Welcome to our dedicated page for Cytokinetics news (Ticker: CYTK), a resource for investors and traders seeking the latest updates and insights on Cytokinetics stock.
Cytokinetics, Incorporated (Nasdaq: CYTK) is a specialty cardiovascular biopharmaceutical company that regularly issues news about its medicines and programs in cardiac muscle dysfunction. Company updates frequently highlight MYQORZO (aficamten), a cardiac myosin inhibitor that Cytokinetics reports is approved in the United States and China for adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms, as well as related regulatory developments in other regions.
News for CYTK often covers key regulatory milestones such as positive opinions from the Committee for Medicinal Products for Human Use of the European Medicines Agency, approvals by national regulatory agencies and progress of New Drug Application reviews. Cytokinetics also reports on clinical trial data from studies like SEQUOIA-HCM and MAPLE-HCM, including results presented at major cardiology congresses and publications in peer-reviewed journals.
Investors and observers can find announcements about the company’s broader pipeline, including omecamtiv mecarbil in heart failure with severely reduced ejection fraction, ulacamten in heart failure with preserved ejection fraction and CK-089 in skeletal muscle disorders. Additional news items describe financial results, capital raising activities, inducement equity grants, executive appointments and participation in healthcare and investor conferences.
This CYTK news page aggregates these disclosures so readers can follow developments in Cytokinetics’ cardiovascular programs, regulatory interactions and corporate activities over time.
Cytokinetics provided updates on its cardiac myosin modulation programs and global commercial launch readiness for aficamten at its Investor and Analyst Day. Key highlights include:
1. NDA submission for aficamten to FDA in Q3 2024
2. COMET-HF, a confirmatory Phase 3 trial of omecamtiv mecarbil, expected to begin in Q4 2024
3. AMBER-HFpEF, a Phase 2 trial of CK-586, also set to start in Q4 2024
4. Global commercial launch preparations underway for aficamten's potential approval in 2025
5. Launch of unbranded disease awareness campaign "HCM Beyond The Heart" for healthcare professionals
The company is advancing its specialty cardiology franchise focused on myosin modulation to address unmet patient needs in hypertrophic cardiomyopathy (HCM) and heart failure.
Cytokinetics (Nasdaq: CYTK) announced on October 3, 2024, that it granted stock options and restricted stock units (RSUs) to 30 new employees who joined in September 2024. The grants include:
- 88,653 stock options to purchase common stock
- 57,558 RSUs to be settled into common stock upon vesting
The RSUs will vest over 3 years: 40% after year 1, 40% after year 2, and 20% after year 3. The stock options have an exercise price of $52.80 per share and will vest over 4 years: 1/4 after year 1, and 1/48 monthly thereafter. Both are subject to continued employment. These grants were made as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).
Cytokinetics (Nasdaq: CYTK) will host an Investor and Analyst Day on October 16, 2024, from 8:30 AM to 11:30 AM ET at the Nasdaq MarketSite in New York City. The event, titled 'Heart Forward: Advancing Cardiac Myosin Modulation,' will be streamed live online.
The company's leadership and expert clinicians will discuss cardiac myosin modulation programs and opportunities in specialty care cardiovascular markets. A key focus will be the global commercial launch preparations for aficamten, a cardiac myosin inhibitor being developed for obstructive hypertrophic cardiomyopathy (HCM).
Featured expert clinicians include Dr. Mariko Harper, Dr. Shepard D. Weiner, and Dr. G. Michael Felker. Interested parties must register online by October 13, 2024. The webcast replay will be available until April 16, 2025.
Cytokinetics presented additional analyses from the SEQUOIA-HCM Phase 3 trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) at the HFSA Annual Scientific Meeting. The results were also published in the Journal of the American College of Cardiology.
Key findings after 24 weeks of treatment include:
- 68% of aficamten-treated patients showed complete hemodynamic response vs. 7% for placebo
- 71% experienced symptom relief vs. 42% for placebo
- 46.5% showed enhanced exercise capacity vs. 24% for placebo
- 84% demonstrated substantial cardiac biomarker response vs. 8% for placebo
Overall, 97% of aficamten-treated patients achieved one or more clinically relevant outcomes, with 62% achieving at least three outcomes and 23% achieving all four outcomes. The number needed to treat was fewer than 5 patients for each outcome.
Cytokinetics (Nasdaq: CYTK) presented additional data from SEQUOIA-HCM, the Phase 3 trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), at the HCMS Scientific Sessions. The new analysis showed that aficamten treatment was associated with beneficial changes in five indices reflecting structural, electrophysiologic, and biomarker changes compared to placebo at 24 weeks:
- Improvement in maximal wall thickness (47.9% vs 30.7%; p=0.003)
- Improvement in left atrial volume index category (46.8% vs. 18.7%; p<0.001)
- Resolution of ECG changes consistent with left ventricular hypertrophy (19.0% vs. 4.3%; p<0.001)
- Normalization of hyperdynamic left ventricular ejection fraction (35.2% vs 20.7%; p<0.007)
- Reduction in NT-proBNP by ≥50% from baseline (81.7% vs. 7.1%; p<0.001)
Overall, 83.8% of patients treated with aficamten experienced favorable effects in at least one of the five domains, compared to 39.3% of patients on placebo (p<0.001, NNT = 2.2).
Cytokinetics (Nasdaq: CYTK) has announced its seventh annual Communications Grant Program, offering $100,000 in grants to patient advocacy organizations focused on cardiovascular diseases. The program will award five grants of $20,000 each to organizations serving the hypertrophic cardiomyopathy (HCM) and heart failure communities.
The grants aim to support increased communications, awareness building, and community engagement. Eligible organizations must be nonprofits or registered charities in the United States, Canada, Europe, or United Kingdom. The application deadline is November 4th, 2024, with recipients to be announced in January 2025.
The program seeks to bridge the funding gap for communication efforts in nonprofit patient organizations, enabling them to reach broader audiences and connect patients with available resources. Applications can be submitted online, and recipients will be required to provide an outcomes report at the end of the year.
Cytokinetics (Nasdaq: CYTK) announced upcoming presentations at two major cardiology conferences in Atlanta, GA. At the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions on September 27, 2024, three presentations will focus on:
- Global remodeling changes with aficamten in obstructive hypertrophic cardiomyopathy patients
- Efficacy and safety of aficamten in patients with very high left ventricular outflow tract gradients
- Beta-blocker use and new atrial fibrillation in post-septal myectomy patients
Additionally, at the Heart Failure Society of America (HFSA) Annual Scientific Meeting on September 30, 2024, a Late Breaking Clinical Trial presentation will discuss the global clinical impact of aficamten in obstructive hypertrophic cardiomyopathy, based on results from the SEQUOIA-HCM trial. These presentations highlight Cytokinetics' ongoing research in cardiac treatments, particularly focusing on aficamten's effects in hypertrophic cardiomyopathy patients.
Cytokinetics (Nasdaq: CYTK) announced positive results from the Phase 1 study of CK-4021586 (CK-586), a cardiac myosin inhibitor for potential treatment of heart failure with preserved ejection fraction (HFpEF). The study met its primary and secondary objectives, demonstrating safety, tolerability, and favorable pharmacokinetics of CK-586. Key findings include:
- No serious adverse events observed
- Half-life of 14-17 hours
- Dose-linearity without change in half-life
- Predictable PK/PD relationship
- Mean decrease in LVEF <5% at highest dose
These results support advancement to a Phase 2 clinical trial in HFpEF patients, expected to begin in Q4 2024.
Cytokinetics (Nasdaq: CYTK) has announced two presentations at the 2024 American College of Clinical Pharmacology (ACCP) Annual Meeting in Bethesda, MD, scheduled from September 8-10, 2024. The first presentation, titled 'A First-in-Human, Single & Multiple Ascending Dose Study of CK-4021586, A Novel Cardiac Myosin Inhibitor', will be presented by Justin Lutz, Senior Director of Clinical Pharmacology. The second presentation, 'Clinical Evaluation of the Effect of Aficamten on QT/QTc Interval in Healthy Participants', will be delivered by Polina German, Executive Director of Clinical Pharmacology. Both presentations are scheduled for September 8, 2024, during the Opening Reception, Exhibits & Poster Session 1, from 5:00-7:00 PM ET in the Grand Ballroom E-H.
Cytokinetics (Nasdaq: CYTK) announced inducement grants to new employees on August 30, 2024. The grants include:
1. For Brett Pletcher, Executive VP and Chief Legal Officer:
- 51,039 stock options
- 33,140 restricted stock units (RSUs)
- 14,603 performance stock units (PSUs)
2. For 18 additional employees:
- 59,429 stock options
- 38,586 RSUs
The stock options have an exercise price of $57.08 per share. RSUs vest over 3 years, while stock options vest over 4 years. PSUs are subject to performance goals. These grants were made as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).