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SOUTH SAN FRANCISCO, Calif., Oct. 21, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is scheduled to report third quarter results on November 4, 2026 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss financial results and provide business updates.

The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com or directly at the following link: Cytokinetics Q3 2026 Earnings Conference Call. An archived replay of the webcast will be available via Cytokinetics’ website for six months.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union, United Kingdom and Canada for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Disclaimer

Omecamtiv mecarbil and ulacamten are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). 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. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union, the United Kingdom and Canada.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

Key Takeaways Cytokinetics' Myqorzo surpassed 700 U.S. prescribers, with over 40% new-to-brand prescription share by Q2.Myqorzo launched in Germany, gained U.K. authorization and could enter additional markets through early 2027.Cytokinetics plans an nHCM filing in Q4 2026, while the FDA set a Nov. 14 action date for its oHCM sNDA.
Cytokinetics, Incorporated (CYTK - Free Report) is making encouraging commercial progress with its lead drug, Myqorzo (aficamten), following its December 2025 approval for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Adoption continued to expand, supported by growing physician awareness, prescribing activity, patient demand and market access.

More than 700 unique U.S. healthcare providers prescribed Myqorzo as of June 30. More than 80% of dispensed prescriptions were paid, while management’s internal analysis indicated that the drug exited the second quarter with more than 40% new-to-brand prescription share in the cardiac myosin inhibitor category.

Cytokinetics expanded Myqorzo’s international commercial reach with its June launch in Germany, marking the drug’s entry into its first European market. Myqorzo also received marketing authorization in the United Kingdom, where NICE recommended it for use in England and Wales. The company expects to launch the drug in additional markets later this year or in the first half of 2027.

Clinical developments could further strengthen Myqorzo’s growth prospects. Additional results from the phase III ACACIA-HCM study demonstrated improvements in cardiac structure and diastolic function in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The study had previously met both primary endpoints, showing statistically significant improvements in KCCQ Clinical Summary Score and maximal exercise performance (pVO2) versus placebo.

These findings suggest that aficamten’s potential benefits in nHCM may extend beyond improvements in symptoms and exercise capacity. With no approved therapies currently available for this indication, Cytokinetics plans to submit a supplemental new drug application (sNDA) in the fourth quarter of 2026. The approval could expand Myqorzo’s addressable market.

Separately, the FDA accepted the company’s sNDA based on the phase III MAPLE-HCM study, which evaluated aficamten as monotherapy against metoprolol in patients with oHCM. The FDA assigned a target action date of Nov. 14, 2026.

Continued commercial adoption, potential expansion into nHCM and launches in additional markets could support further Myqorzo sales growth and broaden its market opportunity.

Competition for CYTK’s MyqorzoMyqorzo operates within an evolving treatment landscape for oHCM. Its primary branded competitor is Camzyos, a cardiac myosin inhibitor marketed by Bristol Myers Squibb (BMY - Free Report) . In addition to this direct competition, Myqorzo faces established generic therapies, namely beta blockers and calcium channel blockers, which continue to serve as the first-line standard of care.

BMY obtained FDA approval for Camzyos in 2022 for the treatment of adults with symptomatic New York Heart Association class II-III obstructive HCM to improve functional capacity and symptoms.

The drug continues to gain traction in its target market, supported by growing demand and broader adoption among eligible patients, potentially boosting BMY’s top line.

The FDA recently approved the drug for treating symptomatic oHCM to improve functional capacity and symptoms in adults and pediatric patients weighing 30 kg (66 lbs) or more.

A potential competitor for Cytokinetics is Edgewise Therapeutics, Inc. (EWTX - Free Report) , which is advancing a cardiovascular pipeline targeting HCM, heart failure, and other cardiovascular and cardiometabolic conditions.

EWTX’s lead candidate, EDG-7500, is a novel, oral, selective cardiac sarcomere modulator currently being studied in a multipart phase II study in patients with oHCM and nHCM, with a phase III program targeted to be launched in the fourth quarter of 2026.

The company’s pipeline also includes EDG-15400 for heart failure. It recently announced the dosing of the first patient in EQUINOX-HFpEF, a phase II study evaluating EDG-15400 in adults with symptomatic heart failure with preserved ejection fraction who have a left ventricular ejection fraction of at least 50%.

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Maze Therapeutics (NASDAQ:MAZE – Get Free Report) and Cytokinetics (NASDAQ:CYTK – Get Free Report) are both healthcare companies, but which is the superior stock? We will contrast the two businesses based on the strength of their risk, institutional ownership, dividends, profitability, analyst recommendations, earnings and valuation.

Analyst Recommendations This is a breakdown of current ratings for Maze Therapeutics and Cytokinetics, as provided by MarketBeat.

Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Maze Therapeutics 1 0 9 3 3.08 Cytokinetics 1 1 18 0 2.85 Maze Therapeutics presently has a consensus target price of $63.40, indicating a potential upside of 128.88%. Cytokinetics has a consensus target price of $106.06, indicating a potential upside of 68.91%. Given Maze Therapeutics’ stronger consensus rating and higher possible upside, equities research analysts plainly believe Maze Therapeutics is more favorable than Cytokinetics.

Profitability This table compares Maze Therapeutics and Cytokinetics’ net margins, return on equity and return on assets. Net Margins Return on Equity Return on Assets Maze Therapeutics N/A -34.94% -30.18% Cytokinetics -1,321.12% N/A -51.01% Risk and Volatility Maze Therapeutics has a beta of 2.16, indicating that its share price is 116% more volatile than the S&P 500. Comparatively, Cytokinetics has a beta of 0.41, indicating that its share price is 59% less volatile than the S&P 500.

Valuation & Earnings This table compares Maze Therapeutics and Cytokinetics”s revenue, earnings per share (EPS) and valuation.

Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Maze Therapeutics $167.50 million 9.19 -$131.12 million ($2.52) -10.99 Cytokinetics $88.04 million 88.74 -$784.96 million ($7.22) -8.70 Maze Therapeutics has higher revenue and earnings than Cytokinetics. Maze Therapeutics is trading at a lower price-to-earnings ratio than Cytokinetics, indicating that it is currently the more affordable of the two stocks.

Summary Maze Therapeutics beats Cytokinetics on 9 of the 13 factors compared between the two stocks.

(Get Free Report)

We are a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. We are advancing a pipeline using our Compass platform, which allows us to identify and characterize genetic variants in disease and then link those variants to the biological pathways that drive disease in specific patient groups through a process we refer to as variant functionalization. Our Compass platform has been purpose-built to inform all phases of our drug discovery and development process through clinical trial design. We are currently advancing two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for chronic kidney disease, or CKD. Our goal is to bring novel precision medicines to patients to maximize our impact on human health. CKD is a serious, progressive condition that affects approximately 37 million patients in the United States, where it is expected to be the fifth most prevalent chronic disease by 2040. Current treatments for CKD consider patients as falling into clinical categories and focus on slowing the progression of disease, but do not target the underlying genetic drivers of disease. Our lead programs are designed to phenocopy, or mimic, the protective effects of certain genetic variants that are associated with reduced disease burden and improved kidney function in distinct groups of CKD patients. Our most advanced lead program, MZE829, is an oral, small molecule inhibitor of apolipoprotein L1, or APOL1, for the treatment of patients with APOL1 kidney disease, or AKD, which is estimated to affect over one million patients in the United States alone. Although the link between APOL1 variants and renal dysfunction has been known for over a decade, we have identified a new protective variant that underpins our therapeutic approach for MZE829 and may ultimately allow us to address a broader population of AKD than has previously been possible in the clinical setting. In October 2024, we reported results for our Phase 1 clinical trial of MZE829, in which we enrolled 111 healthy patients who received either single or multiple ascending doses of 20 mg to 480 mg of MZE829 administered daily. Treatment was well tolerated with no severe adverse events or serious adverse events reported in patients treated with single doses up to 480 mg and multiple doses of up to 350 mg daily for seven days. Dose-proportional pharmacokinetics, or PK, was observed with low variability (10-40%) across doses. We initiated a Phase 2 trial of MZE829 in November 2024 and expect to dose our first patient in the first quarter of 2025 and to report proof of concept data in the first quarter of 2026. Our second lead program, MZE782, is an oral, small molecule inhibitor of the solute transporter SLC6A19, a novel CKD target, with the potential to address approximately five million of the CKD patients in the United States with inadequate responses to currently available CKD therapies. Beyond its use as a potential standalone therapy, MZE782 may also provide a significant benefit to patients in combination with standard of care, including as a complementary treatment to current approved regimens or as an alternative option for those patients who do not adequately respond to today’s standard of care. We initiated a Phase 1 trial of MZE782 in September 2024 and expect to report initial data from this trial in the second half of 2025. In addition to CKD, we believe MZE782 may provide benefit to patients suffering from the genetically defined metabolic disease, phenylketonuria, or PKU. Following our ongoing Phase 1 trial of MZE782, we plan to conduct a parallel Phase 2 clinical trial to explore MZE782 as a potential treatment of PKU. Our Compass platform supports end-to-end variant identification and functionalization capabilities as well as advanced research tools and methodologies for drug development. We believe the process of variant functionalization, or understanding how genetic variants function to affect the course of disease, is a foundational aspect of precision medicine and one of the core capabilities that sets us apart from others in the field. We were incorporated under the laws of the State of Delaware on August 29, 2017, originally under the name Genetic Modifiers NewCo, Inc. We changed our name on July 5, 2018 to Modulus Therapeutics, Inc. and on September 25, 2018, to Maze Therapeutics, Inc. Our principal executive offices are located at 171 Oyster Point Blvd., Suite 300, South San Francisco, California.

About Cytokinetics (Get Free Report)

Cytokinetics, Incorporated, a late-stage biopharmaceutical company, focuses on discovering, developing, and commercializing muscle activators and inhibitors as potential treatments for debilitating diseases. The company develops small molecule drug candidates primarily engineered to impact muscle function and contractility. Its drug candidates include omecamtiv mecarbil, a novel cardiac myosin activator that is in Phase III clinical trial in patients with heart failure. The company also develops CK-136, a novel cardiac troponin activator that is in Phase I clinical trial; CK-586, a small molecule cardiac myosin inhibitor, that is in Phase I clinical trial; and aficamten, a novel cardiac myosin inhibitor, which is in Phase III clinical trial for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy. Cytokinetics, Incorporated has a strategic alliance with Ji Xing Pharmaceuticals Limited. The company was incorporated in 1997 and is headquartered in South San Francisco, California.

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Cytokinetics (NASDAQ:CYTK – Get Free Report) and Zai Lab (NASDAQ:ZLAB – Get Free Report) are both mid-cap healthcare companies, but which is the better investment? We will contrast the two businesses based on the strength of their profitability, valuation, dividends, institutional ownership, risk, earnings and analyst recommendations.

Risk & Volatility Cytokinetics has a beta of 0.41, meaning that its stock price is 59% less volatile than the S&P 500. Comparatively, Zai Lab has a beta of 0.73, meaning that its stock price is 27% less volatile than the S&P 500.

Insider and Institutional Ownership 41.6% of Zai Lab shares are owned by institutional investors. 2.6% of Cytokinetics shares are owned by insiders. Comparatively, 4.9% of Zai Lab shares are owned by insiders. Strong institutional ownership is an indication that hedge funds, endowments and large money managers believe a company is poised for long-term growth.

Valuation and Earnings This table compares Cytokinetics and Zai Lab”s gross revenue, earnings per share (EPS) and valuation. Gross Revenue Price/Sales Ratio Net Income Earnings Per Share Price/Earnings Ratio Cytokinetics $88.04 million 86.38 -$784.96 million ($7.22) -8.47 Zai Lab $460.16 million 6.26 -$175.54 million ($1.71) -14.80 Zai Lab has higher revenue and earnings than Cytokinetics. Zai Lab is trading at a lower price-to-earnings ratio than Cytokinetics, indicating that it is currently the more affordable of the two stocks.

Profitability This table compares Cytokinetics and Zai Lab’s net margins, return on equity and return on assets.

Net Margins Return on Equity Return on Assets Cytokinetics -1,321.12% N/A -51.01% Zai Lab -41.86% -27.43% -16.72% Analyst Recommendations This is a summary of current ratings for Cytokinetics and Zai Lab, as reported by MarketBeat.com.

Sell Ratings Hold Ratings Buy Ratings Strong Buy Ratings Rating Score Cytokinetics 1 1 18 0 2.85 Zai Lab 1 1 4 1 2.71 Cytokinetics presently has a consensus target price of $106.00, indicating a potential upside of 73.43%. Zai Lab has a consensus target price of $37.25, indicating a potential upside of 47.18%. Given Cytokinetics’ stronger consensus rating and higher possible upside, equities analysts plainly believe Cytokinetics is more favorable than Zai Lab.

Summary Zai Lab beats Cytokinetics on 9 of the 15 factors compared between the two stocks.

About Cytokinetics (Get Free Report)

Cytokinetics, Incorporated, a late-stage biopharmaceutical company, focuses on discovering, developing, and commercializing muscle activators and inhibitors as potential treatments for debilitating diseases. The company develops small molecule drug candidates primarily engineered to impact muscle function and contractility. Its drug candidates include omecamtiv mecarbil, a novel cardiac myosin activator that is in Phase III clinical trial in patients with heart failure. The company also develops CK-136, a novel cardiac troponin activator that is in Phase I clinical trial; CK-586, a small molecule cardiac myosin inhibitor, that is in Phase I clinical trial; and aficamten, a novel cardiac myosin inhibitor, which is in Phase III clinical trial for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy. Cytokinetics, Incorporated has a strategic alliance with Ji Xing Pharmaceuticals Limited. The company was incorporated in 1997 and is headquartered in South San Francisco, California.

About Zai Lab (Get Free Report)

Zai Lab Limited develops and commercializes therapies to treat oncology, autoimmune disorders, infectious diseases, and neuroscience. Its commercial products include Zejula, an orally administered poly polymerase 1/2 inhibitor; Optune, a cancer therapy that uses electric fields tuned to specific frequencies to kill tumor cells; NUZYRA for acute bacterial skin and skin structure infections, and community acquired bacterial pneumonia; Qinlock to treat gastrointestinal stromal tumors, and VYVGART, a human IgG1 antibody fragment for myesthenia gravis. The company also develops Tumor Treating Fields, a portable device for delivery of electric fields; Repotrectinib, a tyrosine kinase inhibitor (TKI) to target ROS1 and TRK A/B/C in TKI-naïve- or -pretreated cancer patients; Tisotumab vedotin, an antibody drug conjugate; Adagrasib for treating KRAS-G12C-mutated NSCLC, colorectal cancer, and pancreatic cancer; and Bemarituzumab to treat gastric and gastroesophageal junction cancer patients. In addition, it develops Sulbactam/durlobactam, a combination of a beta-lactam antibiotic and a beta-lactamase inhibitor for the treatment of serious infections caused by Acinetobacter; KarXT for the treatment of psychiatric and neurological conditions. It has license and collaboration agreement with Tesaro, Inc. to develop, manufacture, and commercialize niraparib; NovoCure to develop and commercialize Tumor Treating Fields; Deciphera to develop and commercialize ripretinib; Paratek Bermuda Ltd. to develop, manufacture, and commercialize omadacycline; argenx, to develop and commercialize efgartigimod; BMS to develop and commercialize tisotumab vedotin and repotrectinib; Mirati to research, develop, manufacture, and commercialize adagrasib; Amgen to develop and commercialize bemarituzumab; and Innoviva to develop and commercialize Sulbactam-Durlobactam; Karuna to develop and commercialize KarXT. The company was incorporated in 2013 and is headquartered in Shanghai, China.

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Multi-center Prospective Study to Track Real-World Safety, Clinical Effectiveness, and Healthcare Resource Impact of MYQORZO in Routine Clinical Practice

SOUTH SAN FRANCISCO, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the start of ASPEN-HCM (Aficamten Study of Patient Experience and Novel Outcomes in Symptomatic Obstructive HCM), a prospective, multicenter, observational real-world study evaluating MYQORZO® (aficamten) in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). MYQORZO is a once-daily, oral allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.

“We are pleased to announce the start of ASPEN-HCM, marking an important next step in our ongoing commitment to hypertrophic cardiomyopathy research,” said Sanatan Shreay, Ph.D., Cytokinetics’ Executive Director, Head of Health Economics and Outcomes Research. “The clinical trials we conducted of MYQORZO provided strong evidence supporting its approval. Now, this study will build on that foundation by generating valuable real-world insights that can help inform clinical decision-making and support clinicians in their everyday practices.”

Led by the University of California, San Francisco (UCSF), ASPEN-HCM will evaluate the safety and effectiveness of MYQORZO in routine clinical practice to generate prospective, real-world evidence on the clinical and economic impact of treatment.

“With our deep commitment to driving innovation in cardiology, this important study is designed to provide critical insights about the impact of the latest non-invasive treatment in HCM, the most common inherited heart disease,” said Theodore Abraham, M.D., co-director, UCSF HCM Center of Excellence.

ASPEN-HCM: Study Design

This prospective, multicenter, observational real-world study is designed to evaluate the clinical, economic, and patient impact of MYQORZO in adult patients with oHCM across 13 cardiology practices and HCM centers of excellence. Over an anticipated 12-to-36-month period, the study aims to enroll approximately 400 patients to characterize the real-world safety profile of MYQORZO.

The study will evaluate real-world safety and effectiveness outcomes, including reductions in left ventricular ejection fraction (LVEF), treatment discontinuations, changes in in left ventricular outflow tract gradient (LVOT–G), New York Heart Association (NYHA) classification, and patient-reported outcomes.

Secondary study objectives focus on analyzing healthcare resource utilization, conducting pre-and-post economic analyses on hospitalization and procedure rates, and tracking cardiac structural remodeling using parameters like left ventricular mass index and septal thickness.

Additionally, the study will investigate longitudinal treatment patterns, dose titration pathways, the prevalence and incidence of atrial fibrillation, potential predictors of treatment response, and the clinical impact of MYQORZO on avoiding or delaying invasive septal reduction therapy.

To learn more about ASPEN-HCM, visit www.clinicaltrials.gov.

The full U.S. Prescribing Information for MYQORZO includes a Boxed WARNING for the risk of heart failure. MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction. Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program. Please see additional Important Safety Information including Boxed WARNING below.

About MYQORZO® (aficamten)

MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union and United Kingdom for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.3

Aficamten is also under clinical investigation in CEDAR-HCM in a pediatric population with oHCM. Safety and efficacy of aficamten have not been established in a pediatric patient population. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study.

INDICATION

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILUREMYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction.

Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program.

CONTRAINDICATIONS

MYQORZO is contraindicated with concomitant use of rifampin.

WARNINGS AND PRECAUTIONS

Heart Failure

MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure.
Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure.

Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure.

Initiation of MYQORZO in patients with LVEF <55% is not recommended.

MYQORZO REMS Program

MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction.

Notable requirements of the MYQORZO REMS Program include:

Prescribers must be certified by enrolling in the MYQORZO REMS ProgramPatients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirementsPharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZOWholesalers and distributors must only distribute to certified pharmacies Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367.

Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness

MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (e.g., fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (e.g., rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly.

Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment.

ADVERSE REACTIONS

Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial.

INDICATIONS AND USAGE

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

Please see full Prescribing Information approved in the U.S., including Boxed WARNING.

Please see full Summary of Product Characteristics approved in the European Union.

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. HCM can be obstructive, when thickened muscle blocks blood flow, or non-obstructive, when blood flow is not blocked but heart function is still affected. In obstructive HCM, the thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller, stiffer and less able to relax and fill with blood. Ultimately, HCM limits the heart’s pumping function, leading to reduced exercise capacity and a variety of symptoms.

HCM is the most common monogenic inherited cardiovascular disorder, affecting approximately one out of 350 individuals worldwide.1

Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).2.

People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.3 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.4 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the approved in the U.S., China, European Union and United Kingdom for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). 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. Examples of such statements include, but are not limited to, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. 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 C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union and the United Kingdom.

References

Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4;27:200485. doi:10.1016/j.ijcrp.2025.200485.Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552.Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260.Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic. Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

Cytokinetics, Incorporated (NASDAQ:CYTK – Get Free Report) EVP Fady Malik sold 3,500 shares of the firm’s stock in a transaction on Tuesday, September 22nd. The shares were sold at an average price of $68.29, for a total value of $239,015.00. Following the transaction, the executive vice president directly owned 153,902 shares in the company, valued at $10,509,967.58. This trade represents a 2.22% decrease in their ownership of the stock. The sale was disclosed in a document filed with the SEC, which is available at this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.

Fady Ibraham Malik also recently made the following trade(s):

On Tuesday, September 8th, Fady Malik sold 3,500 shares of Cytokinetics stock. The stock was sold at an average price of $75.46, for a total transaction of $264,110.00. On Tuesday, August 18th, Fady Malik sold 3,500 shares of Cytokinetics stock. The shares were sold at an average price of $75.82, for a total transaction of $265,370.00. On Tuesday, July 21st, Fady Malik sold 3,500 shares of Cytokinetics stock. The shares were sold at an average price of $80.59, for a total transaction of $282,065.00. On Tuesday, July 7th, Fady Malik sold 3,500 shares of Cytokinetics stock. The stock was sold at an average price of $86.62, for a total transaction of $303,170.00. Cytokinetics Trading Up 0.0% Shares of NASDAQ:CYTK opened at $67.59 on Wednesday. The company has a 50 day moving average of $75.93 and a 200-day moving average of $73.04. The firm has a market cap of $8.41 billion, a P/E ratio of -9.36 and a beta of 0.36. Cytokinetics, Incorporated has a twelve month low of $47.22 and a twelve month high of $88.31.

Cytokinetics (NASDAQ:CYTK – Get Free Report) last announced its earnings results on Thursday, August 6th. The biopharmaceutical company reported ($1.50) EPS for the quarter, topping the consensus estimate of ($1.63) by $0.13. The firm had revenue of $28.62 million for the quarter, compared to the consensus estimate of $17.59 million. Cytokinetics’s revenue for the quarter was down 57.1% on a year-over-year basis. During the same period in the previous year, the firm earned ($1.12) EPS. Equities research analysts forecast that Cytokinetics, Incorporated will post -5.98 EPS for the current year. Analyst Ratings Changes CYTK has been the subject of several research reports. Barclays raised their target price on Cytokinetics from $95.00 to $110.00 and gave the company an “overweight” rating in a research note on Thursday, August 13th. Cantor Fitzgerald reissued an “overweight” rating on shares of Cytokinetics in a report on Friday, September 11th. UBS Group upgraded shares of Cytokinetics from a “neutral” rating to a “buy” rating and raised their price objective for the company from $69.00 to $115.00 in a research report on Monday, June 29th. Truist Financial lifted their price objective on shares of Cytokinetics from $106.00 to $112.00 and gave the stock a “buy” rating in a research note on Monday, August 10th. Finally, Wall Street Zen downgraded shares of Cytokinetics from a “hold” rating to a “sell” rating in a report on Saturday, August 29th. Eighteen analysts have rated the stock with a Buy rating, one has given a Hold rating and one has issued a Sell rating to the company’s stock. According to data from MarketBeat.com, the stock currently has a consensus rating of “Moderate Buy” and a consensus target price of $103.37.

Check Out Our Latest Stock Report on Cytokinetics

Hedge Funds Weigh In On Cytokinetics Institutional investors have recently bought and sold shares of the stock. Handelsbanken Fonder AB grew its stake in Cytokinetics by 63.8% during the 2nd quarter. Handelsbanken Fonder AB now owns 405,000 shares of the biopharmaceutical company’s stock valued at $34,502,000 after acquiring an additional 157,700 shares in the last quarter. Royce & Associates LP increased its holdings in shares of Cytokinetics by 44.3% in the 4th quarter. Royce & Associates LP now owns 144,426 shares of the biopharmaceutical company’s stock valued at $9,177,000 after purchasing an additional 44,343 shares during the period. Norges Bank purchased a new stake in shares of Cytokinetics in the fourth quarter worth approximately $51,281,000. Siren L.L.C. acquired a new stake in shares of Cytokinetics during the first quarter worth approximately $40,466,000. Finally, Eventide Asset Management LLC boosted its holdings in shares of Cytokinetics by 181.9% during the fourth quarter. Eventide Asset Management LLC now owns 479,611 shares of the biopharmaceutical company’s stock worth $30,473,000 after purchasing an additional 309,503 shares during the period.

About Cytokinetics (Get Free Report)

Cytokinetics, Incorporated is a biopharmaceutical company focused on discovering and developing medicines that target the biology of muscle function. The company applies expertise in muscle physiology and contractility to develop potential treatments for cardiovascular and neuromuscular diseases.

Its leading programs include aficamten, an investigational cardiac myosin inhibitor being developed for conditions involving abnormal heart-muscle contraction, including hypertrophic cardiomyopathy.

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Cytokinetics, Incorporated (NASDAQ:CYTK – Get Free Report) CEO Robert Blum sold 97,926 shares of Cytokinetics stock in a transaction that occurred on Tuesday, September 15th. The shares were sold at an average price of $69.33, for a total value of $6,789,209.58. Following the transaction, the chief executive officer owned 385,320 shares of the company’s stock, valued at approximately $26,714,235.60. This represents a 20.26% decrease in their ownership of the stock. The sale was disclosed in a filing with the SEC, which is available through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.

Cytokinetics Trading Up 0.1% Cytokinetics stock opened at $69.39 on Thursday. The firm has a market cap of $8.63 billion, a PE ratio of -9.61 and a beta of 0.36. The stock’s 50 day simple moving average is $77.15 and its two-hundred day simple moving average is $72.85. Cytokinetics, Incorporated has a 12 month low of $47.22 and a 12 month high of $88.31.

Cytokinetics (NASDAQ:CYTK – Get Free Report) last posted its earnings results on Thursday, August 6th. The biopharmaceutical company reported ($1.50) earnings per share (EPS) for the quarter, beating the consensus estimate of ($1.63) by $0.13. The firm had revenue of $28.62 million during the quarter, compared to analyst estimates of $17.59 million. The business’s revenue for the quarter was down 57.1% on a year-over-year basis. During the same quarter in the prior year, the firm earned ($1.12) earnings per share. On average, equities research analysts forecast that Cytokinetics, Incorporated will post -5.98 EPS for the current year.

Analysts Set New Price Targets Several equities research analysts have recently issued reports on CYTK shares. Needham & Company LLC increased their target price on shares of Cytokinetics from $102.00 to $112.00 and gave the stock a “buy” rating in a research note on Friday, August 7th. Barclays lifted their price target on Cytokinetics from $95.00 to $110.00 and gave the company an “overweight” rating in a research note on Thursday, August 13th. HC Wainwright reiterated a “buy” rating and set a $140.00 price target on shares of Cytokinetics in a research report on Monday, August 31st. Royal Bank Of Canada dropped their price objective on Cytokinetics from $117.00 to $112.00 and set an “outperform” rating on the stock in a report on Friday, August 7th. Finally, JPMorgan Chase & Co. boosted their price objective on Cytokinetics from $97.00 to $103.00 and gave the company an “overweight” rating in a research report on Thursday, August 13th. Eighteen equities research analysts have rated the stock with a Buy rating, one has assigned a Hold rating and one has given a Sell rating to the stock. Based on data from MarketBeat.com, the stock currently has an average rating of “Moderate Buy” and a consensus target price of $103.37. Read Our Latest Research Report on CYTK

Institutional Inflows and Outflows Several institutional investors have recently modified their holdings of the stock. Geode Capital Management LLC grew its holdings in shares of Cytokinetics by 0.5% in the fourth quarter. Geode Capital Management LLC now owns 3,056,017 shares of the biopharmaceutical company’s stock valued at $194,214,000 after purchasing an additional 15,815 shares during the period. Principal Financial Group Inc. grew its stake in shares of Cytokinetics by 11.9% in the 1st quarter. Principal Financial Group Inc. now owns 1,093,485 shares of the biopharmaceutical company’s stock valued at $72,072,000 after buying an additional 116,593 shares during the period. Frazier Life Sciences Management L.P. increased its holdings in shares of Cytokinetics by 5.0% during the 4th quarter. Frazier Life Sciences Management L.P. now owns 934,642 shares of the biopharmaceutical company’s stock worth $59,387,000 after buying an additional 44,197 shares during the last quarter. Fisher Asset Management LLC increased its holdings in shares of Cytokinetics by 8.0% during the 4th quarter. Fisher Asset Management LLC now owns 822,885 shares of the biopharmaceutical company’s stock worth $52,286,000 after buying an additional 61,298 shares during the last quarter. Finally, Norges Bank purchased a new stake in shares of Cytokinetics during the 4th quarter valued at approximately $51,281,000.

Cytokinetics Company Profile (Get Free Report)

Cytokinetics, Incorporated is a biopharmaceutical company focused on discovering and developing medicines that target the biology of muscle function. The company applies expertise in muscle physiology and contractility to develop potential treatments for cardiovascular and neuromuscular diseases.

Its leading programs include aficamten, an investigational cardiac myosin inhibitor being developed for conditions involving abnormal heart-muscle contraction, including hypertrophic cardiomyopathy.

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Cytokinetics, Incorporated (CYTK) Morgan Stanley 24th Annual Global Healthcare Conference September 14, 2026 7:45 AM EDT

Company Participants

Robert I. Blum - CEO, President & Director
Andrew Callos - Executive VP & Chief Commercial Officer
Fady Malik - Executive Vice President of Research & Development
Sung Lee - EVP & CFO

Conference Call Participants

Maxwell Skor - Morgan Stanley, Research Division

Presentation

Maxwell Skor
Morgan Stanley, Research Division

Great. Thank you, everyone, for joining. I'm Max Skor, biotech analyst with Morgan Stanley.

And before we get started, for important disclosures, please see the Morgan Stanley Research Disclosures website at www.morganstanley.com/researchdisclosures.

And I'm very happy to welcome the Cytokinetics team: Robert Blum, CEO; Sung Lee, CFO; Andrew Callos, Chief Commercial Officer; Fady Malik, Research & Development.

Welcome, team. Thank you very much for joining us today.

Robert I. Blum
CEO, President & Director

Thank you.

Maxwell Skor
Morgan Stanley, Research Division

And maybe just to start off, so Robert, we're in the early stages of the MYQORZO launch. Could you just walk us through key learnings at this point and what we should really focus on going forward into year-end?

Robert I. Blum
CEO, President & Director

So MYQORZO, aficamten, was engineered with certain properties in mind and was developed very much to elaborate on those properties. And I think those are playing well to what we hope ultimately proves competitive advantage in the marketplace: ease of use, flexibility, convenience. These are things that we think matter, especially for a second to entry in a category of cardiovascular medicine.

And I do believe that, as we have projected, we're on track for some pretty ambitious goals. Goals like preferential share of new scripts by the end of the year; goals like parity market access. That's all translating into very solid launch velocity and momentum. Andrew can elaborate. But we reported

Cytokinetics, Incorporated (CYTK) Citigroup's Biopharma Back to School Summit 2026 September 9, 2026 3:00 PM EDT

Company Participants

Robert I. Blum - CEO, President & Director
Daniel Jacoby - Vice President of Clinical Research
Tricia Ottaviani - SVP of U.S. and Global Marketing & Operations
Sung Lee

Conference Call Participants

Eric Joseph - Citigroup Inc., Research Division

Presentation

Eric Joseph
Citigroup Inc., Research Division

Welcome again to Citi's Back to School Biopharma Conference. I'm Eric Joseph, senior biotech analyst with Citi. And our session this afternoon is with Cytokinetics, and I'm delighted to be joined by Robert Blum and several members of the Cytokinetics team. Thank you all for joining us today. Rob, maybe, Robert, just before hopping into Q&A, I can have you start out with some high-level remarks, and then we'll go from there.

Robert I. Blum
CEO, President & Director

So thank you, and thanks for inviting us to participate in this Back to School Event. It's our first opportunity to interact with investors in person after returning from Munich, where data from ACACIA-HCM were presented to a very, very large congress hall very, very well attended and positive reception on the part of cardiologists there attending that conference in Munich.

And those results from ACACIA, we believe, provide a very important milestone and catalyst for what could be additional value creation that may come our way as that could be data incorporated into a submission for FDA and other regulatory authorities review and potential approval and ultimately enable MYQORZO to be the first cardiac myosin inhibitor approved across the full spectrum of HCM patients.

Why does that matter? Because we're already demonstrating with our commercial launch of MYQORZO in oHCM that it is rapidly ascending and where we've pointed to by the end of the year, we expect to see

SOUTH SAN FRANCISCO, Calif., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that members of the Company management team will participate in the following investor conferences in September:

Citi 2026 BioPharma Back to School Conference: Fireside chat on Wednesday, September 9, 2026 at 3:00 PM Eastern Time in New York, NY.Cantor Global Healthcare Conference 2026: Fireside chat on Thursday, September 10, 2026 at 11:30 AM Eastern Time in New York, NY.Morgan Stanley 24th Annual Global Healthcare Conference: Fireside chat on Monday, September 14, 2026 at 7:45 AM Eastern Time in New York, NY.Bernstein 3rd Annual Healthcare Forum: Fireside chat on Wednesday, September 23, 2026 at 8:50 AM Eastern Time in New York, NY. Interested parties may access the live webcasts of the fireside chats by visiting the Investors & Media section of the Cytokinetics website at http://www.cytokinetics.com. The webcast replays will be archived on the Cytokinetics website for 90 days following the conclusion of the event.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the approved in the U.S., China, European Union and United Kingdom for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). 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. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics' business outlined in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union and the United Kingdom.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

ACACIA-HCM is the First Phase 3 Clinical Trial to Successfully Demonstrate Statistically Significant Improvements Across Both Patient-Reported and Physician-Assessed Endpoints in Non-Obstructive HCM

Supplemental New Drug Application to be Submitted to FDA in Fourth Quarter

Company to Host Investor Event and Webcast Today at 2:00 PM Central European Summer Time (8:00 AM Eastern Time)

SOUTH SAN FRANCISCO, Calif., Aug. 28, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the primary results from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) were presented in a Hot Line Session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, and simultaneously published in The New England Journal of Medicine.1

ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 compared to placebo in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance (pVO2). Results for the dual primary endpoint analysis consistently favored aficamten across prespecified subgroups studied.

Based on the positive results from ACACIA-HCM, Cytokinetics plans to submit a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for aficamten for the treatment of adult patients with symptomatic nHCM in the fourth quarter of 2026.

“ACACIA-HCM is the first-ever positive clinical trial in non-obstructive HCM,” said Stephen Heitner, M.D., Cytokinetics’ Chief Medical Officer. “As shown in presentation and publication, the results from ACACIA-HCM are both statistically robust, consistent across prespecified subgroups and other secondary endpoints, and clinically impactful for these patients with non-obstructive HCM. As such, these data may potentially translate into a new treatment option for patients with HCM with no available medical treatments that directly address their underlying disease. If approved, we look forward to seeing aficamten become the first cardiac myosin inhibitor to treat the full spectrum of symptomatic HCM.”

“We are grateful to the patient community and the clinical trial team who contributed to the successful completion of ACACIA-HCM, a fitting tribute to the patients and families who have struggled with this disease for many years and across generations. We are also pleased that most of the eligible patients from ACACIA-HCM are continuing treatment with aficamten in FOREST-HCM,” said Ahmad Masri, M.D., M.S., Director, Hypertrophic Cardiomyopathy Center and Cardiac Amyloidosis Program, Oregon Health & Science University and Principal Investigator of ACACIA-HCM. “We look forward to applying this study’s groundbreaking scientific knowledge into clinical practice upon potential approval, addressing this area of HCM where patients do not have adequate treatment options.”

ACACIA-HCM: Efficacy

The baseline characteristics of patients enrolled in ACACIA-HCM were well-matched between treatment groups and consistent with a symptomatic nHCM phenotype with substantial disease burden despite normal left ventricular ejection fraction (LVEF).

There were two pre-specified primary endpoints, KCCQ-CSS and pVO₂, evaluated in parallel. For each endpoint, a p-value of 0.025 or less was considered statistically significant. Compared to placebo, treatment with aficamten demonstrated statistically significant improvements in both dual primary endpoints at 36 weeks (Table 1).

Table 1: Dual Primary Endpoint Results

Primary
EndpointsChange from Baseline to Week 36
LSM [95% CI]Aficamten
vs Placebo
LSM (95% CI)P-value AficamtenPlacebo  KCCQ-CSS11.4 [9.6 – 13.2]8.4 [6.6 – 10.2]3.0 (0.5 - 5.5)0.021pVO2 (ml/kg/min)0.64 [0.32 – 0.95]-0.03 [-0.35 – 0.28]0.67 (0.22 - 1.1)0.003LSM = least square mean; CI = confidence interval
Improvements in KCCQ-CSS relative to placebo were noted beyond titration and throughout the treatment period in participants treated with aficamten, such that patients remaining on treatment at 72 weeks demonstrated a least square mean (LSM) change from baseline in KCCQ-CSS of 7.0 points. Of note, following a washout of aficamten for four weeks, the KCCQ-CSS declined from the end of treatment for participants on aficamten to match that in the placebo group (Figure 1).

Figure 1: Assessment of KCCQ-CSS

The figure is based on the observed data, except that the inset box of Week 36 LSM difference and p-value are from the primary analysis imputed data.

At Week 36, pVO2 increased for participants on aficamten while it remained unchanged for participants on placebo (Figure 2).

Figure 2: Assessment of pVO2

The treatment effect of aficamten on both dual primary endpoints was consistent across all prespecified subgroups, including baseline LVEF, atrial fibrillation status, genotype, age, sex, whether patients were receiving background beta-blocker therapy and whether patients had intracavitary obstruction at baseline (Figure 3).

Figure 3: Pre-Specified Subgroups for KCCQ-CSS and pVO2

Statistically significant improvements compared to placebo were observed in key ranked secondary endpoints, including New York Heart Association (NYHA) Functional Class, the composite z-score of two cardiopulmonary exercise testing (CPET) parameters (VE/VCO2 and pVO2), and NT-proBNP, a biomarker of cardiac wall stress. Statistical significance was not met on the endpoints of change from baseline in left atrial volume index or the time to first cardiovascular event for aficamten compared to placebo (Table 2).

Table 2: Secondary Endpoints

Secondary
EndpointsChange from Baseline to Week 36
LSM (95% CI)Aficamten vs
Placebo
Treatment
Difference
(95% CI)P-value AficamtenPlacebo  Improvement of ≥1 NYHA class at week 36 – n (%)108 (41.9)72 (27.8)14.1 (6.0 to 22.2)<0.001Change in composite z-score of two CPET parameters (pVO2 and VE/VCO2) at week 360.05 (-0.01 to 0.12)-0.09 (-0.14 to -0.05)0.14 (0.07 to 0.22)<0.001Proportional change in NT-proBNP level at week 36 – pg/ml0.43 (0.39 to 0.46)1.00 (0.93 to 1.08)0.43 (0.38 to 0.47)<0.001Change in left atrial volume index at week 36-0.17 (-1.12 to 0.79)1.13 (0.19 to 2.08)-1.30 (-2.64 to 0.04)
0.058Time to first cardiovascular event – weeks68.2 (66.2 to 70.2)68.8 (66.9 to 70.7)-0.6 (-3.3 to 2.2)
0.678Treatment difference is from statistical modeling
ACACIA-HCM: Safety

Aficamten was generally well-tolerated in the study. Non-fatal adverse events that led to early study drug discontinuation occurred in 18 (7.0%) and 5 (1.9%) patients on aficamten and placebo, respectively. Serious adverse events occurred in 52 (20.2%) patients on aficamten compared to 38 (14.7%) patients on placebo. In the time to the first cardiovascular event endpoint, an event (cardiovascular death, heart transplantation or left ventricular assist device, aborted sudden cardiac death, non-fatal stroke, heart failure hospitalization, or cardiac arrhythmia [atrial fibrillation or ventricular tachyarrhythmia] requiring treatment or hospitalization) occurred in 22 (8.5%) patients in the aficamten arm and 20 (7.7%) in the placebo arm.

LVEF <50% occurred in 27 (10.5%) patients taking aficamten and in two (0.8%) patients taking placebo. At baseline, patients who experienced LVEF <50% tended to have lower LVEF, lower exercise capacity, and a higher frequency of atrial fibrillation history. Of the 27 patients with LVEF <50% on aficamten, 21 completed treatment while receiving the same or lower doses.

As previously reported, two participants on aficamten experienced a serious adverse event of heart failure associated with LVEF <50%. Ten additional patients on aficamten had serious adverse events of heart failure not associated with LVEF <50%, compared to three patients on placebo. All heart failure events in patients treated with aficamten occurred during dose titration or prior to Week 12 and were generally responsive to a short course of diuretic therapy.

ACACIA-HCM: Global Efficacy Analysis

An additional analysis from ACACIA-HCM was also presented during the Hot Line presentation which evaluated the global efficacy of aficamten in patients with symptomatic nHCM. The analysis assessed clinical improvements across five key domains: exercise capacity, cardiac structure, cardiac biomarkers, diastolic function and symptom burden.

At 36 weeks, treatment with aficamten demonstrated statistically significant improvements across all five efficacy metrics compared to placebo (p<0.001), with 53% of patients on aficamten demonstrating a clinical response in three or more outcome measures compared to only 13% of patients on placebo. These results help place the primary results into clinical context and underscore the opportunity to impact several aspects of disease burden by addressing the underlying pathobiology in patients living with symptomatic nHCM. The results from this sub-analysis were also published in Circulation.2

Investor Webcast Information

Cytokinetics will host an in-person investor event in Munich, Germany on August 28, 2026, at 2:00 PM Central European Summer Time (8:00 AM Eastern Time). The event will also be simultaneously webcast live online. Interested parties must register to attend in-person or online at https://acacia-hcm-investor-event-esc-2026.open-exchange.net/welcome.

Registered attendees may access the webcast by visiting the Investor & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay will be archived on the Cytokinetics website for six months.

About ACACIA-HCM

ACACIA-HCM was a Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of aficamten compared to placebo in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The dual primary endpoint was the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score and change in maximal exercise performance (pVO2) from baseline to Week 36.

Secondary endpoints included the proportion of participants with ≥1 class improvement in NYHA functional class, and changes in the composite z-score of two cardiopulmonary exercise testing (CPET) parameters of sub-maximal exercise performance (VE/VCO2 and pVO2), NT-proBNP, and left atrial volume index (LAVI) from baseline to Week 36. After 36 weeks of treatment, participants continued treatment with aficamten or placebo for up to 72 weeks to evaluate additional secondary and exploration analyses including the time to first cardiovascular event. The trial (outside Japan) concluded when at least 200 patients completed 52 weeks of treatment.

ACACIA-HCM randomized and treated 517 participants (outside Japan) on a 1:1 basis with aficamten or placebo. Randomization was stratified by persistent atrial fibrillation and presence of intracavitary obstruction. At screening, participants enrolled in ACACIA-HCM were required to have resting left ventricular outflow tract gradient (LVOT-G) <30 mmHg and post-Valsalva LVOT-G <50 mmHg in addition to left ventricular ejection fraction (LVEF) ≥60%, respiratory exchange ratio (RER) ≥1.00 and pVO2 ≤90% predicted, NT-proBNP ≥300 pg/mL or ≥900 pg/mL if atrial fibrillation or atrial flutter were present at screening, NYHA functional class II or III and KCCQ Clinical Summary Score ≤85.

Each patient received up to four escalating doses of aficamten or placebo based on echocardiographic guidance. Participants who received aficamten began with 5 mg dosed once daily. At weeks 2, 4 and 6 participants received an echocardiogram to determine if they would be up-titrated to escalating doses of 10, 15 or 20 mg. Dose escalation occurred only if a participant had an LVEF ≥60%. Participants who did not meet escalation criteria continued the same dose or were down-titrated if their LVEF was <50%.

About MYQORZO® (aficamten)

MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union and United Kingdom for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.3

Aficamten is also under clinical investigation in CEDAR-HCM in a pediatric population with oHCM. Safety and efficacy of aficamten have not been established in a pediatric patient population. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study.

INDICATION

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction.

Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program.

CONTRAINDICATIONS

MYQORZO is contraindicated with concomitant use of rifampin.

WARNINGS AND PRECAUTIONS

Heart Failure

MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure.
Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure.

Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure.

Initiation of MYQORZO in patients with LVEF <55% is not recommended.

MYQORZO REMS Program

MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction.

Notable requirements of the MYQORZO REMS Program include:

Prescribers must be certified by enrolling in the MYQORZO REMS ProgramPatients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirementsPharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZOWholesalers and distributors must only distribute to certified pharmacies Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367.

Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness

MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (eg, fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (eg, rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly.

Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment.

ADVERSE REACTIONS

Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial.

INDICATIONS AND USAGE

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

Please see full Prescribing Information approved in the U.S., including Boxed WARNING.

Please see full Summary of Product Characteristics approved in the European Union.

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. HCM can be obstructive, when thickened muscle blocks blood flow, or non-obstructive, when blood flow is not blocked but heart function is still affected. In obstructive HCM, the thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller, stiffer and less able to relax and fill with blood. Ultimately, HCM limits the heart’s pumping function, leading to reduced exercise capacity and a variety of symptoms.

HCM is the most common monogenic inherited cardiovascular disorder, affecting approximately 1 out of 350 individuals worldwide.4

Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).5

People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.6 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.7 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the approved in the U.S., China, European Union and United Kingdom for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). 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. Examples of such statements include, but are not limited to, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. 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 C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union and the United Kingdom.

References

Masri A, et al. Aficamten for symptomatic nonobstructive hypertrophic cardiomyopathy. N Engl J Med. 2026Maron MS, et al. Global Efficacy of Aficamten in Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM. Circ. 2026Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424.Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4;27:200485. doi:10.1016/j.ijcrp.2025.200485.Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552.Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260.Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic.
Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

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Analysts Think There's Still Time to Get in on Edgewise, Up 332%Cytokinetics NASDAQ: CYTK presented primary results from its Phase III ACACIA-HCM trial evaluating aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy, or nHCM, reporting that the study met its dual primary endpoints for patient-reported health status and exercise capacity.

The results were presented at a cardiology congress in Munich and were accompanied by publications in the New England Journal of Medicine and Circulation, according to Fady Malik, Cytokinetics’ executive vice president of research and development. Malik said the company plans to submit a supplemental new drug application to the FDA for aficamten in nHCM later this year.

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Trial Results Want Diversified Upside in Biotechnology? Check out LABUACACIA-HCM enrolled 517 patients with symptomatic nHCM and randomized them equally to aficamten or placebo. Patients received aficamten doses ranging from 5 milligrams to 20 milligrams and were followed in a blinded manner for up to 72 weeks, including a four-week withdrawal period. The primary analysis was conducted at week 36.

Ahmad Masri, director of the Hypertrophic Cardiomyopathy Center at Oregon, said the trial’s dual primary endpoints were changes from baseline in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, or KCCQ-CSS, and peak oxygen consumption, or peak VO2.

KCCQ-CSS improved by a placebo-adjusted 3 points at week 36 in favor of aficamten, with a P value of 0.021. Peak VO2 improved by a placebo-adjusted 0.67 milliliters per kilogram per minute, with a P value of 0.003. New York Heart Association class improvement of at least one class showed a 14% difference favoring aficamten at week 36, with a P value of less than 0.001. The study also reported favorable results for a composite exercise Z-score and for NT-proBNP, a cardiac biomarker. Masri said treatment effects across prespecified subgroup analyses, including patients using beta blockers, those with intracavitary obstruction and those with differing genotype status, were generally consistent in favor of aficamten.

Among other secondary endpoints, aficamten showed an effect on left atrial volume index, though it did not reach statistical significance, with a P value of 0.058. Time to first composite cardiovascular event did not differ between the aficamten and placebo groups.

Responder Analysis and Clinical Context Martin Maron, director of the Hypertrophic Cardiomyopathy Center at Tufts Medical Center, discussed an additional analysis intended to assess clinically meaningful changes for individual patients rather than mean changes across treatment groups.

According to Maron, more than 70% of aficamten-treated patients achieved a prespecified threshold for clinically meaningful symptom improvement, based on improvement in NYHA class and the Patient Global Impression of Change questionnaire. About half achieved a defined improvement in exercise capacity, while more than half showed improvement in left ventricular relaxation and more than 63% had a substantial reduction in BNP.

Maron said more than half of aficamten-treated patients achieved improvement across three or more of the five clinical, functional and biological measures evaluated, compared with 13% of placebo-treated patients. He characterized the findings as evidence of a broad treatment effect in a population with limited treatment options.

Christina Paitazoglou, a cardiologist at University Heart Center in Germany who was not involved in the trial, said nHCM patients remain symptomatic despite current heart-failure-guideline-based care and have lacked a targeted therapy. She noted that the trial’s improvement in peak VO2 was notable because such exercise parameters can be difficult to improve in heart-failure populations.

Safety Findings and Extension Study Masri said aficamten was generally well tolerated, with no new safety signals reported. The least-squares mean difference in left ventricular ejection fraction, or LVEF, was 4.4%. Treatment interruption due to reduced LVEF occurred in 3% of aficamten-treated patients.

Heart failure events occurred in 4.7% of patients receiving aficamten and 1.2% of placebo recipients. Masri said these events occurred during the drug initiation and titration phase and were managed with diuretics and outpatient care. There was no difference between groups in new-onset atrial fibrillation, he said.

Maron said 12 serious heart failure events occurred in the aficamten arm, compared with three in the placebo arm, and stated that all aficamten events occurred during the titration period. He said patients responded to limited heart-failure therapy and that the events appeared unrelated to ejection fraction.

More than 80% of ACACIA-HCM participants elected to enroll in the FOREST-HCM open-label extension study. Maron said longer-term data from FOREST, using a titration approach incorporating echocardiographic assessment and physician judgment, showed a lower incidence of serious heart failure events than in ACACIA-HCM. He also said clinical benefits appeared to be maintained beyond 96 weeks in the extension study.

Regulatory Plans Robert Blum, Cytokinetics’ president and chief executive officer, said the company intends to file its supplemental FDA application for nHCM in the fourth quarter. He said Cytokinetics would provide updates on plans for other geographies during its next earnings call.

Blum also said the company has launched MYKORZA for obstructive HCM in the U.S., Germany and China, and has received approval from the U.K.’s MHRA alongside positive guidance from NICE in the U.K. and Wales.

About Cytokinetics (NASDAQ:CYTK)Cytokinetics, Inc is a late‐stage biopharmaceutical company focused on the discovery and development of novel small‐molecule therapeutics that modulate muscle function. Founded in 1998 and headquartered in South San Francisco, California, the company applies its proprietary insights in muscle biology to address diseases characterized by impaired muscle performance. Its research spans both cardiac and skeletal muscle targets, aiming to deliver innovative medicines for conditions with significant unmet medical need.

The company's most advanced program, omecamtiv mecarbil, is being evaluated for the treatment of heart failure by enhancing cardiac muscle contractility.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].

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Additional Results from ACACIA-HCM Demonstrate Improvements in Cardiac Structure and Diastolic Function in Patients with Non-Obstructive HCM

New Analysis of MAPLE-HCM Finds Aficamten Outperformed Metoprolol Across Pre-Trial Treatment Groups in Patients with Obstructive HCM

SOUTH SAN FRANCISCO, Calif., Aug. 29, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional results from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM) and MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) were presented in a Late Breaking Clinical Session at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany and simultaneously published in Circulation and the Journal of the American College of Cardiology: Heart Failure, respectively.

“The findings from these additional analyses of ACACIA-HCM and MAPLE-HCM elaborate on the primary results from each trial and expand the body of evidence supporting the potential use of aficamten across the spectrum of HCM,” said Stephen Heitner, M.D., Cytokinetics’ Chief Medical Officer. “In particular, the additional results from ACACIA-HCM suggest that the benefits of aficamten in non-obstructive HCM extend beyond exercise capacity and symptom burden to also include improvements in wall thickness and diastolic function, pointing to the potential mechanisms by which aficamten is effective in these patients. Given the lack of approved therapies for non-obstructive HCM, these findings highlight the potential impact aficamten could have on this population independent from relief of left ventricular outflow tract obstruction.”

ACACIA-HCM: Effect of Aficamten on Cardiac Structure and Function in Patients with Symptomatic Non-Obstructive HCM

Results from a pre-specified exploratory analysis of ACACIA-HCM, the Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), were presented in a Late Breaking Clinical Trial Session and simultaneously published in Circulation.1

As previously reported, the primary results from ACACIA-HCM showed that treatment with aficamten was associated with significant improvements from baseline to Week 36 compared to placebo in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance (pVO2). This analysis showed that treatment with aficamten also demonstrated improvements in measures of cardiac structure and diastolic function at the time of the primary analysis (36 weeks) and at end of treatment (EOT) (up to 72 weeks; median time to end of treatment = 49 weeks).

At Week 36 and at EOT, aficamten significantly improved measures of diastolic function including peak E velocity (p=0.001 and p=0.034, respectively) and septal e’ velocity (p<0.001 for both), suggesting improvement in myocardial relaxation and enhanced early diastolic filling. Septal E/e’ showed a trend towards improvement at Week 36 (p=0.07), and a statistically significant improvement at EOT (p<0.001). Similarly, left atrial volume index (LAVI) showed a trend toward stabilization at Week 36 (p=0.06) and a statistically significant improvement with longer treatment exposure at EOT (p=0.022). These results in patients with nHCM show that aficamten improves diastolic function independent of reducing left ventricular outflow tract (LVOT) obstruction, providing support for the importance of diastolic function as the potential underlying mechanism for the improvements in functional capacity and symptom relief in this population.

Aficamten was associated with a modest but statistically significant (p<0.001) reduction in systolic function as measured by left ventricular ejection fraction (LVEF) which remained within normal range at EOT. Left ventricular wall thickness decreased by 0.2 cm at EOT (p<0.001) while left ventricular end-systolic and end-diastolic left ventricular volumes increased (p<0.001).

MAPLE-HCM: Aficamten vs. Metoprolol in Obstructive HCM According to Pre-Trial Treatment

Results of a post-hoc analysis from MAPLE-HCM, the Phase 3 clinical trial of aficamten compared to metoprolol in patients (n=175) with symptomatic obstructive HCM (oHCM), were presented in a Late Breaking Clinical Trial Session and simultaneously published in the Journal of the American College of Cardiology: Heart Failure.2

As previously reported, the primary results of MAPLE-HCM demonstrated superiority of aficamten to metoprolol on pVO2 (change from baseline to Week 24, least squares mean (LSM) treatment difference (SE), +2.3 (0.39) mL/kg/min, p<0.001). This post-hoc analysis evaluated the effect of treatment with aficamten or metoprolol on the primary endpoint and key secondary endpoints according to pre-trial medical therapy.

At screening, 123 patients were taking a beta blocker while 52 patients were not taking a beta blocker. Of the 52 patients not taking a beta blocker at screening, 22 patients had received no standard of care therapy for at least 12 months before screening. Prior to randomization, all patients underwent a two-week washout period of standard of care therapy.

Independent of pre-trial medical therapy, aficamten demonstrated a consistent treatment effect across multiple efficacy endpoints compared with metoprolol. Aficamten improved pVO2 compared with metoprolol for patients not previously taking beta blockers (LSM difference +3.1 mL/kg/min, p<0.001), as well as for patients previously taking beta blockers (LSM difference +1.9 mL/kg/min, p<0.001) with no difference between groups in the improvement (interaction p = 0.133).

Similarly, compared to metoprolol, aficamten significantly improved key secondary endpoints independent of pre-trial treatment, including KCCQ-CSS and New York Heart Association (NYHA) Functional Class, Valsalva left ventricular outflow tract gradient (LVOT-G) and NT-proBNP.

There were no differences in the safety profile of aficamten, including the rates of serious adverse events, between pre-trial treatment groups.

About ACACIA-HCM

ACACIA-HCM was a Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of aficamten compared to placebo in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The dual primary endpoint was the change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score and change in maximal exercise performance (peak VO2) from baseline to Week 36.

Secondary endpoints included the proportion of participants with ≥1 class improvement in NYHA functional class, and changes in the composite z-score of two cardiopulmonary exercise testing (CPET) parameters of sub-maximal exercise performance (VE/VCO2 and pVO2), NT-proBNP, and left atrial volume index (LAVI) from baseline to Week 36. After 36 weeks of treatment, participants continued treatment with aficamten or placebo for up to 72 weeks to evaluate additional secondary and exploration analyses including the time to first cardiovascular event. The trial (outside Japan) concluded when at least 200 patients completed 52 weeks of treatment.

ACACIA-HCM randomized and treated 517 participants (outside Japan) on a 1:1 basis with aficamten or placebo. Randomization was stratified by persistent atrial fibrillation and presence of intracavitary obstruction. At screening, participants enrolled in ACACIA-HCM were required to have resting left ventricular outflow tract gradient (LVOT-G) <30 mmHg and post-Valsalva LVOT-G <50 mmHg in addition to left ventricular ejection fraction (LVEF) ≥60%, respiratory exchange ratio (RER) ≥1.00 and peak VO2 ≤90% predicted, NT-proBNP ≥300 pg/mL or ≥900 pg/mL if atrial fibrillation or atrial flutter were present at screening, NYHA functional class II or III and KCCQ Clinical Summary Score ≤85.

Each patient received up to four escalating doses of aficamten or placebo based on echocardiographic guidance. Participants who received aficamten began with 5 mg dosed once daily. At weeks 2, 4 and 6 participants received an echocardiogram to determine if they would be up-titrated to escalating doses of 10, 15 or 20 mg. Dose escalation occurred only if a participant had an LVEF ≥60%. Participants who did not meet escalation criteria continued the same dose or were down-titrated if their LVEF was <50%.

About MAPLE-HCM

MAPLE-HCM was a Phase 3, multi-center, randomized, double-blind active-comparator clinical trial of aficamten compared to metoprolol in patients with symptomatic obstructive HCM (oHCM). The primary endpoint was the change in peak oxygen uptake (pVO2) from baseline to Week 24 measured by cardiopulmonary exercise testing (CPET). Secondary endpoints include the change from baseline to Week 24 in Kansas City Cardiomyopathy Questionnaire (KCCQ) score, the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class, and changes in left ventricular mass index (LVMI), left atrial volume index (LAVI), post-Valsalva left ventricular outflow tract gradient (LVOT-G) and NT-proBNP.

MAPLE-HCM enrolled 175 patients, randomized on a 1:1 basis to receive aficamten or metoprolol as monotherapy in a double-blind, double dummy fashion. Randomization was stratified by CPET exercise modality (treadmill or bicycle) and recently diagnosed versus chronic obstructive HCM. At screening, patients enrolled in MAPLE-HCM had a resting LVOT-G ≥30 mmHg and/or post-Valsalva LVOT-G ≥50 mmHg in addition to left ventricular ejection fraction (LVEF) ≥ 60%, respiratory exchange ratio (RER) ≥ 1.05 and pVO2 <100% predicted, NYHA functional class II or III and a KCCQ Clinical Summary Score (KCCQ-CSS) score ≥ 35 and ≤ 90. Following the initial screening visit, all participants on standard of care (SOC) therapy underwent a washout period of up to 14 days to wean from SOC therapy, followed by an additional 7 days with no SOC therapy prior to the second screening visit. Each patient received up to four escalating doses of aficamten or metoprolol based on echocardiographic guidance as well as a matching placebo for the alternate therapy.

About MYQORZO® (aficamten)

MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union and United Kingdom for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.3

Aficamten is also under clinical investigation in CEDAR-HCM in a pediatric population with oHCM. Safety and efficacy of aficamten have not been established in a pediatric patient population. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study.

INDICATION

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILUREMYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction.

Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program.

CONTRAINDICATIONS

MYQORZO is contraindicated with concomitant use of rifampin.

WARNINGS AND PRECAUTIONS

Heart Failure

MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure.
Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure.

Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure.

Initiation of MYQORZO in patients with LVEF <55% is not recommended.

MYQORZO REMS Program

MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction.

Notable requirements of the MYQORZO REMS Program include:

Prescribers must be certified by enrolling in the MYQORZO REMS ProgramPatients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirementsPharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZOWholesalers and distributors must only distribute to certified pharmacies Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367.

Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness

MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (eg, fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (eg, rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly.

Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment.

ADVERSE REACTIONS

Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial.

INDICATIONS AND USAGE

MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

Please see full Prescribing Information approved in the U.S., including Boxed WARNING.

Please see full Summary of Product Characteristics approved in the European Union.

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. HCM can be obstructive, when thickened muscle blocks blood flow, or non-obstructive, when blood flow is not blocked but heart function is still affected. In obstructive HCM, the thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller, stiffer and less able to relax and fill with blood. Ultimately, HCM limits the heart’s pumping function, leading to reduced exercise capacity and a variety of symptoms.

HCM is the most common monogenic inherited cardiovascular disorder, affecting approximately 1 out of 350 individuals worldwide.4

Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).5

People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.6 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.7 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the approved in the U.S., China, European Union and United Kingdom for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). 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. Examples of such statements include, but are not limited to, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. 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 C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S., the European Union and the United Kingdom.

References

Maron MS, et al. Global Efficacy of Aficamten in Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM. Circ. 2026Dominguez, F. Efficacy of Aficamten vs Metoprolol According to Pretrial Beta-Blocker Treatment in Obstructive Hypertrophic Cardiomyopathy. JACC: HF. 2026.Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4;27:200485. doi: 10.1016/j.ijcrp.2025.200485Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260.Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

Hot Line Presentation of Primary Results from ACACIA-HCM to Elaborate on Positive Topline Results in Patients with Non-Obstructive Hypertrophic Cardiomyopathy

Company to Host In-Person and Virtual Investor Event to Discuss Results from
Late-Breaking Science Presentations

SOUTH SAN FRANCISCO, Calif., Aug. 20, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced upcoming presentations, including a Hot Line presentation and two Late Breaking Science presentations, at the European Society of Cardiology (ESC) Congress, taking place August 28-31 in Munich, Germany.

Hot Line and Late-Breaking Science Presentations

Title: ACACIA-HCM: Aficamten for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
Presenter: Ahmad Masri, M.D., M.S., Associate Professor of Medicine, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University
Date: Friday, August 28, 2026
Session Title: Hot Line 1
Session Time: 11:00 AM – 12:18 PM CEST
Presentation Time: 11:45 – 11:58 AM CEST
Location: Munich, Main Auditorium (Hall B3)

Title: Effect of Aficamten on Cardiac Structure and Function in Patients with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy - Results from the ACACIA-HCM Trial
Presenter: Sheila Hegde, M.D., MPH, Assistant Professor, University of Texas Southwestern Medical Center – Dallas, TX and Affiliate Faculty, Brigham and Women's Hospital, Boston, MA
Date: Saturday, August 29, 2026
Session Title: Late-Breaking Clinical Science: Hypertrophic Cardiomyopathy
Session Time: 4:15 – 5:15 PM CEST
Presentation Time: 4:15 – 4:30 PM CEST
Location: Ashgabat (Hall A3)

Title: Aficamten vs. Metoprolol Monotherapy in Obstructive Hypertrophic Cardiomyopathy According to Pre-Trial Treatment in MAPLE-HCM
Presenter: Fernando Dominguez, M.D., Ph.D., Consultant Cardiologist, Hospital Universitario Puerta De Hierro Majadahonda – Madrid, Spain
Date: Saturday, August 29, 2026
Session Title: Late-Breaking Clinical Science: Hypertrophic Cardiomyopathy
Session Time: 4:15 – 5:15 PM CEST
Presentation Time: 4:30 – 4:45 PM CEST
Location: Ashgabat (Hall A3)

Poster Presentations

Title: Impact of Peak Provoked Left Ventricular Outflow Tract Gradients on Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy: A Real-World Cross-Sectional Survey
Presenter: Paulos Gebrehiwet, Ph.D., M.S., Senior Manager, Health Economics and Outcomes Research Europe, Cytokinetics
Session Date: Saturday, August 29, 2026
Session Title: Improving Diagnosis and Treatment in Hypertrophic Cardiomyopathy
Session Time: 8:15 AM – 9:00 AM CEST
Location: Station 12 (Research Gateway – Hall A1)

Title: Real-World Clinical Burden of Obstructive Hypertrophic Cardiomyopathy: A Nationwide Study in France
Presenter: Prof. Albert Hagege, M.D., Ph.D., Director, Cardiovascular Department, European Hospital Georges Pompidou, Paris, France
Session Title: Hypertrophic Cardiomyopathy: Disease Burden, Risk Stratification, and Clinical Outcomes
Session Date: Sunday, August 30, 2026
Session Time: 12:15 PM – 1:00 PM CEST
Location: Exchange Circle 3 (Research Gateway – Hall A1)

Investor Event and Webcast

Cytokinetics will host an in-person investor event in Munich, Germany on August 28, 2026 at 2:00 PM Central European Summer Time (8:00 AM Eastern Time). The event will also be simultaneously webcast live online. Interested parties must register to attend in-person or online at https://acacia-hcm-investor-event-esc-2026.open-exchange.net/registration.

Registered attendees may access the webcast by visiting the Investor & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay will be archived on the Cytokinetics website for six months.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, EU and UK for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to discuss the results with the U.S. FDA and other regulatory authorities. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). 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. Examples of such statements include, but are not limited to, statements relating to the enrollment, expected results or timing of completion of any of our clinical trials, the clinical meaningfulness, persuasiveness or interpretation of clinical trial results, including for purposes of regulatory approval, labeling, or market acceptance, the results of long-term, secondary or exploratory analyses, including analyses of time to first cardiovascular event, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission including the risk factors included in Cytokinetics’ most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S. and the European Union.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

SOUTH SAN FRANCISCO, Calif., Aug. 18, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on August 14, 2026 it granted stock options to purchase an aggregate of 27,565 shares of common stock and 18,273 restricted stock units (RSUs) that will be settled in shares of common stock upon vesting to 12 employees, whose employment commenced in July and August 2026 as a material inducement to their employment.

The RSUs will vest over 3 years, with 40% of the RSUs vesting on the first anniversary of the applicable grant date, an additional 40% of the RSUs vesting on the second anniversary of the grant date and the final 20% vesting on the third anniversary of the grant date, in each case, subject to each respective employee’s continued service with the Company. The stock options that were granted are subject to an exercise price of $74.13 per share, which is equal to the closing price of the Company’s common stock on August 14, 2026 and will vest over 4 years, with 1/4th of the shares underlying the employee’s option vesting on the one-year anniversary of the grant date and the remaining shares thereafter vesting in monthly installments at a rate of 1/48th of the shares underlying such stock options over the subsequent 36 months, subject to each respective employee’s continued service with the Company. The stock options have a 10-year term. These awards are subject to the terms and conditions of the Company's Amended and Restated 2004 Equity Incentive Plan and the applicable award agreements pursuant to which the awards were granted.

The stock options and RSUs were granted as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to discuss the results with the U.S. FDA and other regulatory authorities. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Disclaimer 

Omecamtiv mecarbil and ulacamten are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). 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. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities of Cytokinetics’ product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics' business outlined in Cytokinetics' filings with the Securities and Exchange Commission particularly under the caption “Risk Factors” in Cytokinetics’ latest Annual Report on Form 10-K. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S. and the European Union.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

Cytokinetics, Incorporated (CYTK) Q2 2026 Earnings Call Transcript

Cytokinetics (CYTK - Free Report) came out with a quarterly loss of $1.5 per share versus the Zacks Consensus Estimate of a loss of $1.63. This compares to a loss of $1.12 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +7.98%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.67 per share when it actually produced a loss of $1.67, delivering no surprise.

Over the last four quarters, the company has surpassed consensus EPS estimates two times.

Cytokinetics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $28.62 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 40.20%. This compares to year-ago revenues of $66.77 million. The company has topped consensus revenue estimates three times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Cytokinetics shares have added about 24.1% since the beginning of the year versus the S&P 500's gain of 12.8%.

What's Next for Cytokinetics?While Cytokinetics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Cytokinetics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$1.63 on $30.27 million in revenues for the coming quarter and -$6.20 on $114.87 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

One other stock from the same industry, Gyre Therapeutics, Inc. (GYRE - Free Report) , is yet to report results for the quarter ended June 2026.

This company is expected to post quarterly loss of $0.08 per share in its upcoming report, which represents a year-over-year change of -500%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

Gyre Therapeutics, Inc.'s revenues are expected to be $26.24 million, down 2% from the year-ago quarter.

Britain's medicines regulator approved Cytokinetics' drug for a rare heart condition on Thursday, with the country's cost-effectiveness watchdog ​recommending it for NHS reimbursement, potentially reaching about 6,600 ‌patients.

SOUTH SAN FRANCISCO, Calif., July 17, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on July 15, 2026 it granted stock options to purchase an aggregate of 21,220 shares of common stock and 14,067 restricted stock units (RSUs) that will be settled in shares of common stock upon vesting to 10 employees, whose employment commenced in June and July 2026 as a material inducement to their employment.

The RSUs will vest over 3 years, with 40% of the RSUs vesting on the first anniversary of the applicable grant date, an additional 40% of the RSUs vesting on the second anniversary of the grant date and the final 20% vesting on the third anniversary of the grant date, in each case, subject to each respective employee’s continued service with the Company. The stock options that were granted are subject to an exercise price of $82.62 per share, which is equal to the closing price of the Company’s common stock on July 15, 2026 and will vest over 4 years, with 1/4th of the shares underlying the employee’s option vesting on the one-year anniversary of the grant date and the remaining shares thereafter vesting in monthly installments at a rate of 1/48th of the shares underlying such stock options over the subsequent 36 months, subject to each respective employee’s continued service with the Company. The stock options have a 10-year term. These awards are subject to the terms and conditions of the Company's Amended and Restated 2004 Equity Incentive Plan and the applicable award agreements pursuant to which the awards were granted.

The stock options and RSUs were granted as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to discuss the results with the U.S. FDA and other regulatory authorities. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Disclaimer 

Omecamtiv mecarbil and ulacamten are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). 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. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities of Cytokinetics’ product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics' business outlined in Cytokinetics' filings with the Securities and Exchange Commission particularly under the caption “Risk Factors” in Cytokinetics’ latest Annual Report on Form 10-K. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S. and the European Union.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

Cytokinetics (CYTK - Free Report) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.

A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.

The power of a changing earnings picture in determining near-term stock price movements makes the Zacks rating system highly useful for individual investors, since it can be difficult to make decisions based on rating upgrades by Wall Street analysts. These are mostly driven by subjective factors that are hard to see and measure in real time.

Therefore, the Zacks rating upgrade for Cytokinetics basically reflects positivity about its earnings outlook that could translate into buying pressure and an increase in its stock price.

Most Powerful Force Impacting Stock PricesThe change in a company's future earnings potential, as reflected in earnings estimate revisions, and the near-term price movement of its stock are proven to be strongly correlated. The influence of institutional investors has a partial contribution to this relationship, as these big professionals use earnings and earnings estimates to calculate the fair value of a company's shares. An increase or decrease in earnings estimates in their valuation models simply results in higher or lower fair value for a stock, and institutional investors typically buy or sell it. Their transaction of large amounts of shares then leads to price movement for the stock.

For Cytokinetics, rising earnings estimates and the consequent rating upgrade fundamentally mean an improvement in the company's underlying business. And investors' appreciation of this improving business trend should push the stock higher.

Harnessing the Power of Earnings Estimate RevisionsAs empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock movements, tracking such revisions for making an investment decision could be truly rewarding. Here is where the tried-and-tested Zacks Rank stock-rating system plays an important role, as it effectively harnesses the power of earnings estimate revisions.

The Zacks Rank stock-rating system, which uses four factors related to earnings estimates to classify stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record, with Zacks Rank #1 stocks generating an average annual return of +25% since 1988. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here >>>> .

Earnings Estimate Revisions for CytokineticsFor the fiscal year ending December 2026, this biopharmaceutical company is expected to earn -$6.22 per share, which is unchanged compared with the year-ago reported number.

Analysts have been steadily raising their estimates for Cytokinetics. Over the past three months, the Zacks Consensus Estimate for the company has increased 1.3%.

Bottom LineUnlike the overly optimistic Wall Street analysts whose rating systems tend to be weighted toward favorable recommendations, the Zacks rating system maintains an equal proportion of "buy" and "sell" ratings for its entire universe of more than 4,000 stocks at any point in time. Irrespective of market conditions, only the top 5% of the Zacks-covered stocks get a "Strong Buy" rating and the next 15% get a "Buy" rating. So, the placement of a stock in the top 20% of the Zacks-covered stocks indicates its superior earnings estimate revision feature, making it a solid candidate for producing market-beating returns in the near term.

You can learn more about the Zacks Rank here >>>

The upgrade of Cytokinetics to a Zacks Rank #2 positions it in the top 20% of the Zacks-covered stocks in terms of estimate revisions, implying that the stock might move higher in the near term.

Key Takeaways Cytokinetics launched Myqorzo in the US and Germany after FDA and European Commission approvals.CYTK seeks to expand Myqorzo's label as the FDA reviews its MAPLE-HCM supplemental application.CYTK reported positive phase III ACACIA-HCM results supporting aficamten in non-obstructive HCM. Cytokinetics, Incorporated (CYTK - Free Report) has entered a pivotal phase following the FDA approval of its first drug, Myqorzo (aficamten), for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

The approval marks the company’s transition into a commercial-stage biotech.

Myqorzo is an allosteric and reversible inhibitor of cardiac myosin motor activity.  It is approved in the United States and China for the treatment of adults with symptomatic oHCM.

The commercial outlook for Myqorzo appears promising. The company initiated the U.S. commercial rollout in January 2026. Early launch metrics indicate strong physician engagement and patient uptake, with over 275 unique healthcare providers prescribing the drug and approximately 680 patients being prescribed Myqorzo by the end of the first quarter.

More than 70% of patients on therapy transitioned to paid prescriptions.

International expansion provides an additional growth lever. The European Commission approval in February 2026 further expands Myqorzo's addressable market.

Cytokinetics recently achieved an important commercial milestone with the first European launch of Myqorzo in Germany, marking the drug's entry into the EU market.

CYTK is also working on a label expansion of Myqorzo. The FDA accepted its supplemental new drug application for MAPLE-HCM, a phase III study of aficamten as monotherapy compared with metoprolol as monotherapy in patients with oHCM. The regulatory body assigned a target action date of Nov. 14, 2026.

Meanwhile, aficamten continues to be evaluated across additional patient populations, supporting potential lifecycle expansion opportunities. The drug was studied in the phase III ACACIA-HCM study in non-obstructive hypertrophic cardiomyopathy (nHCM).

The ACACIA-HCM study successfully met both co-primary endpoints, demonstrating statistically significant improvements from baseline through week 36 in both Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score and maximal exercise performance (peak VO2). Statistically significant improvements compared to placebo were also observed in key secondary endpoints.

The company’s tailored commercialization model, including dedicated cardiac account specialists and patient support programs, may further drive uptake.

Competition for CYTK’s MyqorzoMyqorzo operates within an evolving treatment landscape for oHCM. Its primary branded competitor is Camzyos, a cardiac myosin inhibitor marketed by Bristol Myers Squibb (BMY - Free Report) . In addition to this direct competition, Myqorzo faces established generic therapies, namely beta blockers and calcium channel blockers, which continue to serve as the first-line standard of care.

BMY obtained FDA approval for Camzyos in 2022 for the treatment of adults with symptomatic New York Heart Association class II-III obstructive HCM to improve functional capacity and symptoms.

The drug continues to gain traction in the targeted market, supported by growing demand and increased adoption among eligible patients

The FDA accepted BMY’s supplemental new drug application seeking approval of Camzyos for the treatment of adolescentsaged 12 to under 18 years with symptomatic oHCM.

A potential competitor for Cytokinetics is Edgewise Therapeutics, Inc. (EWTX - Free Report) , whose cardiovascular program includes novel, oral, selective cardiac sarcomere modulators — EDG-7500 and EDG-15400.

Edgewise recently reported top-line results from the 12-week phase II Part D CIRRUS-HCM study of EDG-7500 in oHCM and nHCM.  Consistent and clinically meaningful improvements were observed in echocardiogram parameters, biomarkers, symptoms and functional status across obstructive and nonobstructive HCM.

EWTX expects to initiate a phase II study on EDG-15400 in participants with heart failure with preserved ejection fraction in the second half of 2026.  

CYTK’s Price Movement, Valuation and EstimatesCytokinetics’ shares have gained 35.5% year to date compared with the industry’s 6.3% growth.

Image Source: Zacks Investment Research

Going by the price/sales ratio, CYTK’s shares currently trade at 40.74X forward sales, higher than the industry’s average of 1.90X but lower than its mean of 49.04X.

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for 2026 loss per share has narrowed to $6.22 from $6.36 and that for 2027 has narrowed to $4.59 from $4.62 in the past 60 days.

Image Source: Zacks Investment Research

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Large-cap pharma is back in the deal market. AbbVie’s (NASDAQ: ABBV | ABBV Price Prediction) pending acquisition of Apogee Therapeutics signaled that big buyers will pay up for de-risked clinical assets. Patent cliffs approach, GLP-1 franchises crowd in, and cardio and endocrine portfolios at majors look thin. That backdrop puts a handful of under-followed biotech names squarely in the crosshairs.

Credible takeover targets need:

An approved or launching commercial product with traction Differentiated platform or franchise assets Manageable market cap Clear strategic fit with a likely acquirer A clean balance sheet Near-term catalysts to justify a bid premium No deals have been announced for the three names below. Here we rank which biotech is the cleanest fit for the next pharma buying spree.

3. Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals (NASDAQ: ARWR) sits at the strategic top of this list yet ranks third on acquirability. The RNAi platform company has crossed into commercial stage with Redemplo (plozasiran), FDA-approved for familial chylomicronemia syndrome at a $45,000 WAC per year, with more than 400 total prescriptions and roughly 30 new weekly scripts, of which 85% are naive to the APOC3 class.

The obesity readouts are what large pharma wants. ARO-INHBE delivered 9.4% weight loss at week 16 combined with tirzepatide, roughly double tirzepatide alone, alongside 76.7% liver fat reduction. Arrowhead carries $1.78 billion in cash following a $930 million capital raise, and recently locked in a Novartis ARO-SNCA Parkinson’s deal worth $200 million upfront.

The catch is price. Shares are up 400.0% over the past year to $79.81, with a market cap near $11.2 billion. A platform this broad is more likely to keep signing partnerships than to sell outright.

2. Cytokinetics Cytokinetics (NASDAQ: CYTK) has been a perennial cardiovascular takeout name. The case strengthened with the December 2025 FDA approval of MYQORZO (aficamten) in obstructive hypertrophic cardiomyopathy. The first commercial quarter delivered $4.79 million in net product revenue across roughly 680 patients, with more than 1,400 HCPs REMS certified and EU plus China NMPA approvals already in hand.

The pipeline got a boost when ACACIA-HCM met both dual primary endpoints (KCCQ and peak VO2) in non-obstructive HCM, opening the door to the entire HCM spectrum. The MAPLE-HCM sNDA carries a PDUFA date of November 14, 2026. Bayer and Sanofi are already partnered regionally, a familiar pattern for eventual buyers.

The setup is coveted but expensive. Shares closed at $81.20, up 143.1% over the past year, leaving a market cap near $11.0 billion and a forward multiple around 118x. The asset is a genuine strategic prize for Bristol Myers Squibb, Novartis, or Bayer, but any buyer pays up. Analyst targets sit at $105.60, hinting at where a deal premium might start.

1. Crinetics Pharmaceuticals Crinetics Pharmaceuticals (NASDAQ: CRNX) has the cleanest biotech takeover setup of the trio. It is the smallest at a $3.8 billion market cap, and the only one whose stock has compressed, with shares at $36.18 and down 22.3% year to date despite a meaningful commercial ramp.

Palsonify (paltusotine) is the first once-daily oral acromegaly therapy, displacing legacy injectable somatostatin analogs. The drug now has FDA approval, EC approval across all 27 EU member states in April 2026, an NDA filed in Japan via SKK, and a Brazil MAA submitted. Q1 net product revenue hit $10.31 million, nearly double the prior quarter, with 263 unique prescribers and roughly 70% of patients on reimbursed therapy.

Late-stage atumelnant adds a second engine, with Phase 2/3 trials initiating in ACTH-dependent Cushing’s syndrome and pediatric CAH, where atumelnant produced a 67% reduction in androstenedione and brought 88% of CAH patients down to physiologic glucocorticoid levels. The balance sheet is the strongest of the three, with positive shareholders’ equity of $1.28 billion after a $380 million net equity raise in January 2026. An $83.14 mean price target reflects the bullish Wall Street sentiment on the stock.

Strategically, Crinetics is a pure endocrine specialist. That maps cleanly onto Novartis, Ipsen, and Recordati, all of which compete in acromegaly and broader endocrine markets. A de-risked commercial launch, depressed share price, bolt-on size, and multiple Phase 3 catalysts make it the most digestible deal in the group.

The Bottom Line Pharma’s deal appetite is back and will favor mid-cap biotech names with approved products and clean strategic fit. Arrowhead is too rich and too platform-heavy to sell whole. Cytokinetics is the high-quality but expensive prize. Crinetics offers a launching commercial asset, compressed valuation, and bolt-on cap size. None has announced a deal. As a setup-ranking exercise, Crinetics fits the typical specialty-pharma acquisition template most cleanly.

SOUTH SAN FRANCISCO, Calif., June 17, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on June 15, 2026 it granted stock options to purchase an aggregate of 24,784 shares of common stock and 16,429 restricted stock units (RSUs) that will be settled in shares of common stock upon vesting and 2,242 performance stock units (PSUs) that, if earned, will be settled in shares of common stock upon vesting to 12 employees, whose employment commenced in May and June, 2026, as a material inducement to their employment.

The RSUs will vest over 3 years, with 40% of the RSUs vesting on the first anniversary of the applicable grant date, an additional 40% of the RSUs vesting on the second anniversary of the grant date and the final 20% vesting on the third anniversary of the grant date, in each case, subject to each respective employee’s continued service with the Company. The stock options that were granted are subject to an exercise price of $71.38 per share, which is equal to the closing price of the Company’s common stock on June 15, 2026, and will vest over 4 years, with 1/4th of the shares underlying the employee’s option vesting on the one-year anniversary of the grant date and the remaining shares thereafter vesting in monthly installments at a rate of 1/48th of the shares underlying such stock options over the subsequent 36 months, subject to each respective employee’s continued service with the Company. The stock options have a 10-year term. The PSU award is subject to two performance goals and will be earned as to up to 50% of the number of shares subject to the PSU award upon the certification by Compensation and Talent Committee of the Company’s Board of Directors (Committee) that the Company has achieved the first performance goal and as to up to 50% of the number of shares subject to the PSU award upon the certification by the Committee that the Company has achieved the second performance goal. The earned shares will vest as to 50% of the earned shares on applicable Committee certification date and as to 50% of the earned shares following the one-year anniversary of the applicable Committee certification date, subject to the respective employee’s continued service with the Company. These awards are subject to the terms and conditions of the Company's Amended and Restated 2004 Equity Incentive Plan and the applicable award agreements pursuant to which the awards were granted.

The stock options, RSUs and PSUs were granted as material inducements to employment in accordance with Nasdaq Listing Rule 5635(c)(4).

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company is preparing to present the full results at an upcoming medical meeting and discuss them with the U.S. FDA and other regulatory authorities. Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Disclaimer 

Omecamtiv mecarbil and ulacamten are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). 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. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' and its partners' research and development activities of Cytokinetics’ product candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics' business outlined in Cytokinetics' filings with the Securities and Exchange Commission particularly under the caption “Risk Factors” in Cytokinetics’ latest Annual Report on Form 10-K. Forward-looking statements are not guarantees of future performance, and Cytokinetics' actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in the U.S. and the European Union.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757 (415) 290-7757

SOUTH SAN FRANCISCO, Calif., May 05, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced plans to offer, subject to market and other conditions, approximately $650 million of shares of its common stock in an underwritten public offering. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Cytokinetics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering. All of the shares of common stock in the offering will be sold by Cytokinetics.

Morgan Stanley, Goldman Sachs & Co. LLC, J.P. Morgan and Jefferies are acting as joint book-running managers for the offering.

The securities described above are being offered by Cytokinetics pursuant to a shelf registration statement (including a base prospectus) filed on February 27, 2025 with the Securities and Exchange Commission (SEC), which has become automatically effective. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website at http://www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by telephone at 866-718-1649 or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, by telephone at (866) 471-2526 or by email at [email protected]; J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by email at [email protected] and [email protected]; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). 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. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ expectations regarding the completion, timing and size of the proposed offering. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, risks and uncertainties related to whether or not Cytokinetics will be able to raise capital through the sale of its securities, the final terms of the proposed offering, market and other conditions, and the satisfaction of customary closing conditions related to the proposed public offering. There can be no assurance that Cytokinetics will be able to complete the proposed public offering on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the proposed public offering, Cytokinetics and its business can be found under the heading “Risk Factors” in Cytokinetics’ Annual Report on Form 10-K for the year ended December 31, 2025, which was filed on February 26, 2026, Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, which was filed on May 5, 2026, and other filings with the SEC, and in the preliminary prospectus supplement related to the proposed public offering to be filed with the SEC on or about the date hereof. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

Cytokinetics, Incorporated (CYTK) Q1 2026 Earnings Call Prepared Remarks Transcript