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Cytokinetics Inc. (symbol: CYTK) is a leading biopharmaceutical company focused on the discovery, development, and commercialization of pioneering muscle activators. With a primary goal of addressing debilitating diseases where muscle performance is compromised, Cytokinetics is at the forefront of muscle biology research.
Specializing in muscle function and contractility, Cytokinetics has developed small molecule drug candidates aimed at enhancing muscle performance. The company’s innovative treatments target diseases such as amyotrophic lateral sclerosis (ALS), heart failure, spinal muscular atrophy (SMA), and chronic obstructive pulmonary diseases (COPD).
Some of the key investigational medicines in the pipeline include:
- CK-4021586 (CK-586): A cardiac myosin inhibitor showing promise in the treatment of cardiac diseases.
- Aficamten: Designed to improve heart muscle function in chronic heart failure patients.
- Omecamtiv Mecarbil: Another advanced therapy aimed at boosting heart muscle performance.
With a strong emphasis on improving the quality of life for patients with severe cardiovascular and neuromuscular diseases, Cytokinetics is committed to groundbreaking research and development. The company's strategic partnerships and collaborations support its mission to bring effective treatments to market, providing hope to patients worldwide.
Recently, Cytokinetics has been actively engaged in investor events and webcasts, sharing forward-looking statements and updates about its latest achievements and ongoing projects. The company's commitment to transparency and investor relations has established it as a reliable entity in the biopharmaceutical industry.
For more detailed updates and news, visit here, here, here, and here.
For investor inquiries, please contact Diane Weiser, Senior Vice President of Corporate Affairs, at (415) 290-7757.
Cytokinetics announced a proposed public offering of approximately $500 million of common stock, subject to market conditions.
The company plans to grant underwriters a 30-day option to purchase up to an additional 15% of the shares sold in the offering.
J.P. Morgan, Goldman Sachs & Co. , and Morgan Stanley will act as joint book-running managers.
The securities will be offered under a shelf registration statement filed with the SEC on November 18, 2022, which is effective.
A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and made available on their website.
This announcement does not constitute an offer to sell or a solicitation of an offer to buy the securities.
Cytokinetics and Royalty Pharma have announced an expanded funding collaboration worth up to $575 million, aimed at supporting the commercial launch of aficamten and advancing Cytokinetics' cardiovascular pipeline.
This partnership provides Cytokinetics with $250 million upon closing, with an additional $175 million potentially available within 12 months post-approval of aficamten in obstructive hypertrophic cardiomyopathy (oHCM). The deal includes funding for Phase 3 trials of omecamtiv mecarbil and Phase 2 trials of CK-586, as well as restructuring royalties on aficamten sales.
Royalty Pharma will also purchase $50 million in Cytokinetics' equity. This strategic collaboration aims to support Cytokinetics' financial stability and growth, while advancing its specialty cardiology projects.
Cytokinetics announced the hosting of the Contemporary Landscapes in Muscle Biology (CLIMB) Research Symposium on May 17, 2024, at the Mission Bay Conference Center in San Francisco. This one-day event will bring together top scientists, researchers, and emerging professionals in the field of muscle biology to share innovative research, foster collaboration, and promote interdisciplinary dialogue. The symposium will feature expert speakers such as Eric Adler, M.D., Rachelle H. Crosbie, Ph.D., and Deepak Srivastava, M.D., among others. Cytokinetics aims to advance the understanding and treatment of muscle-related diseases through this initiative, emphasizing its commitment to pioneering therapeutic applications in muscle biology.
Cytokinetics announced five key presentations on aficamten at the European Society of Cardiology Congress 2024, scheduled from August 30 to September 2 in London. These presentations will cover various aspects of obstructive hypertrophic cardiomyopathy (HCM), including the drug's impact on cardiac structure and function, safety analysis, and patient-reported health status. Noteworthy presentations include insights from the SEQUOIA-HCM CMR substudy by Dr. Ahmad Masri, and clinical applications of biomarkers by Dr. Caroline Coats. This series of presentations aims to highlight aficamten's potential in advancing treatments for HCM.
Cytokinetics announced primary results from the SEQUOIA-HCM Phase 3 clinical trial of aficamten in patients with obstructive HCM. The study showed statistically significant and clinically meaningful improvements in exercise capacity, symptoms, and cardiac function. Results were consistent across all subgroups, with rapid and sustained improvements observed. Aficamten appeared safe and well-tolerated, with no treatment interruptions due to low LVEF. The company plans to submit regulatory filings for approval in the U.S. and Europe later this year.
Cytokinetics announced additional results from the SEQUOIA-HCM Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). The results highlighted dosing, safety, efficacy, and impact on quality of life, presented at the European Society of Cardiology Heart Failure 2024 Congress. The dosing and safety data supported dose down-titration for patients with low left ventricular ejection fraction, potentially enabling individualized dosing and tailored risk mitigation. Aficamten demonstrated predictable dosing with no dose interruptions due to LVEF <50%, showing no major adverse cardiovascular events associated with treatment. The drug resulted in a modest reduction in LVEF, leading to significant reductions in left ventricular outflow tract gradient. The patients achieved therapeutic drug concentrations with minimal LVEF <50%, and the dosing algorithm allowed for same-day adjustments based on LVEF measurements. Additionally, aficamten showed improvements in exercise performance metrics, correlating with cardiac structure and function improvements.
Cytokinetics, Incorporated (Nasdaq: CYTK) reported a net loss of $135.6 million, or $1.33 per share, for the first quarter of 2024 compared to $131.3 million for the same period in 2023. The company has $634.3 million in cash, cash equivalents, and investments as of March 31, 2024. Cytokinetics advanced its muscle-biology portfolio with aficamten, opened enrollment to a pediatric clinical trial for obstructive HCM, and announced topline data from the Phase 1 study of CK-586. The company is preparing for regulatory submissions, engaging in commercial readiness activities, and progressing towards a Phase 2 clinical trial for CK-586. Financially, revenues for Q1 2024 were $0.8 million, a decrease from $4.6 million in Q1 2023, while research and development expenses increased to $81.6 million.
Cytokinetics announced topline data from the Phase 1 clinical study of CK-4021586 (CK-586), showing positive results in safety, tolerability, and pharmacokinetics. The data support the advancement to a Phase 2 clinical trial in patients with heart failure with preserved ejection fraction (HFpEF) starting in Q4 2024. CK-586, a cardiac myosin inhibitor, aims to treat a subgroup of HFpEF patients by addressing underlying hypercontractility. The study met its primary and secondary objectives, with no serious adverse events observed.
Cytokinetics has announced the start of CEDAR-HCM, a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy. The trial aims to evaluate the safety and efficacy of aficamten, a cardiac myosin inhibitor, for the potential treatment of HCM in adolescents and children. The primary endpoint is the change in Valsalva left ventricular outflow tract gradient (LVOT-G) from baseline to Week 12, with secondary endpoints including resting LVOT-G, NYHA Functional Class, pharmacokinetics, and cardiac biomarkers. The trial is expected to enroll two cohorts, with initial enrollment of adolescent patients aged 12 to 17.
Cytokinetics, Incorporated (Nasdaq: CYTK) will hold its Annual Meeting of Stockholders on May 15, 2024, at 10:00 AM Pacific Time, at its headquarters in South San Francisco, CA. Stockholders of record as of March 26, 2024, can attend, vote, and submit questions to management. The CEO will present an overview of the company's performance. Voting can be done in person or via proxy card by May 14, 2024. Interested parties can access the live webcast and a replay on Cytokinetics' website.