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 (CYTK) has announced inducement grants to 9 new employees who joined in December 2024. The grants include:
- 52,188 stock options at $47.04 per share (closing price on Dec 31, 2024), vesting over 4 years with 1/4th after first year and 1/48th monthly thereafter
- 33,885 restricted stock units (RSUs) vesting over 3 years (40% after year 1, 40% after year 2, 20% after year 3)
- 3,189 performance stock units (PSUs) tied to two performance goals, with 50% of earned shares vesting upon goal certification and 50% one year later
All grants were made under Nasdaq Listing Rule 5635(c)(4) as material inducements to employment, subject to continued service requirements.
Cytokinetics (CYTK) announced that the European Medicines Agency (EMA) has validated their Marketing Authorization Application (MAA) for aficamten, a cardiac myosin inhibitor designed to treat obstructive hypertrophic cardiomyopathy (HCM). The application will be reviewed by the Committee for Medicinal Products for Human Use (CHMP).
The MAA is supported by results from the SEQUOIA-HCM Phase 3 clinical trial, published in the New England Journal of Medicine. This follows the FDA's acceptance of aficamten's New Drug Application (NDA) in the US, which has a PDUFA target action date of September 26, 2025. The drug is also under regulatory review in China.
Cytokinetics (CYTK) has granted equity-based compensation to 7 new employees who joined in November 2024. The package includes 34,515 stock options at an exercise price of $51.86 per share and 22,410 restricted stock units (RSUs).
The RSUs will vest over 3 years: 40% after year one, 40% after year two, and 20% after year three. The stock options will vest over 4 years: 25% after the first year, with the remaining vesting monthly over 36 months. The options have a 10-year term. These grants were made as employment inducements under Nasdaq Rule 5635(c)(4).
Cytokinetics (CYTK) announced the start of COMET-HF, a confirmatory Phase 3 clinical trial evaluating omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. The trial, conducted with Duke Clinical Research Institute, will enroll approximately 1,800 patients randomized 1:1 to receive omecamtiv mecarbil or placebo. The primary endpoint is time to first event in a composite of cardiovascular death, first heart failure event, LVAD implantation, cardiac transplantation, or stroke. Eligible patients must have ejection fraction <30%, NT-proBNP ≥1,000 pg/mL, and a heart failure event within six months. The study includes a two-week run-in period and two-week washout period before randomization.
Cytokinetics (CYTK) has announced its participation in two major investor conferences this December. The company will join the 7th Annual Evercore ISI HealthconX Conference for a fireside chat on December 3, 2024, at 9:35 AM ET in Coral Gables, FL. Additionally, they will participate in the 36th Annual Piper Sandler Healthcare Conference on December 4, 2024, at 8:00 AM ET in New York.
Both fireside chats will be accessible via live webcast through Cytokinetics' website's Investors & Media section, with recordings available for 90 days after the events.
Cytokinetics (CYTK) announced FDA acceptance of its New Drug Application (NDA) for aficamten, a cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (HCM). The FDA set a PDUFA target date of September 26, 2025, with standard review and no planned advisory committee meeting.
The NDA is supported by SEQUOIA-HCM Phase 3 trial results, which showed significant improvement in exercise capacity with aficamten versus placebo. The drug demonstrated positive impacts on exercise capacity, clinical outcomes, and cardiac biomarkers, with statistically significant improvements in all 10 prespecified secondary endpoints. Treatment-emergent serious adverse events were lower in the aficamten group (5.6%) compared to placebo (9.3%).
Cytokinetics (CYTK) and Bayer have established an exclusive licensing agreement for aficamten in Japan, focusing on treating hypertrophic cardiomyopathy (HCM). The deal includes an upfront payment of €50 million to Cytokinetics, with potential additional earnings of €90 million in milestones through commercial launch (including €20 million near-term) and up to €490 million in commercial milestone payments. The collaboration involves tiered royalties on Japanese sales and joint development plans, with Bayer conducting Phase 3 trials for obstructive HCM in Japan while Cytokinetics expands its ACACIA-HCM and CEDAR-HCM trials into the region.
Cytokinetics (CYTK) presented new post-hoc analyses of GALACTIC-HF, their Phase 3 trial of omecamtiv mecarbil for heart failure, at AHA Scientific Sessions 2024. The analyses showed that the drug reduced risk of adverse cardiac outcomes in severe heart failure patients regardless of age. Among 8,232 patients studied over 21.8 months, the treatment demonstrated significant risk reductions in both age groups (<65 and ≥65 years). The drug also showed potential benefits in reducing ventricular arrhythmias (VA) risk in patients with severely reduced left ventricular ejection fraction, while maintaining a favorable safety profile.
Cytokinetics presented new data for aficamten in hypertrophic cardiomyopathy (HCM) at the American Heart Association Scientific Sessions 2024. Analysis from SEQUOIA-HCM showed aficamten improved post-exercise oxygen uptake recovery and quality of life measures. FOREST-HCM data revealed that after 12 weeks of treatment, only 3% of previously eligible patients remained candidates for septal reduction therapy, down from 35%. Real-world cost analysis of 5,129 HCM patients showed significant cost variations: male patients had higher overall costs ($71,581 vs $63,710 for females), younger patients (18-39) faced higher costs across most categories, and notable cost differences were observed across racial/ethnic groups.
Cytokinetics (CYTK) has announced its participation in the 2024 Jefferies London Healthcare Conference. The company will engage in a fireside chat scheduled for Tuesday, November 19, 2024, at 4:00 PM GMT at The Waldorf Hilton Hotel in London.
A live webcast of the discussion will be accessible through the Investors & Media section of Cytokinetics' website. The replay will remain available on the company's website for 90 days after the event concludes.
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