiac troponin activator with a favorable pharmacodynamic window associated with substantial increases in cardiac contractility, representing a potential approach to augmenting cardiac contractility in diseases characterized by reduced cardiac function.

Piper Sandler Companies, Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov 22, 2021

2021-10-25 10:00:00

Piper Sandler Companies, Piper Sandler 33rd Annual Virtual Healthcare Conference: Fireside Chat, Nov 22, 2021.

Cytokinetics, Incorporated to Report Q3, 2021 Results on Nov 03, 2021

2021-10-20 20:00:00

Cytokinetics, Incorporated announced that they will report Q3, 2021 results at 4:00 PM, US Eastern Standard Time on Nov 03, 2021

Cytokinetics, Incorporated, Q3 2021 Earnings Call, Nov 03, 2021

2021-10-20 20:00:00

Cytokinetics, Incorporated, Q3 2021 Earnings Call, Nov 03, 2021

Cytokinetics Outlines Go-To-Market Strategy for Omecamtiv Mecarbil and Provides Updates on Cardiovascular Pipeline

2021-10-07 11:30:00

Cytokinetics, Incorporated planed to outline the company’s go-to-market strategy for omecamtiv mecarbil in the United States, and present updates on the company’s advancing cardiovascular pipeline and strategies to build a commercial franchise at “Charting the Commercial Course,” an Analyst and Investor Day in New York and live online. The company also plans to present the clinical trial design for SEQUOIA-HCM, the Phase 3 clinical trial of aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM). THe company also presenting the design of SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM). SEQUOIA-HCM is a Phase 3 randomized, placebo-controlled, double-blind, multi-center clinical trial designed to evaluate aficamten in patients with symptomatic oHCM on background medical therapy for 24 weeks. The primary objective is to assess the effect of aficamten on change in peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) from baseline to week 24. Secondary objectives include change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to week 12 and week 24, the proportion of patients with =1 class improvement in New York Heart Association (NYHA) functional class from baseline to week 12 and week 24, change in post-Valsalva left ventricular outflow tract gradient (LVOT-G) to week 12 and week 24, the proportion of patients with post-Valsalva LVOT-G <30 mmHg, and change in total workload during CPET to week 24.

Cytokinetics, Incorporated - Analyst/Investor Day

2021-09-23 20:00:00

To provide updates on the company’s plans for commercialization and advancing cardiovascular pipeline

Cytokinetics, Incorporated Announces Results from REDWOOD-HCM and GALACTIC-H

2021-09-12 15:45:00

Cytokinetics, Incorporated announced that the full results from REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM), and additional results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil in Black patients with heart failure (HF) with reduced ejection fraction (HFrEF), were presented in a Late Breaking Clinical Trials session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Denver, CO, and virtually online. Marty Maron, M.D., Director, Hypertrophic Cardiomyopathy Center; Tufts University School of Medicine, and Principal Investigator of REDWOOD-HCM presented the primary results of REDWOOD-HCM. The baseline characteristics of patients in REDWOOD-HCM were consistent with a symptomatic patient population with high resting and Valsalva gradients reflective of substantial burden of disease. Treatment with aficamten for 10 weeks resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular (LV) outflow tract pressure gradient (LVOT-G) (p=0.0003, p=0.0004, Cohort 1 and Cohort 2, respectively) and the average post-Valsalva LVOT-G (p=0.001, p<0.0001, Cohort 1 and Cohort 2, respectively). The majority of patients treated with aficamten (78.6% in Cohort 1 and 92.9% in Cohort 2) achieved the target goal of treatment, defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg at Week 10 compared to placebo (7.7%). Reductions in LVOT-G occurred within two weeks of initiating treatment with aficamten, were maximized within two to six weeks of the start of dose titration and were sustained until the end of treatment at 10 weeks. Reversibility of the pharmacodynamic effect of aficamten was seen after a two-week washout, with resting LVOT-G, post-Valsalva LVOT-G, NT-proBNP and LVEF returning to baseline values. The observed reductions in LVOT-G were dose dependent, with patients achieving greater reductions of LVOT-G with increasing doses of aficamten. Over the 10-week study period, patients treated with aficamten in both Cohort 1 and Cohort 2 also experienced statistically significant reductions in NT-proBNP (p=0.003). Treatment with aficamten was also associated with an improvement in heart failure functional class as measured by New York Heart Association (NYHA) class. Improvement by at least one class was achieved by 31% in the placebo group, 43% of patients in Cohort 1 (p>0.1) and 64% of patients in Cohort 2 (p=0.08).Treatment with aficamten in REDWOOD-HCM was generally well tolerated. Overall, the incidence of adverse events was similar between treatment arms, there were no treatment emergent adverse events that resulted in treatment interruption or discontinuation, and no serious adverse events ascribed to aficamten by investigators. All patients completed treatment per protocol. David E. Lanfear, M.D., FACC, Section Head, Advanced Heart Failure and Transplant Cardiology; Co-Director, Center for Individualized and Genomic Medicine Research, Henry Ford Hospital, presented additional analyses of the effects of omecamtiv mecarbil in Black patients enrolled in GALACTIC-HF. Of 8,256 patients enrolled in the trial, 562 were Black (6.8%) and 285 were randomized to receive treatment with omecamtiv mecarbil. Among Black patients, treatment with omecamtiv mecarbil resulted in a trend towards reduction in the primary endpoint by 18% (HR=0.82, 95% CI 0.64-1.04), corresponding to a reduction in the primary event rate of 7.7/100 patient-years with a number-needed-to-treat of 13 patients. This result, like the overall study results, was driven primarily by a reduction in HF hospitalizations (HR=0.80) and HF events (HR=0.82), with no effect on cardiovascular mortality (HR=1.03) (Figure 2). There were no significant differences in adverse events in Black patients between the groups treated with omecamtiv mecarbil and placebo. A great majority of Black patients in GALACTIC-HF (n=535, 95%) were enrolled in the United States (n=357), South Africa (n=78) and Brazil (n=100). Black patients enrolled in these countries were younger, more often female, had lower ejection fraction (EF), more often had hypertension and diabetes, and were less likely to have atrial arrhythmias or ischemic etiology compared to white patients (each p=0.001). An analysis of Black patients enrolled only in these three countries showed that, compared to white patients from the same countries, they had a statistically similar overall benefit from treatment with omecamtiv mecarbil (HR=0.83 vs. HR=0.88), with a numerically greater risk reduction in hospitalization (HR=0.81 vs. HR=0.90).

Cytokinetics, Incorporated Presents at Cantor Global Healthcare 2021 Conference, Sep-27-2021 03:20 PM

2021-09-08 23:10:00

Cytokinetics, Incorporated Presents at Cantor Global Healthcare 2021 Conference, Sep-27-2021 03:20 PM. Venue: New York, United States.

Cytokinetics, Incorporated Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-13-2021 12:00 PM

2021-09-08 23:10:00

Cytokinetics, Incorporated Presents at H.C. Wainwright 23rd Annual Global Investment Conference, Sep-13-2021 12:00 PM. Venue: Lotte New York Palace Hotel, New York City, New York, United States.

Cytokinetics, Incorporated Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-14-2021 11:45 AM

2021-09-08 23:10:00

Cytokinetics, Incorporated Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-14-2021 11:45 AM. Venue: New Windsor, United States.

Cytokinetics, Incorporated - Special Call

2021-09-07 11:30:00

To discuss the full results from REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM)

Cytokinetics Announces Results From REDWOOD-HCM and GALACTIC-HF to Be Presented in Late Breaking Clinical Trials Session at the HFSA Annual Scientific Meeting

2021-08-31 11:30:00

Cytokinetics, Incorporated announced that the full results from REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of aficamten in patients with hypertrophic cardiomyopathy (HCM), and additional results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on Black patients with heart failure with reduced ejection fraction (HFrEF), have each been accepted for presentation in a Late Breaking Clinical Trials session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, taking place in Denver, CO, and virtually online from September 10-13, 2021.

Cytokinetics, Incorporated Updates Its Financial Guidance for 2021

2021-08-05 20:00:00

Cytokinetics, Incorporated updated its financial guidance for 2021. The company expects its revenues for 2021 will be in the range of $23 million to $28 million and operating expenses will be in the range of $230 million to $250 million.

Cytokinetics, Incorporated Announces COURAGE-ALS Is Open to Enrollment

2021-08-02 11:30:00

On August 2, 2021, Cytokinetics, Incorporated announced that COURAGE-ALS is open to enrollment. Reldesemtiv, a next-generation fast skeletal muscle troponin activator (FSTA) arising from Cytokinetics’ skeletal muscle contractility program, slows the rate of calcium release from the regulatory troponin complex of fast skeletal muscle fibers, which sensitizes the sarcomere to calcium, leading to an increase in skeletal muscle contractility. COURAGE-ALS follows FORTITUDE-ALS, a Phase 2 clinical trial of reldesemtiv that demonstrated encouraging results supportive of progression to a pivotal Phase 3 clinical trial. COURAGE-ALS: Clinical Trial Design Focused on Innovation and Accessibility: COURAGE-ALS, a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv is expected to enroll approximately 555 patients with ALS. Patients will be randomized 2:1 to receive 300 mg of reldesemtiv or matching placebo dosed orally twice daily for 24 weeks, followed by a 24-week period in which all patients will receive 300 mg of reldesemtiv twice daily. Eligible patients will be within the first two years of their first symptom of muscle weakness, have a vital capacity of =65% predicted, and a screening ALS Functional Rating Scale – Revised (ALSFRS-R) =44. Patients currently taking stable doses of Radicava® (edaravone) and/or Rilutek® (riluzole) will be permitted and randomization stratified accordingly. The primary efficacy endpoint will be change from baseline to 24 weeks in ALSFRS-R. Secondary endpoints include combined assessment of ALSFRS-R total score, time to onset of respiratory insufficiency and survival time up to week 24 using a joint rank test; change from baseline to 24 weeks for vital capacity; ALSAQ-40; and bilateral handgrip strength. Two unblinded interim analyses by the Data Monitoring Committee are planned. The first interim analysis will assess for futility, 12 weeks after approximately one-third or more of the planned sample size is randomized. A second interim analysis will also assess for futility, and there will be an option for a fixed increase in total enrollment, if necessary, to augment the statistical power of the trial. COURAGE-ALS: Elevating Patient Voice: Cytokinetics has established an ALS Patient and Caregiver Advisory Council (ALS-PAC) to elevate the voices of patients and caregivers into everything we do from planning and execution of clinical trial programs to educational materials related to the disease and our potential new therapies. Based on feedback from the ALS-PAC as well as a series of meetings with patients, caregivers, advocates, payors and healthcare professionals, the design of COURAGE-ALS incorporates elements designed to remove barriers to clinical trial participation including remote clinic visits, home nursing visits, and mobile-app based endpoint measurements. Additionally, at least one patient representative will serve on the steering committee of COURAGE-ALS to provide patient perspective on the continuing conduct of the trial and interpretation of results. The company is planning to provide continued access to reldesemtiv for participants who complete COURAGE-ALS, as well as for those who participated in our prior ALS trials. The access program will be developed with the objective to ensure safe, ethical and equitable access to reldesemtiv. FORTITUDE-ALS: Clinical Trial Design and Results: FORTITUDE-ALS was a Phase 2, double-blind, randomized, dose-ranging, placebo-controlled, parallel group study of reldesemtiv in patients with ALS. 458 eligible ALS patients from centers in the U.S., Canada, Europe and Australia were randomized (1:1:1:1) to receive either 150 mg, 300 mg or 450 mg of reldesemtiv or placebo dosed orally twice daily for 12 weeks. The primary efficacy endpoint was the change from baseline in the percent predicted SVC, a measure of respiratory function, at 12 weeks. Secondary endpoints included change from baseline in the ALS Functional Rating Scale – Revised (ALSFRS-R) and slope of the change from baseline in the mega-score of muscle strength measured by hand held dynamometry and handgrip dynamometry in patients on reldesemtiv; incidence and severity of treatment-emergent adverse events (TEAEs); and plasma concentrations of reldesemtiv at the sampled time points during the clinical trial. FORTITUDE-ALS did not achieve statistical significance for a pre-specified dose-response relationship in its primary endpoint of change from baseline in slow vital capacity (SVC) after 12 weeks of dosing (p=0.11). Similar analyses of ALSFRS-R and slope of the Muscle Strength Mega-Score yielded p-values of 0.09 and 0.31, respectively. However, patients on all dose groups of reldesemtiv declined less than patients on placebo for SVC and ALSFRS-R, with larger and clinically meaningful differences emerging over time. While the dose-response analyses for the primary and secondary endpoints did not achieve statistical significance at the level of 0.05, in a post-hoc analysis pooling the doses together, patients who received reldesemtiv in FORTITUDE-ALS declined less than patients who received placebo. The trial showed effects favoring reldesemtiv across dose levels and timepoints with clinically meaningful magnitudes of effect observed at 12 weeks for the primary and secondary endpoints. The differences between reldesemtiv and placebo in SVC and ALSFRS-R total score observed after 12 weeks of treatment were still evident at follow-up, four weeks after the last dose of study drug. The incidence of early treatment discontinuations, serious adverse events and clinical adverse events in FORTITUDE-ALS were similar between placebo and active treatment arms.

Cytokinetics, Incorporated, Q2 2021 Earnings Call, Aug 05, 2021

2021-07-22 20:00:00

Cytokinetics, Incorporated, Q2 2021 Earnings Call, Aug 05, 2021

Cytokinetics, Incorporated to Report Q2, 2021 Results on Aug 05, 2021

2021-07-22 20:00:00

Cytokinetics, Incorporated announced that they will report Q2, 2021 results at 4:00 PM, US Eastern Standard Time on Aug 05, 2021

Cytokinetics, Incorporated has completed a Follow-on Equity Offering in the amount of $275 million.

2021-07-20 00:00:00

Cytokinetics, Incorporated has completed a Follow-on Equity Offering in the amount of $275 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 10,000,000 Price\Range: $27.5 Discount Per Security: $1.65

Certain Common Stock of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021.

2021-07-20 00:00:00

Certain Common Stock of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021. These Common Stock will be under lockup for 91 days starting from 20-JUL-2021 to 19-OCT-2021. Details: The directors and executive officers have entered into lock-up agreements with the underwriters prior to the commencement of this offering pursuant to which each lock-up party, with limited exceptions, for a period of 90 days after the date of this prospectus, may not (and may not cause any of their direct or indirect affiliates to), without the prior written consent of J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC, offer, sell, assign, transfer, lend, pledge, contract to sell, or otherwise dispose of, or announce the intention to otherwise dispose of, any shares of its common stock or any securities convertible into or exercisable or exchangeable for its common stock (including, without limitation, common stock or such other securities which may be deemed to be beneficially owned by such lock-up parties in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a stock option or warrant (collectively with the common stock, the “lock-up securities”)), enter into any swap, hedge or similar agreement or arrangement that transfers in whole or in part the economic risk of ownership of the lock-up securities, or engage in any short selling of its common stock or securities convertible into or exercisable or exchangeable for its common stock.

Certain Warrants of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021.

2021-07-20 00:00:00

Certain Warrants of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021. These Warrants will be under lockup for 91 days starting from 20-JUL-2021 to 19-OCT-2021. Details: The directors and executive officers have entered into lock-up agreements with the underwriters prior to the commencement of this offering pursuant to which each lock-up party, with limited exceptions, for a period of 90 days after the date of this prospectus, may not (and may not cause any of their direct or indirect affiliates to), without the prior written consent of J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC, offer, sell, assign, transfer, lend, pledge, contract to sell, or otherwise dispose of, or announce the intention to otherwise dispose of, any shares of its common stock or any securities convertible into or exercisable or exchangeable for its common stock (including, without limitation, common stock or such other securities which may be deemed to be beneficially owned by such lock-up parties in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a stock option or warrant (collectively with the common stock, the “lock-up securities”)), enter into any swap, hedge or similar agreement or arrangement that transfers in whole or in part the economic risk of ownership of the lock-up securities, or engage in any short selling of its common stock or securities convertible into or exercisable or exchangeable for its common stock.

Certain Options of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021.

2021-07-20 00:00:00

Certain Options of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021. These Options will be under lockup for 91 days starting from 20-JUL-2021 to 19-OCT-2021. Details: The directors and executive officers have entered into lock-up agreements with the underwriters prior to the commencement of this offering pursuant to which each lock-up party, with limited exceptions, for a period of 90 days after the date of this prospectus, may not (and may not cause any of their direct or indirect affiliates to), without the prior written consent of J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC, offer, sell, assign, transfer, lend, pledge, contract to sell, or otherwise dispose of, or announce the intention to otherwise dispose of, any shares of its common stock or any securities convertible into or exercisable or exchangeable for its common stock (including, without limitation, common stock or such other securities which may be deemed to be beneficially owned by such lock-up parties in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a stock option or warrant (collectively with the common stock, the “lock-up securities”)), enter into any swap, hedge or similar agreement or arrangement that transfers in whole or in part the economic risk of ownership of the lock-up securities, or engage in any short selling of its common stock or securities convertible into or exercisable or exchangeable for its common stock.

Certain Restricted Stock Units of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021.

2021-07-20 00:00:00

Certain Restricted Stock Units of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021. These Restricted Stock Units will be under lockup for 91 days starting from 20-JUL-2021 to 19-OCT-2021. Details: The directors and executive officers have entered into lock-up agreements with the underwriters prior to the commencement of this offering pursuant to which each lock-up party, with limited exceptions, for a period of 90 days after the date of this prospectus, may not (and may not cause any of their direct or indirect affiliates to), without the prior written consent of J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC, offer, sell, assign, transfer, lend, pledge, contract to sell, or otherwise dispose of, or announce the intention to otherwise dispose of, any shares of its common stock or any securities convertible into or exercisable or exchangeable for its common stock (including, without limitation, common stock or such other securities which may be deemed to be beneficially owned by such lock-up parties in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a stock option or warrant (collectively with the common stock, the “lock-up securities”)), enter into any swap, hedge or similar agreement or arrangement that transfers in whole or in part the economic risk of ownership of the lock-up securities, or engage in any short selling of its common stock or securities convertible into or exercisable or exchangeable for its common stock.

Certain Performance Stock Units of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021.

2021-07-20 00:00:00

Certain Performance Stock Units of Cytokinetics, Incorporated are subject to a Lock-Up Agreement Ending on 19-OCT-2021. These Performance Stock Units will be under lockup for 91 days starting from 20-JUL-2021 to 19-OCT-2021. Details: The directors and executive officers have entered into lock-up agreements with the underwriters prior to the commencement of this offering pursuant to which each lock-up party, with limited exceptions, for a period of 90 days after the date of this prospectus, may not (and may not cause any of their direct or indirect affiliates to), without the prior written consent of J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC, offer, sell, assign, transfer, lend, pledge, contract to sell, or otherwise dispose of, or announce the intention to otherwise dispose of, any shares of its common stock or any securities convertible into or exercisable or exchangeable for its common stock (including, without limitation, common stock or such other securities which may be deemed to be beneficially owned by such lock-up parties in accordance with the rules and regulations of the SEC and securities which may be issued upon exercise of a stock option or warrant (collectively with the common stock, the “lock-up securities”)), enter into any swap, hedge or similar agreement or arrangement that transfers in whole or in part the economic risk of ownership of the lock-up securities, or engage in any short selling of its common stock or securities convertible into or exercisable or exchangeable for its common stock.

Cytokinetics, Incorporated Announces Positive Topline Results from Cohorts 1 and 2 of REDWOOD-HCM

2021-07-19 11:36:00

Cytokinetics, Incorporated announced positive topline results from Cohorts 1 and 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of CK-3773274 (CK-274), an investigational next-generation cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy (HCM). The results of REDWOOD-HCM inform dose selection and support progression of CK-274 to a planned Phase 3 registrational clinical trial which is expected to start before year end. Results from Cohorts 1 and 2 of REDWOOD-HCM demonstrated that treatment with CK-274 for 10 weeks resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricular outflow tract pressure gradient (LVOT-G) (p=0.0003, p=0.0004, Cohort 1 and Cohort 2, respectively) and the average post-Valsalva LVOT-G (p=0.001, p<0.0001, Cohort 1 and Cohort 2, respectively). The majority of patients treated with CK-274 (78.6% in Cohort 1 and 92.9% in Cohort 2) achieved the target goal of treatment, defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg at Week 10 compared to placebo (7.7%). Reductions in LVOT-G occurred within two weeks of initiating treatment with CK-274, were maximized within two to six weeks of the start of dose titration, and were sustained until the end of treatment at 10 weeks. The observed reductions in LVOT-G were dose dependent, with patients achieving greater reductions of LVOT-G with increasing doses of CK-274. Treatment with CK-274 in REDWOOD-HCM was generally well tolerated. The incidence of adverse events was similar between treatment arms. No serious adverse events were attributed to CK-274 and no treatment interruptions occurred on CK-274. No new cases of atrial fibrillation in patients treated with CK-274 were reported. In this dose-range finding trial, one patient experienced a transient decrease in left ventricular ejection fraction (LVEF) that required dose adjustment but not dose interruption. LVEF returned to baseline within two weeks after the end of treatment in both cohorts, which was consistent with the reversibility of LVEF decreases that were similarly observed in healthy participants in the Phase 1 study of CK-274. REDWOOD-HCM is a multi-center, randomized, placebo-controlled, double-blind, dose finding clinical trial of CK-274 in patients with symptomatic obstructive HCM (oHCM) on background medical therapy. The primary objective of the trial is to determine the safety and tolerability of CK-274. The secondary objectives are to describe the concentration-response relationship of CK-274 on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment, to describe the dose response relationship of CK-274, and to evaluate the plasma concentrations of CK-274 in patients with oHCM. Seventeen investigative sites in North America and Europe screened for patients to enroll in Cohort 1 and 2 of REDWOOD-HCM. Topline results from REDWOOD-HCM include data from two sequentially conducted cohorts, Cohort 1 (n=21) and Cohort 2 (n=20) which randomized treatment of patients 2:1 to CK-274 or placebo. Patients received up to three escalating doses of CK-274 once daily (5, 10, 15 mg in Cohort 1 and 10, 20, 30 mg in Cohort 2) or placebo. Patients had an echocardiogram after two weeks of treatment at each dose to determine potential up-titration to the next higher dose. Overall, treatment duration for each patient in REDWOOD-HCM was 10 weeks with an echocardiogram conducted 2 weeks after the last dose. For patients on CK-274 in Cohort 1 (n=14), the average resting LVOT-G changed from 53.8 mmHg at baseline to 13.4 mmHg at 10 weeks; for patients on CK-274 in Cohort 2 (n=14) the average resting LVOT-G changed from 58.2 mmHg at baseline to 15.1 mmHg at 10 weeks; and for patients in the combined placebo group (n=13) the average resting LVOT-G changed from 52.1 at baseline to 44.0 mmHg at 10 weeks (Figure 1, p=0.0003 for Cohort 1, p=0.0004 for Cohort 2 in comparison to placebo at 10 weeks). For patients on CK-274 in Cohort 1 (n=14) the average Valsalva LVOT-G changed from 74.4 mmHg at baseline to 38.1 mmHg at 10 weeks; for patients on CK-274 in Cohort 2 (n=14) the average Valsalva LVOT-G changed from 82.3 mmHg at baseline to 29.8 mmHg at 10 weeks; and for patients in the combined placebo group (n=13) the average Valsalva LVOT-G changed from 84.6 at baseline to 76.0 mmHg at 10 weeks (Figure 2; p=0.001 for Cohort 1, p<0.0001 for Cohort 2 in comparison to placebo at 10 weeks). The average ejection fraction for patients on CK-274 in Cohort 1 (n=14) changed from 73.2% at baseline to 67.4% at 10 weeks; for patients on CK-274 in Cohort 2 (n=14) the average ejection fraction changed from 75.4% at baseline to 64.1% at 10 weeks, and for patients in the combined placebo group (n=13) the average ejection fraction changed from 74.5% at baseline to 74.9% at 10 weeks (p=0.007 for Cohort 1, p=<0.0001 for Cohort 2 in comparison to placebo at 10 weeks). Overall, the incidence of adverse events was similar between treatment arms. Treatment with CK-274 in REDWOOD-HCM was generally well tolerated in patients being treated with current standard of care with adverse events reported as mild or moderate in severity. There were no treatment related serious adverse events reported by investigators. No patients who received CK-274 in Cohort 1 had an LVEF <50%. In Cohort 2, one patient with an LVEF at baseline of 58% was up-titrated to 20 mg of CK-274 and experienced transient LVEF reduction to <50% (remaining above 40%) requiring down titration. No interruptions or discontinuations of treatment with CK-274 occurred in any patients across both cohorts. The distribution (Table 1) of patients across doses of CK-274 in REDWOOD-HCM informs dose selection for the planned Phase 3 trial with the objective to assess clinical outcomes at the lowest effective individualized dose of CK-274.

Cytokinetics, Incorporated - Special Call

2021-07-19 11:30:00

To discuss the results of REDWOOD-HCM

Cytokinetics, Incorporated has filed a Follow-on Equity Offering in the amount of $200 million.

2021-07-19 00:00:00

Cytokinetics, Incorporated has filed a Follow-on Equity Offering in the amount of $200 million. Security Name: Common Stock Security Type: Common Stock

Cytokinetics, Incorporated Announces Additional Results From GALACTIC-HF Presented at the European Society of Cardiology Heart Failure 2021

2021-06-30 11:30:00

Cytokinetics, Incorporated announced that additional results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) were presented at Heart Failure 2021, an International Congress of the European Society of Cardiology, including a prespecified subgroup analysis of the influence of atrial fibrillation or flutter (AFF) on the treatment effect of omecamtiv mecarbil in a Late Breaking Clinical Trial Session. Other analyses were presented in the Clinical Trial Updates Session related to which patients in GALACTIC-HF achieved an increased treatment effect with omecamtiv mecarbil. GALACTIC-HF: Patients Without Atrial Fibrillation or Flutter Have Increased Treatment Effect with Omecamtiv Mecarbil: Scott Solomon, M.D., the Edward D. Frohlich Distinguished Chair, Professor of Medicine, Harvard Medical School and Director of Noninvasive Cardiology, Brigham and Women's Hospital, presented additional analyses from GALACTIC-HF assessing how baseline AFF in patients impacted the effectiveness of omecamtiv mecarbil in GALACTIC-HF. Of the 8,256 patients enrolled in GALACTIC-HF, 2,245 patients (27%) had AFF at baseline; these patients were older, more likely to be randomized as inpatients, had a higher New York Heart Association (NYHA) class and had higher NT-proBNP compared to patients without AFF. The effect of treatment with omecamtiv mecarbil on the primary composite endpoint of heart failure events (heart failure hospitalization and other urgent treatment for heart failure) or cardiovascular (CV) death was greater in patients without baseline AFF compared to those patients with AFF at baseline (interaction p=0.012). Importantly, the modification of the treatment effect by AFF was concentrated in patients with AFF using digoxin (n=692) with minimal evidence of effect modification in patients with AFF not using digoxin (n=1553). Digoxin did not modify the treatment effect of omecamtiv mecarbil in patients without AFF. These findings suggest caution should be exercised when treating patients with AFF using both digoxin and omecamtiv mecarbil. Interestingly, given prior observations of the positive impact of omecamtiv mecarbil on left atrial function, an exploratory analysis from GALACTIC-HF indicated fewer serious adverse events of atrial fibrillation in patients without AFF at baseline in patients treated with omecamtiv mecarbil compared to placebo (55 events in 2,974 patients treated with omecamtiv mecarbil vs. 78 events in 3,013 patients treated with placebo, p=0.046). GALACTIC-HF: Patients with Higher Baseline NT-proBNP Have Increased Treatment Effect with Omecamtiv Mecarbil: In a separate analysis, John McMurray, M.D., Professor of Medical Cardiology & Honorary Consultant Cardiologist, Institute of Cardiovascular & Medical Sciences, BHF Cardiovascular Research Centre, University of Glasgow, presented analyses on the effect of treatment with omecamtiv mecarbil according to baseline NT-proBNP in patients without AFF, as well as in all patients in GALACTIC-HF. NT-proBNP is a biomarker of ventricular wall stress in which higher levels reflect more severe heart failure. Among the 5,971 patients who did not have AFF, the median (Q1, Q3) NT-proBNP level was 1,675 (812-3579 pg/ml). In patients without AFF, the treatment effect of omecamtiv mecarbil on the primary composite endpoint was increased in patients with a baseline NT-proBNP above the median (hazard ratio, 0.81; 95% confidence interval 0.73-0.90) compared to patients with baseline NT-proBNP equal to or below the median (HR, 0.94; 95% CI 0.80-1.09; interaction p=0.095). The same pattern was observed in the overall population in which patients with a baseline NT-proBNP greater than the median experienced an increased treatment effect (HR, 0.88; 95% CI 0.80-0.96) compared to patients with a baseline NT-proBNP equal to or below the median (HR, 1.01; 95% CI 0.90-1.15; interaction p=0.035.) Examined as a continuous variable, there was an interaction between treatment with omecamtiv mecarbil and baseline NT-proBNP that showed an increased treatment effect on the primary outcome in patients as baseline NT-proBNP increased both in those without AFF (interaction p=0.024) and in the overall population (interaction p=0.005). These findings suggest the benefit of treatment with omecamtiv mecarbil increased progressively as baseline NT-proBNP increased consistent with other analyses from GALACTIC-HF that suggest more severe heart failure patients may derive increased benefit from treatment with omecamtiv mecarbil. GALACTIC-HF: Patients with Severe Heart Failure Have Increased Treatment Effect with Omecamtiv Mecarbil: Michael Felker, M.D., Professor of Medicine, Duke Clinical Research Institute presented an analysis of the treatment effect of omecamtiv mecarbil on the primary composite endpoint in patients from GALACTIC-HF classified as having severe heart failure based on modified criteria from the Heart Failure Association of the European Society of Cardiology (ESC-HFA) advanced heart failure position statement. Patients in this subgroup had NYHA class III-IV symptoms, EF = 30%, and hospitalization for heart failure within the prior six months. Of patients enrolled in GALACTIC-HF, 2,258 (27%) met these criteria for severe heart failure. Patients with severe heart failure had markers of more advanced disease and higher baseline risk, with event rates in patients treated with placebo that were approximately twice those of patients without severe heart failure. In patients with severe heart failure, the treatment effect of omecamtiv mecarbil on the primary composite endpoint was increased (HR, 0.80; 95% CI 0.71-0.90) compared to patients without severe heart failure (HR, 0.99; 95% CI 0.91-1.08; interaction p=0.005). The results for CV death were qualitatively similar; patients with severe heart failure experienced a trend towards treatment benefit from omecamtiv mecarbil (HR, 0.88; 95% CI 0.75-1.03) while patients without severe heart failure did not (HR, 1.10, 95% CI 0.97-1.25; interaction p=0.028). Furthermore, as the severity of heart failure increased, as indicated by the number of the three severity criteria met, both the incidence of the primary composite endpoint and the treatment effect of omecamtiv mecarbil increased. Omecamtiv mecarbil was equally well tolerated in patients with and without severe heart failure, with no significant changes in blood pressure, renal function, or potassium compared to placebo. These results from GALACTIC-HF demonstrate a potentially clinically important treatment effect of omecamtiv mecarbil in patients with severe heart failure.