Disopyramide

Cytokinetics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Thursday, November 2, 2023
Randomness, FDA, National Medical Products Administration, Standard of care, Research, Heart failure, Manuscript, American College, NMPA, Food, Center for Drug Evaluation and Research, Pivotal, LVEF, OND, Symantec Endpoint Protection, Safety, Cytokinetics, Organization, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Journal of Cardiac Failure, Obstruction, SAD, Journal, Cardiology, CRL, Disopyramide, ALS, Clinical trial, CDE, EMA, Șaeș, Assessment, NDA, Investment, LVOT, Plasma protein binding, Pharmaceutical industry, Medical device, Patient, Pharmacokinetics, Pharmacology, HCM, EU

SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023. Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share. Cash, cash equivalents and investments totaled $554.7 million on September 30, 2023.

Key Points: 
  • On Track for Topline Results from SEQUOIA-HCM,
    a Pivotal Phase 3 Clinical Trial of Aficamten in Obstructive HCM,
    the Open-Label Extension Study of Aficamten,
    SOUTH SAN FRANCISCO, Calif., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the third quarter of 2023.
  • Net loss for the third quarter was $129.4 million, or $1.35 per share, compared to net loss for the third quarter of 2022 of $142.3 million, or $1.52 per share.
  • “During the third quarter we made considerable progress across our specialty cardiology franchise, with aficamten remaining our top priority.
  • During the quarter we also started ACACIA-HCM, a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM.

Cytokinetics Presents Baseline Characteristics From SEQUOIA-HCM at the HCM Society Scientific Sessions

Retrieved on: 
Friday, October 6, 2023
III, Research and development, Guideline, Calcium channel, Female, Disopyramide, VO2, N-terminal prohormone of brain natriuretic peptide, Obstruction, SD, LVEF, NYHA, Safety, Exercise, Patient, SAN, Cytokinetics, Medical Center, LVOT, Lahey Hospital & Medical Center, Pharmaceutical industry, HCM

SEQUOIA-HCM enrolled a total of 282 patients, with one third from the United States, one half from Europe and Israel, and the remainder from China.

Key Points: 
  • SEQUOIA-HCM enrolled a total of 282 patients, with one third from the United States, one half from Europe and Israel, and the remainder from China.
  • Background medical therapy consisted of beta-blockers (61%), calcium channel blockers (26.6%), and disopyramide (12.8%); combination background therapy was permitted.
  • At baseline, 75.9% of patients were NYHA functional class II, 23.8% were functional class III, and 0.4% were functional class IV.
  • Key baseline characteristics that remain blinded include left ventricular ejection fraction (LVEF), resting and Valsalva LVOT-G, and NT-proBNP.

Cytokinetics Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 3, 2023
CSS, NYHA, Heart failure, Clinical study design, Symantec Endpoint Protection, Cohort, Safety, Food, Library classification, Completeness, Metoprolol, Journal of Cardiac Failure, KCCQ, New York Heart Association Functional Classification, Journal, Cytokinetics, Investment, Manuscript, Disopyramide, Obstruction, Assessment, Pivotal, CRL, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry, Medical imaging, Patient, HCM

SOUTH SAN FRANCISCO, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the second quarter of 2023. Net loss for the second quarter was $128.6 million, or $1.34 per share, compared to net loss for the second quarter of 2022 of $19.8 million, or $0.23 per share. Cash, cash equivalents and investments totaled $592.6 million at June 30, 2023.

Key Points: 
  • Completed Enrollment in SEQUOIA-HCM, Pivotal Phase 3 Trial of Aficamten in Obstructive HCM; On Track for Topline Results by the End of the Year
    ACACIA-HCM, a Pivotal Phase 3 Clinical Trial of Aficamten in Non-Obstructive HCM, Expected to Start in September 2023
    SOUTH SAN FRANCISCO, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the second quarter of 2023.
  • Net loss for the second quarter was $128.6 million, or $1.34 per share, compared to net loss for the second quarter of 2022 of $19.8 million, or $0.23 per share.
  • Cash, cash equivalents and investments totaled $592.6 million at June 30, 2023.
  • We are pleased with ongoing study conduct and expect topline results from SEQUOIA-HCM by year end,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer.

Cytokinetics Presents New Data From REDWOOD-HCM OLE in Late Breaking Clinical Trial Session at the HCM Society Scientific Sessions

Retrieved on: 
Friday, September 30, 2022
The Act, Muscle tissue, Hypertrophic cardiomyopathy, Blood, Safe harbor, Cytokinetics, Cardiac muscle, Breakthrough therapy, Patient, U.S. Securities and Exchange Commission, Exercise, Therapeutic index, Pharmacology, ALS, Research, Disease, Death, Multisystemic smooth muscle dysfunction syndrome, Research and development, Sale, Intellectual property, NDA, Heart failure, History, SAN, NYHA, Patent, YouTube, Dizziness, Mechanics, Chest pain, FDA, Security (finance), HCM, GLOBE, Act, Twitter, N-terminal prohormone of brain natriuretic peptide, Muscle weakness, Cohort, LinkedIn, Arrhythmia, Private Securities Litigation Reform Act, Stroke, Facebook, Clinical study design, Disopyramide, Atrial fibrillation, Recurrence, Pharmaceutical industry, MD

Cytokinetics is also developing aficamten, a next-generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM).

Key Points: 
  • Cytokinetics is also developing aficamten, a next-generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM).
  • Cytokinetics expects to start a Phase 3 clinical trial of aficamten in patients with obstructive HCM in Q4 2021.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Cytokinetics Announces Additional Data From REDWOOD-HCM Presented at the American Society of Echocardiography 33rd Annual Scientific Sessions

Retrieved on: 
Monday, June 13, 2022
Exercise, Cohort, Disease, Disopyramide, Breakthrough therapy, Therapeutic index, Adrenal insufficiency, Clinical study design, FDA, Patient, Research and development, Left ventricular hypertrophy, Clinical trial, Oxford Handbook of Clinical Medicine, Hypertrophic cardiomyopathy, Pharmaceutical industry, HCM

SOUTH SAN FRANCISCO, Calif., June 13, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today 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.

Key Points: 
  • Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic obstructive HCM from the U.S. Food & Drug Administration (FDA).
  • Patients treated with aficamten also saw improvements in heart failure symptoms and reductions in NT-proBNP, a biomarker of cardiac wall stress.
  • 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.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.

Cytokinetics Reports First Quarter 2022 Financial Results

Retrieved on: 
Wednesday, May 4, 2022
Buildout, Investment, American College, Efficacy, European Heart Journal, Disopyramide, GLOBE, NDA, Heart failure, Safety, Food, Open-label trial, Blood, Clinical study design, Patient, Royalty Pharma, Heart, FDA, Cohort, Rationale, New Drug Application, CPET, Manuscript, Cardiology, Lists of scientists, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Atrial fibrillation, Cytokinetics, PDUFA, Risk, Exercise, Medical device, Pharmaceutical industry, HCM

SOUTH SAN FRANCISCO, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2022. Net loss for the first quarter was $89.4 million, or $1.05 per share, compared to net loss for the first quarter of 2021 of $47.1 million, or $0.66 per share. Cash, cash equivalents and investments totaled $686.1 million at March 31, 2022.

Key Points: 
  • Initial Data from REDWOOD-HCM OLE, the Open Label Extension Study of Aficamten, to be Presented at Heart Failure 2022 on May 23, 2022
    Continued Launch Readiness Activities and Buildout of Commercial Infrastructure in Advance of PDUFA Date of November 30, 2022 for Omecamtiv Mecarbil
    SOUTH SAN FRANCISCO, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2022.
  • Revenues for the first quarter 2022 were $1.1 million compared to $6.5 million for the corresponding period in 2021.
  • Members of Cytokinetics senior management team will review the companys first quarter results on a conference call today at 4:30 PM Eastern Time.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

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

Retrieved on: 
Saturday, April 2, 2022
Blood pressure, Clinical trial, University of Pennsylvania, Patient, Disopyramide, SD, Moderation, Assistant, Clinical study design, Week, Cohort, Center, Safety, Valsalva maneuver, American College, Cardiology, Heart rate, LVOT, GLOBE, Cytokinetics, LVEF, Oxford Handbook of Clinical Medicine, SAN, Obstruction, Research and development, Mercury (element), University, Pharmaceutical industry, NYHA, HCM

All patients received up to three escalating doses of aficamten once daily (5, 10, 15 mg), titrated based on echocardiographic guidance.

Key Points: 
  • 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.
  • For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Cytokinetics Announces Cohort 4 of REDWOOD-HCM Is Open to Enrollment

Retrieved on: 
Wednesday, March 2, 2022
Patient, Hypertrophic cardiomyopathy, Disopyramide, Cohort, N-terminal prohormone of brain natriuretic peptide, Safety, SAN, Â, Cytokinetics, Clinical trial, LVEF, LVOT, GLOBE, Clinical study design, Research and development, Pharmaceutical industry, HCM

REDWOOD-HCM is a Phase 2, multi-center, randomized, placebo-controlled, double-blind, dose finding clinical trial of aficamten in patients with HCM.

Key Points: 
  • REDWOOD-HCM is a Phase 2, multi-center, randomized, placebo-controlled, double-blind, dose finding clinical trial of aficamten in patients with HCM.
  • Cohorts 1 and 2 enrolled patients with symptomatic obstructive HCM taking background medications exclusive of disopyramide while Cohort 3 enrolled patients taking background medications including disopyramide.
  • Cohort 4 will enroll, in an open label fashion, 30-40 patients with symptomatic non-obstructive HCM receiving background medical therapy.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

Cytokinetics Reports Fourth Quarter 2021 Financial Results

Retrieved on: 
Thursday, February 24, 2022
GLOBE, Risk, Mercury (element), Blood, File, Cohort, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, American Heart Association, New Drug Application, HF, Investment, American College, Heart, Clinical study design, AHA, Stroke, Cardiology, CPET, Heart failure, Food, Exercise, Obstruction, PDUFA, Safety, FDA, Medical Scientist Training Program, Cytokinetics, Patient, Â, NDA, Disopyramide, Pharmaceutical industry, HCM

SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2021. Net loss for the fourth quarter was $30.6 million or $0.36 per share and the net loss for the year 2021 was $215.3 million or $2.80 per share. Net loss for the fourth quarter of 2020 was $43.9 million or $0.62 per share and net loss for the year 2020 was $127.3 million or $1.97 per share. Cash, cash equivalents and investments totaled $623.7 million at December 31, 2021. This cash balance does not include $150 million in proceeds received from transactions executed in late 2021 and early 2022.

Key Points: 
  • Commercial Launch Readiness Activities Underway for Omecamtiv Mecarbil in Advance of PDUFA Date of November 30, 2022
    Company Provides 2022 Financial Guidance;
    SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2021.
  • Members of Cytokinetics senior management team will review the companys fourth quarter results on a conference call today at4:30 PM Eastern Time.
  • For further information regarding these and other risks related to Cytokinetics business, investors should consult Cytokinetics filings with the Securities and Exchange Commission, particularly under the caption Risk Factors in Cytokinetics Quarterly Report on Form 10-Q for the third quarter 2021.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

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

Retrieved on: 
Tuesday, February 1, 2022
Clinical study design, Hypertrophic cardiomyopathy, Cytokinetics, Mercury (element), Patient, Cohort, SAN, GLOBE, Disopyramide, Pharmaceutical industry, HCM

SOUTH SAN FRANCISCO, Calif., Feb. 01, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today 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).

Key Points: 
  • New York Heart Association functional class was improved in the majority of patients participating in Cohort 3 of the trial.
  • 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.
  • We look forward to initiating screening of patients in SEQUOIA-HCM soon and look forward to sharing these results from Cohort 3 with the medical community in April.
  • CYTOKINETICS and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.