SOUTH SAN FRANCISCO, Calif., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Robert I. Blum, President and Chief Executive Officer, is scheduled to present at the 44th Annual J.P. Morgan Healthcare Conference on Monday, January 12, 2026 at 9:45 AM Pacific Time in San Francisco, CA. Interested parties may access the live webcast of the presentation by visiting the Investors & Media section of the Cytokinetics website at http://www.cytokinetics.com. The webcast ...

SOUTH SAN FRANCISCO, Calif., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that on December 15, 2025 it granted stock options to purchase an aggregate of 21,399 shares of common stock and 14,422 restricted stock units (RSUs) that will be settled in shares of common stock upon vesting to 10 employees, whose employment commenced in November and December 2025 as a material inducement to their employment.The RSUs will vest over 3 years, with 40% of the RSUs vesting o ...

Core Viewpoint - Cytokinetics reported a narrower net loss in Q3 2025 compared to previous estimates, but revenues fell short of expectations, leading to a mixed outlook for the company as it prepares for upcoming regulatory decisions regarding its lead drug candidate, aficamten [2][3][4]. Financial Performance - The net loss for Q3 2025 was $1.54 per share, which was better than the Zacks Consensus Estimate of a loss of $1.59, but worse than the loss of $1.36 per share reported in the same quarter last year [2]. - Revenues for the quarter totaled $1.9 million, missing the Zacks Consensus Estimate of $6 million, but showing an increase from $0.4 million in the year-ago quarter [3]. - R&D expenses rose by 17.3% year-over-year to $99.2 million, driven by clinical trial advancements and higher personnel costs [4]. - General and administrative expenses increased by 22.6% to $69.4 million, attributed to investments in the commercial readiness of aficamten and personnel-related expenses [4]. - As of September 30, 2025, the company had approximately $1.25 billion in cash and investments, up from $1.04 billion at June 30, 2025 [4]. Drug Development Updates - Aficamten, a cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy (HCM), has had its FDA target action date extended to December 26, 2025 [5]. - Cytokinetics participated in a late-cycle meeting with the FDA regarding aficamten's NDA, discussing its proposed Risk Evaluation and Mitigation Strategy (REMS) [6]. - The company is also addressing questions from the EMA regarding aficamten's marketing authorization application, with a potential decision expected in the first half of 2026 [7]. - Aficamten is being evaluated in multiple clinical trials, including MAPLE-HCM, which reported positive top-line results, and ACACIA-HCM, with results expected in Q2 2026 [8][9]. Pipeline Candidates - Other pipeline candidates include omecamtiv mecarbil, currently in a phase III trial for heart failure, and ulacamten, which is in a phase II trial for heart failure with preserved ejection fraction [10][11]. Market Sentiment and Outlook - Since the earnings release, there has been a downward trend in fresh estimates, with the consensus estimate shifting by 8.51% [12]. - Cytokinetics has a subpar Growth Score of D and a Momentum Score of B, but an overall VGM Score of F, indicating challenges in value [13]. - The stock has a Zacks Rank of 3 (Hold), suggesting an expectation of in-line returns in the coming months [14].

Core Insights - Cytokinetics, Inc. supports a three-year initiative by the American Heart Association to improve care for hypertrophic cardiomyopathy (HCM), addressing disparities in access, diagnosis, and treatment [1][2][3] - HCM affects approximately one in 500 people in the U.S., with many remaining undiagnosed or untreated until severe symptoms arise, leading to fragmented care systems [2][3] - The initiative aims to identify systemic barriers and enhance the identification, assessment, referral, and treatment processes for HCM patients [2][3] Company Commitment - Cytokinetics emphasizes its dedication to the HCM community, aligning its support with its patient-centric culture and scientific focus [2][3] - The company has been actively involved in HCM research and advocacy, collaborating with various stakeholders to improve disease awareness and care pathways [3][5] Initiative Goals - The initiative will increase participation in a national HCM Registry, broaden certification opportunities for healthcare providers, introduce patient support services, and pilot an HCM detection algorithm to reduce underdiagnosis [6]

Core Insights - Cytokinetics is progressing towards the PDUFA date of December 26, 2025, for aficamten, a cardiac myosin inhibitor aimed at treating obstructive hypertrophic cardiomyopathy (HCM) [1][3] - The company reported a strong financial position with approximately $1.25 billion in cash, cash equivalents, and investments as of September 30, 2025 [1][12] - Aficamten has shown promising clinical trial results, demonstrating superiority over metoprolol in improving exercise capacity and cardiac function in patients with obstructive HCM [3][4] Regulatory and Clinical Developments - The company is actively supporting the NDA review for aficamten by the FDA and has engaged in discussions regarding its Risk Evaluation and Mitigation Strategy (REMS) [3] - Aficamten is also under review in the European Union and China, with a potential EMA decision expected in the first half of 2026 [3] - The MAPLE-HCM trial results presented at the European Society of Cardiology Congress 2025 showed a significant improvement in peak oxygen uptake (pVO2) with aficamten compared to metoprolol [3][4] Financial Performance - Total revenues for Q3 2025 were $1.9 million, a significant increase from $0.5 million in Q3 2024 [9] - Research and Development (R&D) expenses for Q3 2025 were $99.2 million, up from $84.6 million in the same period last year, primarily due to advancing clinical trials [10] - The net loss for Q3 2025 was $306.2 million, compared to a net loss of $160.5 million in Q3 2024, which included a debt conversion expense of $121.2 million [14][25] Corporate Developments - James M. Daly has been appointed to the Board of Directors, bringing expertise in commercialization [7] - The company is enhancing its commercial readiness for aficamten, including sales force training and payer engagement [4][3] Future Guidance - The company updated its full-year 2025 financial guidance, projecting GAAP operating expenses between $680 million and $700 million [15][16] - The anticipated increase in operating expenses is attributed to investments in commercial readiness for aficamten's potential approval and launch [16]

Core Insights - Cytokinetics is participating in investor conferences in November 2025, providing opportunities for stakeholders to engage with the management team [1][6]. Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [2]. - The company is preparing for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor, following positive results from the SEQUOIA-HCM Phase 3 clinical trial for obstructive hypertrophic cardiomyopathy (HCM) [2]. - Additional clinical trials are ongoing for aficamten in both obstructive and non-obstructive HCM [2]. - Cytokinetics is also developing omecamtiv mecarbil for heart failure with severely reduced ejection fraction (HFrEF), ulacamten for heart failure with preserved ejection fraction (HFpEF), and CK-089 for specific muscular dystrophies and impaired skeletal muscle function [2].

Core Insights - Cytokinetics is set to report its third quarter results on November 5, 2025, at 4:00 PM Eastern Time, followed by a conference call at 4:30 PM to discuss financial results and business updates [1][2] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [3] - The company is preparing for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor, after positive results from the SEQUOIA-HCM Phase 3 clinical trial for obstructive hypertrophic cardiomyopathy (HCM) [3] - Aficamten is also being evaluated in additional clinical trials for both obstructive and non-obstructive HCM [3] - Cytokinetics is developing omecamtiv mecarbil, a cardiac myosin activator for heart failure with severely reduced ejection fraction (HFrEF), and ulacamten, a cardiac myosin inhibitor for heart failure with preserved ejection fraction (HFpEF) [3] - The company is also working on CK-089, a fast skeletal muscle troponin activator, which may have therapeutic applications for specific muscular dystrophies and other conditions affecting skeletal muscle function [3]

Core Insights - Cytokinetics, Inc. (CYTK) has experienced significant volatility in 2025, with a delay in FDA approval for aficamten being a major setback, but recent positive data has boosted investor confidence [1][8]. Group 1: Aficamten's Clinical Data - Aficamten, a selective cardiac myosin inhibitor, demonstrated superiority over the standard beta-blocker metoprolol across all clinically relevant efficacy endpoints in the MAPLE-HCM study [2][3]. - The drug showed significant improvements in symptoms, functional class, and left ventricular outflow tract (LVOT) gradients compared to metoprolol, indicating a substantial reduction in patient symptom burden [3][4]. - Additional data revealed that aficamten improved cardiac structure and function, with an annual incidence rate of atrial fibrillation at 1.5%, consistent with its safety profile [5][10]. Group 2: FDA Approval Process - The FDA extended the target action date for aficamten's new drug application (NDA) to December 26, 2025, due to a request for a Risk Evaluation and Mitigation Strategy (REMS) submission [8][9]. - This extension was classified as a major amendment, but no additional clinical data or studies were requested by the FDA [9][10]. - The delay is particularly impactful as CYTK currently lacks any approved products in its portfolio, and aficamten will face competition from Bristol Myers Squibb's Camzyos (mavacamten) upon approval [11]. Group 3: Collaboration and Financial Aspects - Cytokinetics entered a collaboration and license agreement with Bayer for the exclusive development and commercialization of aficamten in Japan, which includes an upfront payment of €50 million and potential milestone payments totaling €490 million [6][7]. Group 4: Other Pipeline Candidates - Other candidates in Cytokinetics' pipeline include omecamtiv mecarbil, currently in a phase III trial for heart failure, with enrollment expected to close in late 2026 [13]. - The company has also initiated a phase II trial for ulacamten in patients with heart failure with preserved ejection fraction, with completion of initial cohort enrollment expected in the second half of 2025 [14].

Core Points - Cytokinetics has announced the eighth annual Communications Grant Program aimed at supporting patient advocacy organizations focused on hypertrophic cardiomyopathy (HCM) and heart failure [2][3] - The program will award five grants to enhance communications, awareness, and community engagement within these patient communities [2][3] - The deadline for applications is November 3, 2025, with grant recipients to be announced in January 2026 [4] Group 1: Grant Program Details - The Communications Grant Program addresses a persistent funding gap in communications for patient advocacy organizations, which can hinder patient access to vital resources [3] - Grants may support programming or personnel, depending on the specific needs of the organizations [3] - Eligible organizations must be nonprofit or registered charities in the U.S., Canada, Europe, or the U.K., and serve HCM or heart failure patient communities [4] Group 2: Impact and Evaluation - Applications will be evaluated based on alignment with selection criteria, and recipients must provide an outcomes report to measure the impact of the funding [4] - The 2025 grant recipients include AICARM APS, HeartBrothers Foundation, HeartCharged Corporation, Hypertrophic Cardiomyopathy Association, and Stichting Cardiomyopathie Onderzoek Nederland [3] Group 3: Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology and is advancing a pipeline of potential new medicines for cardiac muscle dysfunction [5] - The company is preparing for potential regulatory approvals for aficamten, a cardiac myosin inhibitor, following positive results from the SEQUOIA-HCM Phase 3 clinical trial [5] - Other investigational medicines in development include omecamtiv mecarbil, ulacamten, and CK-089, targeting various heart failure and muscular dystrophy conditions [5]

Core Insights - Cytokinetics is scheduled to present a corporate update at the Stifel 2025 Virtual Cardiometabolic Forum on September 30, 2025 [1] - The company is advancing a pipeline of potential new medicines for cardiac muscle dysfunction, including aficamten, a cardiac myosin inhibitor, which is nearing regulatory approvals following positive Phase 3 trial results [3] - Cytokinetics is also developing other treatments such as omecamtiv mecarbil for heart failure with reduced ejection fraction, ulacamten for heart failure with preserved ejection fraction, and CK-089 for muscular dystrophy [3] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology [3] - The company focuses on innovative treatments for patients suffering from diseases related to cardiac muscle dysfunction [3] - Aficamten is currently being evaluated in additional clinical trials for both obstructive and non-obstructive hypertrophic cardiomyopathy [3]