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Cytokinetics, Incorporated develops and commercializes muscle-directed cardiovascular medicines, led by MYQORZO® (aficamten), a cardiac myosin inhibitor approved in the U.S., Europe and China for adults with symptomatic obstructive hypertrophic cardiomyopathy. Company news regularly covers MYQORZO clinical data, launch activity, regulatory approvals and analyses from HCM studies including SEQUOIA-HCM, MAPLE-HCM, FOREST-HCM and ACACIA-HCM.
Recurring updates also address Cytokinetics’ pipeline in cardiac muscle dysfunction, including omecamtiv mecarbil for heart failure with severely reduced ejection fraction and ulacamten for heart failure with preserved ejection fraction. Financial releases and corporate announcements include product revenue, operating updates, shareholder voting matters, common stock offerings and other capital-structure developments.
Cytokinetics announced the closing of its public offering of 9,803,922 shares of common stock at $51.00 per share. The offering raised approximately $500 million before expenses. The offering was managed by J.P. Morgan, Goldman Sachs & Co. , and Morgan Stanley. The securities were offered under a shelf registration statement filed in November 2022 with the SEC, which is now effective.
Cytokinetics announced the pricing of a public offering of 9,803,922 shares of its common stock at $51.00 per share.
Expected gross proceeds are approximately $500 million before underwriting discounts and other expenses.
The offering is set to close on May 28, 2024, subject to customary conditions.
The company has also given underwriters a 30-day option to buy an additional 1,470,588 shares at the public offering price, less underwriting discounts and commissions.
J.P. Morgan, Goldman Sachs, and Morgan Stanley are acting as joint book-running managers for the offering.
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.