This section highlights FDA-related milestones and regulatory updates for drugs developed by Cytokinetics (CYTK).
Over the past two years, Cytokinetics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Aficamten, CK-4021586, CK-586, and omecamtiv. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Aficamten - FDA Regulatory Timeline and Events
Aficamten is a drug developed by Cytokinetics for the following indication: Symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Aficamten
- Announced Date:
- May 18, 2025
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced that additional data arising from two analyses from SEQUOIA-HCM, (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), and results from a real-world analysis related to non-obstructive HCM were presented at the European Society of Cardiology Heart Failure 2025 Congress.
AI Summary
Cytokinetics, Incorporated announced that additional data from two analyses of the SEQUOIA-HCM Phase 3 trial were presented at the European Society of Cardiology Heart Failure 2025 Congress. The trial evaluated aficamten, an investigational drug intended for patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). The analyses demonstrated that aficamten’s impact on exercise capacity, symptoms, hemodynamics, and cardiac biomarkers was consistent regardless of patients’ baseline symptom severity and geographic region. In addition, a real-world analysis of non-obstructive HCM revealed significant differences in outcomes, indicating that females and older patients experienced higher rates of adverse cardiovascular events. These insights provide valuable information on how patient subgroups may respond to aficamten and support ongoing research into personalized treatment strategies for HCM.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- May 1, 2025
- Estimated Event Date Range:
- December 26, 2025 - December 26, 2025
- Target Action Date:
- December 26, 2025
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025.
AI Summary
Cytokinetics, Incorporated announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for its New Drug Application (NDA) for aficamten, a treatment for obstructive hypertrophic cardiomyopathy (oHCM), to December 26, 2025. This extension comes after the FDA requested additional time to conduct a complete review of Cytokinetics' proposed Risk Evaluation and Mitigation Strategy (REMS). The company submitted the REMS following the agency's request, and this submission has been classified as a Major Amendment, resulting in an extra three-month extension of the original timeline. Cytokinetics remains confident in aficamten’s benefit-risk profile and anticipates a differentiated approval that includes a supportive label and effective risk management measures to ensure patient safety.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- December 23, 2024
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM).
AI Summary
Cytokinetics, Incorporated announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for aficamten, a next-in-class cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (HCM). This milestone means that the application will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). Aficamten is designed to target hypercontractility in the heart by reducing the number of active actin-myosin cross bridges during each cardiac cycle, which may help lessen symptoms and improve exercise capacity in patients with HCM. The validation of the MAA by the EMA is a key step in Cytokinetics’ mission to bring a new treatment option to more patients affected by this serious heart condition.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- December 2, 2024
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced that the U.S. Food & Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM).
AI Summary
Cytokinetics, Incorporated announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor designed to treat obstructive hypertrophic cardiomyopathy (HCM). The acceptance of the NDA marks a significant milestone in the company’s efforts to bring new treatment options to patients with obstructive HCM. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2025, for completing its review of the application.
The decision follows positive results from the pivotal Phase 3 SEQUOIA-HCM clinical trial, which demonstrated that aficamten can improve exercise capacity, reduce symptom burden, and positively impact cardiac biomarkers with a favorable safety profile. Cytokinetics believes that if approved, aficamten may soon become a preferred choice among physicians and patients, further advancing treatment in the field of cardiology.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- December 2, 2024
- Estimated Event Date Range:
- September 26, 2025 - September 26, 2025
- Target Action Date:
- September 26, 2025
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced that PDUFA Target Action Date Set for September 26, 2025
AI Summary
Cytokinetics, Incorporated announced that the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2025, for its New Drug Application for aficamten. This next-in-class cardiac myosin inhibitor is under review for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The FDA accepted the application for a standard review, marking a significant milestone for Cytokinetics. The submission is supported by positive data from the SEQUOIA-HCM Phase 3 clinical trial. In this study, aficamten showed improvements in exercise capacity, symptoms, and cardiac biomarkers in patients with HCM. If approved, the drug could provide a new treatment option for patients, potentially becoming a preferred choice among physicians. This target action date highlights the regulatory progress and ongoing efforts to bring innovative therapies to those suffering from heart conditions.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- November 16, 2024
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced new data relating to aficamten and hypertrophic cardiomyopathy (HCM), were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL.
AI Summary
Cytokinetics, Incorporated presented new data on aficamten at the American Heart Association Scientific Sessions 2024 in Chicago, IL. The findings build on previous successful studies, including positive results from the Phase 3 SEQUOIA-HCM trial, which evaluated aficamten in patients with obstructive hypertrophic cardiomyopathy (HCM).
Following these promising results, Cytokinetics has submitted a New Drug Application to the FDA for aficamten and is moving forward with regulatory efforts in Europe. The company is also progressing several Phase 3 clinical trials to further assess the potential of aficamten across diverse groups. These include MAPLE-HCM comparing aficamten to metoprolol in obstructive HCM, ACACIA-HCM for patients with non-obstructive HCM, CEDAR-HCM in pediatric patients, and FOREST-HCM as an open-label extension study. The new data aims to support aficamten’s role in improving heart muscle function and reducing HCM symptoms.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- September 30, 2024
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced that additional analyses synthesizing data from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), were presented virtually at the Heart Failure Society of America (HFSA) Annual Scientific Meeting by Martin Maron, M.D., Director of the Hypertrophic Cardiomyopathy Center at the Lahey Hospital and Medical Center.
AI Summary
Cytokinetics, Inc. announced new analyses from the pivotal Phase 3 SEQUOIA-HCM trial, which studied aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). The additional data were presented virtually at the Heart Failure Society of America Annual Scientific Meeting by Martin Maron, M.D., Director of the Hypertrophic Cardiomyopathy Center at Lahey Hospital and Medical Center. His presentation, published simultaneously in the Journal of the American College of Cardiology, highlighted improvements on several key clinical measures. These measures included a complete hemodynamic response, relief of symptoms, enhanced exercise capacity, and a significant reduction in cardiac biomarkers after 24 weeks of treatment. The findings demonstrated that aficamten led to markedly better outcomes compared to placebo, providing important insights to support its role as a next-in-class treatment option for patients with obstructive HCM.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- September 27, 2024
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced that additional data from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), were presented at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions by Anjali T. Owens, M.D., Medical Director of the Center for Inherited Cardiac Disease and Assistant Professor of Medicine at the University of Pennsylvania.
AI Summary
Cytokinetics, Incorporated announced that new data from the SEQUOIA-HCM Phase 3 trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) was recently presented. The pivotal study, named SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), is designed to evaluate both the clinical and functional outcomes of the treatment. Anjali T. Owens, M.D., Medical Director of the Center for Inherited Cardiac Disease at the University of Pennsylvania, shared the findings during the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions. This new analysis highlights beneficial changes across several measures of cardiac structure, electrophysiology, and biomarkers in patients treated with aficamten compared to placebo. The results underline improvements in key indices used to assess remodeling of the heart—a promising sign for patients with obstructive HCM.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- September 1, 2024
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced that additional data from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), related to cardiac remodeling and improvements in patient symptoms, cardiac structure, function and biomarkers, were presented in three Late Breaking Clinical Trial presentations and one oral presentation at the European Society of Cardiology Congress 2024 in London, UK.
AI Summary
Cytokinetics, Incorporated announced new findings from the pivotal SEQUOIA-HCM Phase 3 clinical trial at the European Society of Cardiology Congress 2024 in London, UK. The additional data were shared through three Late Breaking Clinical Trial presentations and one oral presentation, and they focused on how aficamten affects cardiac remodeling in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). This trial data highlighted improvements in patient symptoms, cardiac structure, function, and key biomarkers. The results suggest that aficamten, a selective cardiac myosin inhibitor, may offer a potential advantage in treating obstructive HCM by enhancing overall cardiac performance and possibly simplifying patients’ treatment regimens. Cytokinetics emphasized that these insights further support the promise of aficamten in addressing the challenges associated with obstructive HCM and improving patients’ quality of life.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- June 17, 2024
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced that the first participants have been dosed in a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants.
AI Summary
Cytokinetics, Incorporated has begun dosing the first participants in its Phase 1 clinical trial for aficamten. The study focuses on evaluating the drug’s pharmacokinetics, safety, and tolerability in healthy Japanese and Caucasian adults. Researchers are using a double-blind, randomized, placebo-controlled design that includes both single and multiple dose groups. The trial aims to gather essential data on how the drug is absorbed, distributed, and cleared from the body, which is important for ensuring its safety. This study is a critical step in gathering the evidence needed to support future approval in Japan. By enrolling participants from different ethnic backgrounds, Cytokinetics hopes to better understand any variations in drug response. The findings from this Phase 1 trial will contribute to larger clinical development programs and eventual regulatory submissions in the United States and Europe.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- May 8, 2024
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics announced that CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment. Aficamten is a next-in-class cardiac myosin inhibitor in development for the potential treatment of HCM.
AI Summary
Cytokinetics announced that its clinical trial, CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), is now open for enrollment. This study focuses on aficamten, a next-in-class cardiac myosin inhibitor, which is being developed as a potential treatment for hypertrophic cardiomyopathy (HCM). The trial will assess the appropriate dosing of aficamten in pediatric patients who have symptomatic obstructive HCM. By studying how the drug works in reducing cardiac obstruction, researchers aim to determine if aficamten can offer a new treatment approach for younger individuals facing this serious condition. The trial is a significant step toward enhancing treatment options and understanding the effects of the medication, potentially leading to improved management of HCM in a highly vulnerable population.
Read Announcement- Drug:
- Aficamten
- Announced Date:
- April 10, 2024
- Indication:
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
Announcement
Cytokinetics, Incorporated announced three Late Breaking Clinical Trial presentations relating to SEQUOIA-HCM, (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), at Heart Failure 2024, an International Congress of the European Society of Cardiology, taking place in Lisbon, Portugal from May 11, 2024 – May 14, 2024.
AI Summary
Cytokinetics, Incorporated announced that three Late Breaking Clinical Trial presentations from the pivotal SEQUOIA-HCM study will be featured at Heart Failure 2024. The trial evaluates aficamten, a next-in-class cardiac myosin inhibitor, in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). The presentations will cover primary results, the effects of aficamten on exercise capacity, and detailed insights into its dosing and safety profile. Each presentation is led by respected physicians such as Dr. Martin Maron, Dr. Gregory Lewis, and Dr. Caroline Coats, who will share data that elaborates on the positive top-line outcomes from SEQUOIA-HCM.
This important event takes place at the International Congress of the European Society of Cardiology in Lisbon, Portugal from May 11 to May 14, 2024. The results may offer significant insight into potential new treatments for patients with obstructive HCM.
Read Announcement
CK-4021586 - FDA Regulatory Timeline and Events
CK-4021586 is a drug developed by Cytokinetics for the following indication: Novel, selective, oral, small molecule cardiac myosin inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CK-4021586
- Announced Date:
- September 9, 2024
- Indication:
- Novel, selective, oral, small molecule cardiac myosin inhibitor
Announcement
Cytokinetics, Incorporated announced that data from the Phase 1 study of CK-4021586 (CK-586) were presented in a poster session at the American College of Clinical Pharmacology (ACCP) Annual Meeting in Bethesda, MD.
AI Summary
Cytokinetics, Incorporated announced that data from its Phase 1 study of CK‑4021586 (CK‑586) were presented during a poster session at the American College of Clinical Pharmacology (ACCP) Annual Meeting in Bethesda, MD. The study successfully met its primary and secondary goals by showing that CK‑586 is safe, well tolerated, and has predictable pharmacokinetics when given as single and multiple oral doses to healthy participants.
The results confirmed that CK‑586, a cardiac myosin inhibitor, reduces cardiac contractility at the sarcomere level and supports a once‑daily fixed dosing regimen. These positive findings have paved the way for a Phase 2 clinical trial in patients with heart failure with preserved ejection fraction (HFpEF), particularly in individuals with hypercontractility and ventricular hypertrophy. The Phase 2 trial is expected to begin in the fourth quarter of 2024.
Read Announcement- Drug:
- CK-4021586
- Announced Date:
- September 9, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- Novel, selective, oral, small molecule cardiac myosin inhibitor
Announcement
Cytokinetics, Incorporated announced that Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024
AI Summary
Cytokinetics, Incorporated announced that it plans to start a Phase 2 clinical trial in the fourth quarter of 2024. The trial will focus on testing CK-4021586 (CK-586), a novel cardiac myosin inhibitor, in patients with heart failure with preserved ejection fraction (HFpEF). This drug is designed to help a specific group of patients who show signs of hypercontractility and ventricular hypertrophy. Earlier Phase 1 studies in healthy participants showed that CK-586 is safe, well tolerated, and works predictably. The results indicated that the drug lowers cardiac contractility by acting directly at the level of the sarcomere, with a shallow dose-response relationship that supports a once-daily fixed dosing regimen. The upcoming Phase 2 trial will further evaluate the benefits of CK-586 in treating HFpEF, potentially offering a new treatment option for patients who currently have limited therapies.
Read Announcement- Drug:
- CK-4021586
- Announced Date:
- May 8, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- Indication:
- Novel, selective, oral, small molecule cardiac myosin inhibitor
Announcement
Cytokinetics, Incorporated announced that Full Data from the Phase 1 Study to be Presented at a Medical Congress in 2H 2024
AI Summary
Cytokinetics, Incorporated has announced that full data from its Phase 1 study will be presented at a medical congress scheduled for the second half of 2024. This upcoming presentation is a key milestone for the company, as it will provide detailed insights into the study's results.
The data is expected to shed light on the early stages of the drug's potential benefits and offers a closer look at the initial findings. Researchers, clinicians, and industry professionals are particularly interested in how this information might influence future development and regulatory considerations. The presentation at the congress is seen as an opportunity for Cytokinetics to demonstrate progress and build confidence in their ongoing efforts to develop promising treatments.
Read Announcement- Drug:
- CK-4021586
- Announced Date:
- May 8, 2024
- Indication:
- Novel, selective, oral, small molecule cardiac myosin inhibitor
Announcement
Cytokinetics, Incorporated announced topline data from the Phase 1 study of CK-4021586 (CK-586).
AI Summary
Cytokinetics, Incorporated recently announced topline data from its Phase 1 study of CK-4021586 (CK-586). The study aimed to assess the safety and early pharmacologic effects of CK-586, a novel compound developed for possible treatment options. Early indications from the trial suggest that the compound was generally well tolerated, and researchers identified key markers for further investigation. The Phase 1 trial was designed to offer an initial look into the drug’s profile in humans, providing essential information for planning larger clinical studies. These early results help guide the development process, as Cytokinetics moves forward in exploring CK-586’s potential benefits. The company’s announcement reflects continued efforts to bring innovative therapies to market, with the further goal of addressing unmet needs in patient care.
Read Announcement- Drug:
- CK-4021586
- Announced Date:
- May 8, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 - 2024
- Indication:
- Novel, selective, oral, small molecule cardiac myosin inhibitor
Announcement
Cytokinetics, Incorporated announced that Data Support Advancement to Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024
AI Summary
Cytokinetics, Incorporated has announced that new data supports their advancement to a Phase 2 clinical trial. This trial will focus on treating patients with heart failure with preserved ejection fraction, a condition that affects the heart's ability to pump blood effectively. The company plans to begin this study by the fourth quarter of 2024, marking an important step forward in developing new treatments for heart failure.
This move could signal progress in finding better treatment options for patients with this common and challenging condition. With the upcoming clinical trial, Cytokinetics aims to assess the safety and potential benefits of their therapy, which hopes to improve heart function and overall quality of life for those affected. The announcement has drawn interest from the medical community, suggesting that the new trial could be a promising step in combating heart failure.
Read Announcement
CK-586 - FDA Regulatory Timeline and Events
CK-586 is a drug developed by Cytokinetics for the following indication: In Patients With Symptomatic Heart Failure With Preserved Ejection Fraction.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CK-586
- Announced Date:
- January 21, 2025
- Indication:
- In Patients With Symptomatic Heart Failure With Preserved Ejection Fraction
Announcement
Cytokinetics, Incorporated announced that AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF) is open to enrollment.
Read Announcement
omecamtiv mecarbil - FDA Regulatory Timeline and Events
omecamtiv mecarbil is a drug developed by Cytokinetics for the following indication: Novel cardiac muscle activator, patients with heart failure.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- omecamtiv mecarbil
- Announced Date:
- December 3, 2024
- Indication:
- Novel cardiac muscle activator, patients with heart failure
Announcement
Cytokinetics, Incorporated announced that COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure (HF) with severely reduced ejection fraction, is open to enrollment.
Read Announcement
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