SOUTH SAN FRANCISCO, Calif., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the appointment of James M. Daly to its Board of Directors effective August 19, 2025. Mr. Daly brings over 30 years of global biopharmaceutical leadership experience with particular expertise in commercialization to the Company’s Board of Directors. “Jim has longstanding expertise leading commercial launches of innovative therapies, coupled with extensive Board experience guiding later-st ...

Financial Data and Key Metrics Changes - Royalty Pharma reported a 20% growth in portfolio receipts, reaching $727 million, and an 11% growth in royalty receipts to $672 million, exceeding previous guidance [5][18] - The company raised its full-year 2025 top-line guidance for portfolio receipts to a range of $3.05 billion to $3.15 billion, reflecting a growth of approximately 9% to 12% [7][23] Business Line Data and Key Metrics Changes - The strong performance in royalty receipts was driven by key products such as Voronego, Trelegy, Evrysdi, and Tremfya [17] - A one-time payment of approximately $50 million contributed to the growth in portfolio receipts [18] Market Data and Key Metrics Changes - The company highlighted the significant unmet need in pancreatic cancer, with around 56,000 new diagnoses annually, emphasizing the potential market for the oncology therapy Daraxonrezib [14] - The partnership with Revolution Medicines is expected to provide up to $2 billion in funding, indicating a strong market opportunity for innovative therapies [10][12] Company Strategy and Development Direction - Royalty Pharma aims to be a leading partner in funding innovation in life sciences, as evidenced by the groundbreaking collaboration with Revolution Medicines [6][10] - The company is focused on maintaining a diversified portfolio and capitalizing on new funding paradigms to support innovative biotech companies [6][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering strong financial performance for 2025, supported by the updated guidance and the successful execution of their strategy [25][27] - The company is actively exploring additional partnerships and investments, particularly in emerging markets like China [42][44] Other Important Information - Royalty Pharma has access to approximately $3.4 billion in cash and equivalents, providing significant financial capacity to execute its strategy [21] - The company has initiated a dispute resolution process with Vertex regarding royalty payments, which may impact future revenue [26][72] Q&A Session Summary Question: Interest in Revolution Medicines deal and future capacity for similar deals - Management confirmed the excitement around the Revolution Medicines transaction and indicated the capacity to engage in more similar deals in the future [38][39] Question: Royalty opportunities in China - Management acknowledged the growing innovation in China and expressed interest in developing relationships with emerging companies in the region [42][44] Question: Bladder cancer market exposure and royalty tracking - Management did not disclose specific royalty figures for adstilodrine but expressed optimism about the market's growth despite upcoming competitors [48][52] Question: Operating expenses and share repurchase strategy - Management indicated a trend towards lower operating expenses and a dynamic approach to share repurchases based on capital allocation opportunities [49][50] Question: Vertex dispute resolution timing - Management provided a conservative estimate for the resolution of the Vertex dispute, indicating it could extend into 2026 but may resolve sooner [81][83] Question: Impact of competition and large-scale deals - Management emphasized the company's unique position and ability to compete for large transactions, highlighting the increasing frequency of multibillion-dollar deals in the industry [88][90]

Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology and is focused 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, following positive results from the SEQUOIA-HCM Phase 3 clinical trial [3] - Cytokinetics is also developing omecamtiv mecarbil for heart failure with severely reduced ejection fraction (HFrEF), CK-586 for heart failure with preserved ejection fraction (HFpEF), and CK-089 for specific muscular dystrophies and impaired skeletal muscle function [3] Upcoming Events - Cytokinetics is scheduled to report its second quarter results on August 7, 2025, at 4:00 PM Eastern Time [1] - Following the results announcement, a conference call will be held at 4:30 PM Eastern Time to discuss financial results and provide business updates [1][2] - The conference call will be available via webcast and an archived replay will be accessible for six months [2]

Core Insights - Cytokinetics is set to present five key studies related to aficamten at the European Society of Cardiology Congress 2025, highlighting its potential in treating obstructive hypertrophic cardiomyopathy (HCM) [1][4] - The MAPLE-HCM trial compares aficamten with metoprolol, focusing on exercise capacity in patients with left ventricular outflow tract (LVOT) obstruction [2][4] - A late-breaking presentation will address the incidence and impact of atrial fibrillation across three clinical trials involving aficamten [1][2] Presentation Details - The MAPLE-HCM presentation will be led by Dr. Pablo Garcia-Pavia on August 30, 2025, at 9:18 AM CEST in Madrid [2] - The late-breaking clinical science presentation on atrial fibrillation will be conducted by Dr. Ahmad Masri on August 31, 2025, at 4:45 PM CEST in Budapest [2] - Another presentation on the long-term efficacy and safety of aficamten will be given by Dr. Sara Saberi on August 31, 2025, at 5:40 PM CEST [2] Additional Research - A poster presentation will analyze the effect of aficamten compared to metoprolol on cardiac structure and function in symptomatic obstructive HCM [3] - An integrated safety analysis of aficamten in patients with obstructive HCM will also be presented [3] Company Overview - Cytokinetics is a biopharmaceutical company specializing in cardiovascular diseases, with over 25 years of experience in muscle biology [4] - The company is preparing for potential regulatory approvals and commercialization of aficamten following positive results from the SEQUOIA-HCM trial [4] - Cytokinetics is also developing other drug candidates targeting heart failure and muscular dystrophy [4]

Group 1: Corporate Giving Program - Cytokinetics has announced its annual Corporate Giving Program, which aims to provide charitable donations to eligible non-profit organizations in the U.S. to support equitable healthcare initiatives, diversity in science education, and essential services for local and at-risk communities [2][3] - The program offers individual charitable donations of up to $20,000 for qualified 501(c)(3) organizations that are not directly involved in healthcare practices [3] - Applications for the program can be submitted online, with a deadline set for August 4, 2025 [3] Group 2: Corporate Values and Impact - The Corporate Giving Program is designed to partner with non-profit organizations to advance shared missions, particularly focusing on health equity in cardiovascular disease [3] - Cytokinetics aims to expand its impact in its second year of formalized corporate giving, building on the foundation established in 2024 [3] Group 3: 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 [4] - 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 [4] - Cytokinetics is also developing other product candidates, including omecamtiv mecarbil for heart failure, CK-586 for heart failure with preserved ejection fraction, and CK-089 for muscular dystrophy [4]

Core Insights - Cytokinetics will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 4, 2025, at 9:20 AM Eastern Time [1] - The event will be accessible via a live webcast on the Cytokinetics website, with a replay available for 90 days post-event [2] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology [3] - 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 [3] - Aficamten is also being evaluated in additional trials for obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) [3] - Cytokinetics is developing omecamtiv mecarbil for heart failure with severely reduced ejection fraction (HFrEF), CK-586 for heart failure with preserved ejection fraction (HFpEF), and CK-089 for specific muscular dystrophies [3]

Core Insights - Cytokinetics is hosting the second annual Contemporary Landscapes in Muscle Biology Research Symposium (CLIMB) on May 30, 2025, in San Francisco, CA, aimed at fostering scientific exchange in muscle biology [2][3] - The symposium will feature expert speakers and poster presentations focusing on innovations in cardiac and skeletal muscle biology, as well as emerging treatment modalities [3][6] - Cytokinetics is advancing a pipeline of potential new medicines for cardiac muscle dysfunction, including aficamten, which is undergoing regulatory approval following positive Phase 3 trial results [5] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology [5] - The company is developing several drug candidates, including aficamten for obstructive hypertrophic cardiomyopathy (HCM) and omecamtiv mecarbil for heart failure with severely reduced ejection fraction (HFrEF) [5] - Other candidates in development include CK-586 for heart failure with preserved ejection fraction (HFpEF) and CK-089 for specific types of muscular dystrophy [5] Event Details - The CLIMB symposium aims to promote collaboration and networking among scientists and researchers in the field of muscle biology [3] - Registration for the event is open until May 23, 2025 [4] - Keynote speakers include prominent figures from various institutions, highlighting the interdisciplinary nature of the symposium [6]

Core Insights - Cytokinetics announced positive topline results from the MAPLE-HCM Phase 3 clinical trial, demonstrating that aficamten outperforms the standard beta blocker metoprolol in improving peak exercise capacity in patients with obstructive hypertrophic cardiomyopathy (HCM) [1][2][3] Group 1: Clinical Trial Results - MAPLE-HCM met its primary endpoint, showing a statistically significant improvement in peak oxygen uptake (pVO2) from baseline to Week 24 for aficamten compared to metoprolol [2][4] - The safety and tolerability profile of aficamten was favorable compared to metoprolol [2] - Full results from the MAPLE-HCM trial will be presented at an upcoming medical conference [2][3] Group 2: Trial Design and Patient Enrollment - MAPLE-HCM was a Phase 3, multi-center, randomized, double-blind active-comparator trial involving 175 patients, comparing aficamten to metoprolol [4][5] - The primary endpoint was the change in pVO2 from baseline to Week 24, with secondary endpoints including changes in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores and left ventricular mass index (LVMI) [4][5] Group 3: Aficamten Overview - Aficamten is an investigational selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with HCM [6][7] - The drug has received Breakthrough Therapy Designation from the FDA and the NMPA in China for the treatment of symptomatic obstructive HCM [8] Group 4: Regulatory Status and Future Trials - Aficamten is currently under regulatory review by the FDA, with a target action date of December 26, 2025, and is also being reviewed by the EMA and NMPA [9] - Additional clinical trials for aficamten include ACACIA-HCM, CEDAR-HCM, and FOREST-HCM, targeting various patient populations with HCM [10] Group 5: Company Background - Cytokinetics is a biopharmaceutical company focused on developing new medicines for cardiac muscle dysfunction, with over 25 years of experience in muscle biology [11] - The company is preparing for potential regulatory approvals and commercialization of aficamten following positive results from previous trials [11]

Core Insights - Cytokinetics is set to present three Late Breaking Science presentations and one ePoster at the Heart Failure 2025 congress in Belgrade, Serbia from May 17 to May 20, 2025 [1] Group 1: Late Breaking Science Presentations - The first presentation will focus on the efficacy and safety of Aficamten in patients with obstructive hypertrophic cardiomyopathy and mild symptoms, presented by Dr. Iacopo Olivotto on May 17, 2025 [2] - The second presentation will discuss the effect of Aficamten treatment on patients with hypertrophic obstructive cardiomyopathy by geographical region, presented by Dr. Caroline Coats on May 18, 2025 [2] - The third presentation will analyze the effect of Omecamtiv Mecarbil on outcomes using the Win Ratio, as part of an exploratory analysis of the GALACTIC-HF trial, presented by Dr. Kieran F. Docherty on May 19, 2025 [2] Group 2: ePoster Presentation - An ePoster will be presented by Dr. Paulos Gebrehiwet on May 17, 2025, discussing the associations between age and sex and cardiovascular outcomes in patients with non-obstructive hypertrophic cardiomyopathy [3] Group 3: 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 [4] - The company is preparing for potential regulatory approvals and commercialization of Aficamten, following positive results from the SEQUOIA-HCM Phase 3 clinical trial [4] - Cytokinetics is also developing Omecamtiv Mecarbil for heart failure with severely reduced ejection fraction, CK-586 for heart failure with preserved ejection fraction, and CK-089 for specific muscular dystrophies and other conditions [4]

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 [4] - 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 [4] - Other products in development include omecamtiv mecarbil for heart failure with severely reduced ejection fraction (HFrEF), CK-586 for heart failure with preserved ejection fraction (HFpEF), and CK-089 for specific muscular dystrophies [4] Annual Meeting Details - Cytokinetics will hold its Annual Meeting of Stockholders on May 14, 2025, at 10:00 AM Pacific Time at its headquarters in South San Francisco [1] - Stockholders of record as of March 24, 2025, are entitled to vote or attend the meeting in person [2] - A live webcast of the meeting and subsequent company update presentation will be available, with an archived replay accessible for twelve months [3]