Program to Provide Support of Communications and Outreach for Patient Advocacy Organizations Focused on Cardiovascular Diseases Deadline for Applications is November 3rd, 2025 SOUTH SAN FRANCISCO, Calif., Sept. 24, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced a call for proposals for the eighth annual Cytokinetics Communications Grant Program. The program will award five grants to patient advocacy organizations serving the hypertrophic cardiomyopathy (HCM) and heart failure communities. The grants are intended to support increased communications, awareness building and community engagement. “A persistent funding gap for patient advocacy organizations is in the area of communications. Without adequate resources, patients and caregivers may miss out on important resources and information, while organizations struggle to effectively engage their communities, donors and partners,” said Mary Pomerantz, Cytokinetics’ Senior Director of Patient Advocacy and Engagement. “Through our Communications Grant Program, now in its eighth year, we are proud to support innovative, high-impact initiatives that amplify patient voices, strengthen connections and broaden reach.” The Cytokinetics Communications Grant Program supports patient advocacy organizations in expanding their reach, awareness and community engagement by providing resources for new or crucial communications, marketing or outreach initiatives that would otherwise be challenging to implement. Funding from the Cytokinetics Communications Grant Program may help with programming or personnel, depending on each organization’s needs. The recipients of the 2025 Cytokinetics Communications Grants were the AICARM APS (Italian Association of Cardiomyopathies), HeartBrothers Foundation, HeartCharged Corporation, Hypertrophic Cardiomyopathy Association (HCMA) and Stichting Cardiomyopathie Onderzoek Nederland (Foundation Cardiomyopathy Research the Netherlands). Eligible organizations must have nonprofit organization or registered charity status in the United States, Canada, Europe or United Kingdom and serve the patient communities in HCM or heart failure. Organizations applying for the grant are required to submit a proposal outlining communication activities that the funding would support and the potential impact of the funding. Applications will be evaluated by a committee of representatives from Cytokinetics based on the proposal’s alignment with selection criteria. More details can be found at the application portal listed below. Recipients are responsible for providing an outcomes report to Cytokinetics to measure the impact and results of the funding at the end of the year. Applications may now be submitted at https://www.cybergrants.com/Cytokinetics/communications_grant. The deadline to apply is November 3, 2025, and the grant recipients will be announced in January 2026. For more information on the program, including eligibility guidelines, visit https://cytokinetics.com/responsibility/grants-and-giving/. 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 is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. In addition, Cytokinetics is developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Disclaimer Aficamten, omecamtiv mecarbil, ulacamten and CK-089 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 C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:CytokineticsDiane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
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Cytokinetics Announces Pricing of Upsized $650.0 Million Convertible Senior Notes Offering; Refinances a Portion of 2027 Convertible Notes
SOUTH SAN FRANCISCO, Calif., Sept. 16, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (“Cytokinetics”) (Nasdaq: CYTK) today announced the pricing of its offering of $650.0 million aggregate principal amount of 1.75% convertible senior notes due 2031 in a private placement (the “offering”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). The aggregate principal amount of the offering was increased from the previously announced offering size of $550.0 million. Key elements of the transaction include: Primarily a refinancing transaction of the 3.50% convertible senior notes due 2027 (the “2027 notes”), which extends the maturity of the refinanced debt to 2031Achieved a lower coupon of 1.75% and a higher conversion price of approximately $68.42 compared to the 2027 notesRetiring approximately $399.5 million of the 2027 notesAny remaining proceeds will be used to support the potential commercial launch of aficamten and for general corporate purposes, including potentially to retire the remaining 2027 notes before or at maturity of those notes that are not exchanged and refinanced pursuant to this transaction The issuance and sale of the notes are scheduled to settle on September 19, 2025, subject to customary closing conditions. Cytokinetics also granted the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $100.0 million aggregate principal amount of notes. The notes will be senior, unsecured obligations of Cytokinetics. The notes will accrue interest at an annual rate of 1.75%, payable semi-annually in arrears on April 1 and October 1 of each year, beginning on April 1, 2026. The notes will mature on October 1, 2031, unless earlier converted, redeemed or repurchased by Cytokinetics. Before July 1, 2031, noteholders will have the right to convert their notes only in certain circumstances. From and after July 1, 2031, noteholders may convert all or any portion of their notes at any time at their election until the close of business on the second scheduled trading day immediately before the maturity date. Cytokinetics will settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock, at Cytokinetics’ election. The initial conversion rate is 14.6156 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $68.42 per share of common stock. The initial conversion price represents a premium of approximately 37.5% over the last reported sale price of $49.76 per share of Cytokinetics’ common stock on September 16, 2025. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events. Cytokinetics’ may not redeem the notes at its election at any time before October 6, 2028. The notes will be redeemable, in whole or in part (subject to certain limitations), at Cytokinetics’ option at any time, and from time to time, on a redemption date on or after October 6, 2028 and, in the case of any partial redemption, on or before the 40th scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if (i) the notes are “freely tradable” (as defined in the indenture for the notes) as of the date Cytokinetics sends the related redemption notice and all accrued and unpaid additional interest, if any, has been paid in full as of the first interest payment date occurring on or before the date such notice is sent and (ii) the last reported sale price per share of Cytokinetics’ common stock exceeds 130% of the conversion price for a specified period of time. If a “fundamental change” (as defined in the indenture for the notes) occurs, then, subject to a limited exception, noteholders may require Cytokinetics to repurchase their notes at a cash repurchase price equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. Use of Proceeds: Cytokinetics estimates that the net proceeds from the offering will be approximately $632.0 million (or approximately $729.4 million if the initial purchasers fully exercise their option to purchase additional notes), after deducting the initial purchasers’ discounts and commissions and Cytokinetics’ estimated offering expenses. Cytokinetics intends to use: approximately $402.5 million of the net proceeds from the offering to pay the cash portion of the consideration in the note exchange transactions as described below; andthe remainder of the net proceeds of this offering will be used (a) to support the potential commercial launch of aficamten, (b) to continue and expand the development program for aficamten, (c) to advance its development and research pipeline, and (d) for general corporate purposes, including potentially to retire the remaining 2027 notes before or at maturity of those notes that are not exchanged and refinanced pursuant to this transaction and working capital. Cytokinetics expects to use approximately $402.5 million of the net proceeds from the offering and to issue 2,168,806 shares of its common stock in exchange for approximately $399.5 million aggregate principal amount of the 2027 notes in privately negotiated transactions (each, a “note exchange transaction”) entered into concurrently with the pricing of the offering. The terms of each note exchange transaction will depend on a variety of factors, including the market price of Cytokinetics’ common stock and the trading price of the 2027 notes at the time of such note exchange transactions. No assurance can be given as to how much, if any, of the 2027 notes will be exchanged or the terms on which they will be exchanged. This press release is not an offer to exchange the 2027 notes, and the offering of the notes is not contingent upon the note exchange transactions. In connection with any note exchange transaction, Cytokinetics expects that holders of the 2027 notes who agree to have their 2027 notes exchanged and who have hedged their equity price risk with respect to such 2027 notes (the “hedged holders”) will, concurrently with, or shortly after, the pricing of the notes, unwind all or part of their hedge positions by buying Cytokinetics’ common stock and/or entering into or unwinding various derivative transactions with respect to its common stock. The amount of Cytokinetics’ common stock to be purchased by the hedged holders or the notional number of shares of Cytokinetics’ common stock underlying such derivative transactions may be substantial in relation to the historic average daily trading volume of Cytokinetics’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Cytokinetics’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price for the notes. Cytokinetics cannot predict the magnitude of such market activity or the overall effect it will have on the price of the notes or its common stock. The offer and sale of the notes, any shares of common stock issuable upon conversion of the notes and any shares of common stock issuable in connection with any note exchange transaction have not been, and will not be, registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws. This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any 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 to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. Forward-Looking Statements This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the completion of the offering, the expected amount and intended use of the net proceeds and the timing or amount of any exchanges of the 2027 notes by Cytokinetics and the potential impact of the foregoing or related transactions on the market price of Cytokinetics’ common stock or the price of the notes. Forward-looking statements represent Cytokinetics’ current expectations regarding future events and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those implied by the forward-looking statements. Among those risks and uncertainties are market conditions, the satisfaction of the closing conditions related to the offering and risks relating to Cytokinetics’ business, including in its Annual Report on Form 10-K for the period ended December 31, 2024, filed with the SEC on February 27, 2025 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2025 and June 30, 2025, filed with the SEC on May 6, 2025 and August 7, 2025, respectively, and other filings that Cytokinetics makes from time to time with the SEC. Cytokinetics may not consummate the offering or the note exchange transactions described in this press release and, if the offering is consummated, cannot provide any assurances regarding its ability to effectively apply the net proceeds as described above. The forward-looking statements included in this press release speak only as of the date of this press release, and Cytokinetics does not undertake to update the statements included in this press release for subsequent developments, except as may be required by law. Contact:Cytokinetics, Inc.Diane WeiserSenior Vice President, Corporate Affairs(650) 624-3060
Cytokinetics Announces Primary Results from MAPLE-HCM Presented at the European Society of Cardiology Congress 2025 and Published in The New England Journal Of Medicine
Positive Trial Demonstrates Superiority of Aficamten to Standard-of-Care Beta-Blocker Metoprolol Primary Endpoint Result Consistent Across All Prespecified Subgroups Company to Host Investor Event and Webcast Tuesday September 2, 2025, at 8:00 AM Eastern Time SOUTH SAN FRANCISCO, Calif., Aug. 30, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that primary results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) were presented in a Hot Line Session at the European Society of Cardiology Congress 2025 in Madrid, Spain, and simultaneously published in The New England Journal of Medicine.1 MAPLE-HCM is a Phase 3 randomized, double-blind, active-comparator clinical trial of aficamten compared to metoprolol in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). MAPLE-HCM enrolled 175 patients, randomized on a 1:1 basis to receive aficamten or metoprolol as monotherapy. Compared to SEQUOIA-HCM, the pivotal Phase 3 clinical trial of aficamten, MAPLE-HCM was designed to include patients with less severe oHCM, enrolling patients without obstruction at rest and with higher predicted peak oxygen uptake (pVO2). “This important study has the potential to inform our approach to treating obstructive HCM, as MAPLE-HCM provides the field its first look at a cardiac myosin inhibitor compared directly to a beta-blocker,” said Pablo Garcia-Pavia, M.D., Ph.D., Head of the Inherited Cardiac Diseases and Heart Failure Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro and Full Professor, Centro Nacional de Investigaciones Cardiovasculares in Madrid, Spain. “In showing that aficamten is superior to metoprolol on all clinically relevant efficacy endpoints, these results call into question the reliance on beta-blockers as the initial treatment modality for obstructive HCM that has prevailed for over 60 years.” “These results demonstrate that aficamten meaningfully improves exercise capacity in patients with obstructive HCM while treatment with metoprolol resulted in a meaningful reduction in exercise capacity,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “The clinical difference in the two treatments is reinforced by the effect of aficamten on the secondary endpoints. Compared to first-line standard-of-care metoprolol, treatment with aficamten had a larger effect on measures of symptoms, functional class, and LVOT gradients. Importantly, these effects were achieved in a broader patient population with oHCM than previously studied in SEQUOIA-HCM, inclusive of patients in MAPLE-HCM with less severe disease as measured by objective metrics of disease burden.” Aficamten is an investigational drug candidate currently under regulatory review in the U.S; the Food and Drug Administration (FDA) is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. Results of MAPLE-HCM The primary endpoint in MAPLE-HCM was the mean change from baseline in pVO2 for aficamten compared to metoprolol after 24 weeks of treatment. For aficamten, the mean change in pVO2 from baseline to Week 24 was +1.1 mL/kg/min (95% CI 0.5 to 1.7) and for metoprolol was -1.2 mL/kg/min (95% CI -1.7 to -0.8). The primary endpoint was statistically significant with a least-squares mean (LSM) difference between groups of 2.3 mL/kg/min (95% CI 1.5 to 3.1; p
Cytokinetics Names Jim Daly to Board of Directors
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-stage, global biopharma companies,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We are pleased to welcome him to our Board and look forward to his contributions and oversight as our company advances toward becoming a fully integrated commercial organization.” Most recently, Mr. Daly served as the Chief Commercial Officer at Incyte Corporation where he led the launch of Jakafi® (ruxolitinib) and oversaw development of the company’s global commercial capabilities. Previously, he spent 10 years at Amgen where he held multiple senior leadership positions, including Senior Vice President of North America Commercial Operations, and launched several successful medicines including Neulasta®, Xgeva®, Nplate® and Vectibix®. He began his career at GlaxoSmithKline, serving in escalating positions of seniority over his 16-year tenure with the company. He earned a B.S. in Pharmacy and an M.B.A. from the University at Buffalo, SUNY. Mr. Daly currently serves on the Boards of Madrigal Pharmaceuticals, argenx SE, and Acadia Pharmaceuticals. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. 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 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 and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
Cytokinetics Reports Second Quarter 2025 Financial Results and Provides Business Update
Regulatory Reviews of Aficamten for Obstructive HCM Progressing in U.S., E.U. and China; Late-Cycle Meeting with U.S. FDA Scheduled for September Ahead of December 26, 2025 PDUFA Date Primary Results from MAPLE-HCM to be Presented in a Hot Line Session at the European Society of Cardiology Congress 2025 ~$1.0 Billion in Cash, Cash Equivalents and Investments as of June 30, 2025 SOUTH SAN FRANCISCO, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the second quarter of 2025. “Following solid progress in the first half of the year, we are looking forward to several key corporate milestones. Our primary focus remains on preparations for the potential FDA approval of aficamten in late December and subsequent commercial launch in early 2026,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Additionally, we are pleased to be sharing results from MAPLE-HCM later this month, which we believe will provide important information related to the standard-of-care in obstructive HCM. With our current balance sheet and additional access to capital, we are well-positioned to execute on both the commercialization and potential label expansion opportunities of aficamten while also advancing our later-stage specialty cardiovascular pipeline.” Q2 and Recent Highlights Cardiac Muscle Programs aficamten (cardiac myosin inhibitor) Continued to support the review of the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) by the U.S. Food and Drug Administration (FDA). With the three-month extension of the Prescription Drug User Fee Act (PDUFA) target action date to December 26, 2025, the late cycle meeting is now scheduled to occur in September.Prepared responses to the Day 120 List of Questions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the Marketing Authorization Application (MAA) for aficamten for the treatment of obstructive HCM; submission on track to meet the clock stop timeline agreed with EMA. We expect a potential EMA decision regarding the MAA in 1H 2026.Completed all Good Clinical Practice (GCP) inspections for applications under review.Continued to support the review of the NDA for aficamten for obstructive HCM by the Center for Drug Evaluation (CDE) in China. Advanced the ongoing clinical trials program for aficamten: Announced positive topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM). The primary results will be presented in a Hot Line Session in August at the European Society of Cardiology Congress 2025.Continued conduct of ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), a pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM. We expect to share topline results of the primary cohort (excluding Japan) in 1H 2026. Dosed the first patient in the Japan cohort of ACACIA-HCM. Dosed the first patient in CAMELLIA-HCM, a Phase 3 clinical trial of aficamten in Japanese patients with obstructive HCM. CAMELLIA-HCM is being conducted by Bayer in collaboration with Cytokinetics to support potential marketing authorization in Japan.Continued enrolling patients in CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive HCM. We expect to complete patient enrollment of the adolescent cohort in 2H 2025. Presented new analyses at the European Society of Cardiology Heart Failure 2025 Congress from SEQUOIA-HCM on the effect of aficamten between patients with mild and moderate-to-severe symptoms, and across geographic regions. Expanded U.S. commercial readiness activities for aficamten including sales force recruitment, final stages of implementing patient support programs and finalization of our promotional launch campaign. Continued payer engagement to educate on the clinical data supportive of aficamten and the clinical and economic burden of HCM.Advanced European commercial readiness activities including hiring key leadership positions in our European headquarters and other EU and UK geographies, preparing Health Technology Assessment (HTA) dossiers and ensuring launch readiness for potential approval in Germany in 1H 2025. Published the following manuscripts: “A Plain Language Summary of the SEQUOIA-HCM Study: Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy” in Future Cardiology“Efficacy of Aficamten in Patients with Obstructive Hypertrophic Cardiomyopathy and Mild Symptoms: Results from the SEQUOIA-HCM Trial” in the European Heart Journal“Associations of Sex on Economic Burden in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy: Results from Medical and Pharmacy Claims Data in Frontiers in Cardiovascular Medicine“Aficamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: 48-weeks Results From FOREST-HCM” in the Journal of the American College of Cardiology – Heart Failure“Concomitant Aficamten and Disopyramide in Symptomatic Obstructive Hypertrophic Cardiomyopathy” in the Journal of the American College of Cardiology – Heart Failure“Clinical Evaluation of the Effect of Aficamten on QT/QTc Interval in Healthy Participants” in Clinical and Translational Science omecamtiv mecarbil (cardiac myosin activator) Continued conduct of COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. We expect to continue enrollment through 2025 to enable completion of enrollment in late 2026. ulacamten (CK-4021586, cardiac myosin inhibitor) Received approval from the International Nonproprietary Names (INN) Program of the World Health Organization for ulacamten to be used as the nonproprietary name for CK-4021586.Continued conduct of AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 clinical trial of ulacamten in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥ 60%. We expect to complete patient enrollment of the first two cohorts in 2H 2025. Pre-Clinical Development and Ongoing Research Continued pre-clinical development and research activities directed to additional muscle biology focused programs. Second Quarter 2025 Financial Results Cash, Cash Equivalents and Investments As of June 30, 2025, the company had approximately $1.0 billion in cash, cash equivalents and investments compared to $1.1 billion at March 31, 2025. Cash, cash equivalents and investments declined by $52.6 million during the second quarter of 2025. The Company received $75 million in proceeds from the drawing on Tranche 4 of the Royalty Pharma Multi Tranche Term Loan in the second quarter of 2025. Revenues Total revenues for the second quarter of 2025 were $66.8 million compared to $0.2 million for the same period in 2024. Revenues in the second quarter of 2025 included the recognition of $52.4 million related to the Company’s license and collaboration agreement for aficamten in Japan with Bayer, and $11.7 million for the achievement of clinical milestones in the non-obstructive HCM and obstructive HCM trials in Japan. Research and Development (R&D) Expenses R&D expenses for the second quarter of 2025 were $112.6 million, which included $13.5 million of non-cash stock-based compensation expense, compared to $79.6 million for the same period in 2024, which included $11.5 million of non-cash stock-based compensation expense. The increase was primarily due to advancing our clinical trials, higher personnel-related costs, and medical affairs-related activities. General and Administrative (G&A) Expenses G&A expenses for the second quarter of 2025 were $65.7 million, which included $14.0 million of non-cash stock-based compensation expense, compared to $50.8 million for the same period in 2024, which included $13.1 million of non-cash stock-based compensation expense. The increase was primarily due to investments toward commercial readiness and higher personnel-related costs. Net Income (Loss) Net loss for the second quarter of 2025 was $134.4 million, or $(1.12) per share, basic and diluted, compared to a net loss of $143.3 million, or $(1.31) per share, basic and diluted, for the same period in 2024. 2025 Financial Guidance The company is maintaining its full year 2025 financial guidance: GAAP operating expense*$670 million to $710 millionNon-cash stock-based compensation expense included in GAAP operating expense$120 million to $110 million *GAAP operating expense comprised of R&D and SG&A expenses. Anticipated year-over-year increase in GAAP operating expense includes investments toward commercial readiness for the potential approval and launch of aficamten for patients with obstructive HCM. The financial guidance does not include the effect of GAAP adjustments as may be caused by events that occur subsequent to publication of this guidance, including but not limited to Business Development activities. Conference Call and Webcast Information Members of Cytokinetics’ senior management team will review the company’s second quarter 2025 results on a conference call today at 4:30 PM Eastern Time. 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 Q2 2025 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 to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. 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 claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of any of our clinical trials, or more specifically, our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, our ability to complete enrollment of CEDAR-HCM and AMBER-HFpEF in the second half of 2025, our ability to complete patient enrollment of COMET-HF in 2026, our ability to announce the results of ACACIA-HCM in the first half of 2026, our ability to announce the results of any of our clinical trials by any particular date, the timing of interactions with FDA or any other regulatory authorities in connection to any of our drug candidates and the outcomes of such interactions; statements relating to the potential patient population who could benefit from aficamten, omecamtiv mecarbil, CK-586, CK-089 or any of our other drug candidates; statements relating to our ability to receive additional capital or other funding, including, but not limited to, our ability to meet any of the conditions relating to or to otherwise secure additional loan disbursements under any of our agreements with entities affiliated with Royalty Pharma or additional milestone payments from Sanofi or Bayer in connection with our collaborations for aficamten in China or Japan respectively; statements relating to our operating expenses or cash utilization for the remainder of 2025 or any other period, and statements relating to our cash balance at any particular date or the amount of cash runway such cash balances represent at any particular time. 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 Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may incur unanticipated research and development and other costs; 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, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-A for the quarter ended March 31, 2025. 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 and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757 Cytokinetics, IncorporatedCondensed Consolidated Balance Sheets(in thousands) June 30, 2025 December 31, 2024 (unaudited) ASSETS Current assets: Cash and short term investments $858,135 $1,076,014 Other current assets 28,407 31,926 Total current assets 886,542 1,107,940 Long-term investments 178,201 145,055 Property and equipment, net 70,219 65,815 Operating lease right-of-use assets 76,120 75,158 Other assets 14,553 7,705 Total assets $1,225,635 $1,401,673 LIABILITIES AND STOCKHOLDERS’ DEFICIT Current liabilities: Accounts payable and accrued liabilities $68,543 $75,692 Short-term operating lease liabilities 19,585 18,978 Current portion of long-term debt 14,400 11,520 Derivative liabilities measured at fair value 17,600 11,300 Deferred revenue 1,344 52,370 Other current liabilities 9,592 9,814 Total current liabilities 131,064 179,674 Term loan, net 159,058 93,227 Convertible notes, net 553,987 552,370 Liabilities related to revenue participation right purchase agreements, net 489,503 462,192 Long-term operating lease liabilities 111,028 112,582 Liabilities related to RPI Transactions measured at fair value 147,700 137,000 Other non-current liabilities 2,015 — Total liabilities 1,594,355 1,537,045 Commitments and contingencies Stockholders’ deficit Common stock 119 118 Additional paid-in capital 2,628,829 2,563,876 Accumulated other comprehensive (loss) income (158) 2,398 Accumulated deficit (2,997,510) (2,701,764)Total stockholders’ deficit (368,720) (135,372)Total liabilities and stockholders’ deficit $1,225,635 $1,401,673 Cytokinetics, IncorporatedCondensed Consolidated Statements of Operations(in thousands except per share data)(unaudited) Three Months Ended Six Months Ended June 30, 2025 June 30, 2024 June 30, 2025 June 30, 2024Revenues: Collaboration revenues $2,416 $249 $3,995 $1,084 License and milestone revenues 64,353 — 64,353 — Total revenues 66,769 249 68,348 1,084 Operating expenses: Research and development 112,554 79,597 212,395 161,167 General and administrative 65,721 50,824 123,090 96,324 Total operating expenses 178,275 130,421 335,485 257,491 Operating loss (111,506) (130,172) (267,137) (256,407)Interest expense (11,084) (12,732) (19,952) (19,835)Non-cash interest expense on liabilities related to revenue participation right purchase agreements (13,181) (11,567) (27,259) (21,785)Interest and other income, net 13,001 11,553 26,702 19,466 Change in fair value of derivative liabilities 3,000 (600) 2,600 (600)Change in fair value of liabilities related to RPI Transactions (14,600) 200 (10,700) 200 Net loss $(134,370) $(143,318) $(295,746) $(278,961)Net loss per share — basic and diluted $(1.12) $(1.31) $(2.49) $(2.63)Weighted-average number of shares used in computing net loss per share — basic and diluted 119,457 109,240 118,979 106,013
Cytokinetics Announces Positive Topline Results From MAPLE-HCM
Trial Demonstrates Superiority of Aficamten to Standard of Care Beta Blocker in Improving Peak Exercise Capacity in Patients with Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., May 13, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced positive topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a Phase 3 clinical trial comparing aficamten as monotherapy to the standard of care beta blocker metoprolol as monotherapy in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). MAPLE-HCM met its primary endpoint, demonstrating a statistically significant improvement in peak oxygen uptake (pVO2) from baseline to Week 24 for aficamten compared to metoprolol. The safety and tolerability profile of aficamten was favorable in comparison to metoprolol in MAPLE-HCM. The full results from MAPLE-HCM will be presented at an upcoming medical conference. “These results represent the first evidence that aficamten may be used as monotherapy to deliver clinically meaningful improvements in people living with obstructive hypertrophic cardiomyopathy,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Importantly, the results from MAPLE-HCM provide important context to the benefit of this potential new medicine compared to the current standard of care. We are grateful to the investigators, site personnel and patients who participated in MAPLE-HCM, and look forward to presenting the full results at an upcoming medical meeting.” MAPLE-HCM: Clinical Trial Design 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. 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
Cytokinetics Announces New PDUFA Date for Aficamten in Obstructive Hypertrophic Cardiomyopathy
SOUTH SAN FRANCISCO, Calif., May 01, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26, 2025. The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy (REMS). Following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing. Recently, during the NDA review, the FDA requested that Cytokinetics submit a REMS, based on the inherent characteristics of aficamten, which the company provided. The submission of a REMS has now been determined by FDA to be a Major Amendment to the NDA resulting in a standard three-month extension to the original PDUFA action date. No additional clinical data or studies have been requested of Cytokinetics by FDA. “We remain confident in the distinct benefit-risk and pharmaceutic profile of aficamten and continue to expect a differentiated label and risk mitigation profile upon its potential approval by FDA,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We look forward to continuing our constructive engagement with the FDA regarding the NDA for aficamten.” About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology to advance a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. 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 claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by the target PDUFA date or any other date, if ever, and statements regarding our expectation that aficamten will be approved with a differentiated label and REMS. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including FDA’s on-going review of our NDA for aficamten in obstructive hypertrophic cardiomyopathy. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Annual Report on Form 10-K for the year ended December 31, 2024. 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 and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
Cytokinetics Announces Five Presentations at the American College of Cardiology Annual Scientific Session & Expo
New Analyses Related to Aficamten Expand on its Metabolism Pathways,Treatment Effect Associated with Combination Therapy with Disopyramideand Longer-Term Effect on Cardiac Structure and Function SOUTH SAN FRANCISCO, Calif., March 17, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced five presentations related to aficamten, an investigational cardiac myosin inhibitor, and hypertrophic cardiomyopathy (HCM), at the American College of Cardiology (ACC) Annual Scientific Session & Expo taking place from March 29, 2025–March 31, 2025 in Chicago, IL. “We are pleased to be sharing several new analyses relating to aficamten at the upcoming ACC Scientific Session & Expo,” said Stephen Heitner, M.D., Vice President, Head of Clinical Research. “The presentations describe the drug metabolism of aficamten, the safety of combination therapy with the standard of care medication disopyramide, and the effect of longer-term use of aficamten. Together these analyses add to the strong and growing evidence base supporting the potential for aficamten in patients with obstructive HCM and inform how it may be used in clinical practice.” Evaluation of Cytochrome P450 2C9, 2C19, and 2D6 Inhibition on the Pharmacokinetics of Aficamten in Healthy Participants (1091-139)Poster Presentation, March 29, 2025, 2:00-3:00 PM CT, South Hall. Neha Maharao, Ph.D., Senior Clinical Pharmacologist, Cytokinetics. Data from an open-label, fixed-sequence drug-drug interaction (DDI) study of aficamten in healthy participants will be presented in a poster presentation. A previous study showed that aficamten is metabolized, in part, by the cytochrome P450 (CYP) enzyme 3A41. To further characterize its metabolic pathways, aficamten was evaluated with concomitant administration of three strong inhibitors of one or more of the CYP pathways: fluconazole (inhibitor of 2C9, 2C19, and 3A4), paroxetine (inhibitor of 2D6) and fluoxetine (inhibitor of 2C19 and 2D6). The data show that aficamten was eliminated by multiple CYP pathways, primarily by CYP2C9 (fraction metabolized [fm]=50%), with contributions from CYP3A (fm=26%), CYP2D6 (fm=21%) and CYP2C19 (fm=3%). Safety and Outcomes of Concomitant Aficamten and Disopyramide Use and Withdrawal in Patients with Obstructive Hypertrophic Cardiomyopathy: An Analysis of REDWOOD-HCM Cohort 3, SEQUOIA-HCM, and FOREST-HCM Trials (411-06)Oral Presentation, March 31, 2025, 9:11-9:18 AM CT, S406b. Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University. Data from an analysis of concomitant treatment with aficamten and disopyramide from completed and ongoing clinical trials of aficamten in patients with obstructive HCM will be presented in an oral presentation. The analysis included 50 participants from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM) and FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) who were receiving disopyramide at baseline. Participants were separated into four groups: those on disopyramide who underwent withdrawal of aficamten due to end of treatment in Cohort 3 of REDWOOD-HCM or SEQUOIA-HCM (n=29), patients on disopyramide receiving placebo in SEQUOIA-HCM (n=20), patients on aficamten who underwent disopyramide withdrawal in FOREST-HCM (n=17) and patients on aficamten who maintained treatment with disopyramide in FOREST-HCM (n=27). Combination therapy with aficamten and disopyramide was well-tolerated; the analysis suggests that combination of disopyramide with aficamten did not result in lower left ventricular outflow tract (LVOT) gradients compared to treatment with aficamten alone. The analysis suggests that withdrawal of disopyramide while receiving aficamten did not reduce the efficacy of aficamten and further that withdrawal of aficamten while on disopyramide resulted in the return of LVOT obstruction and symptoms, with an increase in NT-proBNP. There were no safety events reported with either aficamten or disopyramide withdrawal, and no episodes of atrial fibrillation after disopyramide withdrawal were reported. Effect of Aficamten Treatment for Up to 72 Weeks on Cardiac Structure and Function in Patients with Obstructive Hypertrophic Cardiomyopathy: The SEQUOIA-HCM and FOREST-HCM CMR Sub-studies (964-09)Moderated Poster Presentation, March 30, 2025, 12:06-12:13 PM CT, Theater 5. Ahmad Masri, M.D., MS, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University. New data from the cardiac magnetic resonance (CMR) imaging sub-studies of FOREST-HCM and SEQUOIA-HCM will be presented in a moderated poster presentation. At the time of the current analysis, 64 patients had completed a baseline CMR, including 36 patients who had completed a follow-up CMR at 72 weeks, and 28 patients who had completed a follow-up CMR at 48 weeks. Longer-term treatment with aficamten resulted in statistically significant improvements (mean ±SD) in measures of cardiac structure and function including left ventricular mass index (-9.8 g/m2 ±18.1, p
Cytokinetics Announces Start of AMBER-HFpEF, a Phase 2 Clinical Trial of CK-586 in Patients With Symptomatic Heart Failure With Preserved Ejection Fraction
SOUTH SAN FRANCISCO, Calif., Jan. 21, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF) is open to enrollment. AMBER-HFpEF is a Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial of CK-4021586 (CK-586) in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥60%. CK-586 is a cardiac myosin inhibitor in development for the potential treatment of a subgroup of with symptomatic HFpEF patients with hypercontractility and ventricular hypertrophy.
Cytokinetics Presents Additional Data From GALACTIC-HF at the American Heart Association Scientific Sessions 2024
SOUTH SAN FRANCISCO, Calif., Nov. 16, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data from post-hoc analyses of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL.



