Core Viewpoint - A class action securities lawsuit has been filed against Cytokinetics, alleging securities fraud related to misleading statements about the New Drug Application (NDA) for aficamten, which could have significant implications for investors [1][2]. Group 1: Lawsuit Details - The lawsuit seeks to recover losses for Cytokinetics investors affected by alleged securities fraud between December 27, 2023, and May 6, 2025 [1]. - Defendants allegedly made materially false statements regarding the NDA submission timeline and failed to disclose risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS) [2]. - The company had multiple pre-NDA meetings with the FDA but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [2]. Group 2: Investor Information - Investors who suffered losses during the relevant timeframe have until November 17, 2025, to request to be appointed as lead plaintiff, although participation does not require this [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Legal Firm Background - Levi & Korsinsky has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the U.S. [4].

Accessibility StatementSkip Navigation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+Newsrooms &Influencers 9k+Digital MediaOutlets 270k+JournalistsOpted In GET STARTED Also from this source LOS ANGELES, Oct. 1, 2025 /PRNewswire/ -- The Law Offices of Frank R. Cruz announces that investors with losses related to Cytokinetics, Incorporated ("Cytokinetics" or the "Company") (NASDAQ: CYTK) have opportunity to lead the securities fraud class action lawsuit. IF YOU ARE AN INVESTOR WHO SUFFERED A ...

NEW YORK , Oct. 1, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Cytokinetics, Incorporated ("Cytokinetics" or the "Company") (NASDAQ: CYTK) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Cytokinetics investors who were adversely affected by alleged securities fraud between December 27, 2023 and May 6, 2025. ...

Summary of Cytokinetics Conference Call Company Overview - **Company**: Cytokinetics - **Focus**: Development of muscle-directed medicines, particularly for cardiovascular and neuromuscular diseases [2][3] Key Points Pipeline and Product Development - **Aficamten**: A cardiac myosin inhibitor pending FDA review, targeting obstructive hypertrophic cardiomyopathy (OHCM) [3][4] - **Sequoia Study**: Phase 3 pivotal study with promising results, NDA submission with a PDUFA date of December 26, 2023 [4][6] - **Maple Study**: Phase 3 study showing improvements in peak VO2 compared to standard care [6][7] - **Acacia Study**: Focused on non-obstructive HCM, results expected in the first half of 2026 [7][8] - **Other Myosin Modulators**: - **Omecamtiv Mecarbil**: For heart failure with reduced ejection fraction (HFrEF) - **Eulocamten**: For heart failure with preserved ejection fraction (HFpEF) [5] Financial Position - **Cash Position**: Approximately $1 billion in cash and equivalents as of June, with access to an additional $425 million from previous deals [8][9] - **Refinancing**: Completed a $650 million refinancing to strengthen financial position [9] Market Strategy - **Target Market**: Specialty cardiology with high unmet needs, focusing on a concentrated customer segment [5][8] - **Commercialization Plans**: Aiming to build a specialty cardiology franchise over the next three to five years [8] Regulatory Expectations - **FDA Interactions**: Positive discussions regarding Aficamten's risk mitigation profile and potential labeling [10][11] - **Differentiation**: Aficamten expected to have a differentiated profile in terms of dosing and monitoring compared to existing therapies [11][19] Competitive Landscape - **Mavacamten**: First-in-class cardiac myosin inhibitor by Bristol Myers Squibb, currently capturing about 15% of diagnosed and treatment-eligible patients with OHCM [21][22] - **Market Growth**: Anticipation that Aficamten's approval could expand the cardiac myosin inhibitor market significantly [21][22] Clinical Data Insights - **Acacia Study Design**: Built on insights from previous studies, aiming for a positive outcome in non-obstructive populations [25][26] - **Patient Outcomes**: Previous studies showed significant improvements in functional class and NT-proBNP levels, indicating potential for positive results in Acacia [26][27] Conclusion - Cytokinetics is positioned to make significant advancements in the treatment of cardiac conditions with its innovative drug candidates, particularly Aficamten, while maintaining a strong financial foundation and strategic market approach [8][9][22]

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Cytokinetics To Contact Him Directly To Discuss Their Options If you suffered losses in Cytokinetics between December 27, 2023 and May 6, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Faruqi & Faruqi ...

Core Viewpoint - A securities class action lawsuit has been filed against Cytokinetics, alleging that the company made materially false and misleading statements regarding the New Drug Application (NDA) for aficamten, which could impact investors who acquired the company's securities during the specified class period [1][8]. Allegations - The lawsuit claims that Cytokinetics misrepresented the timeline for the NDA submission and approval process for aficamten, stating that FDA approval was expected in the second half of 2025 with a PDUFA date of September 26, 2025 [8]. - The company allegedly failed to disclose significant risks, particularly the non-submission of a required Risk Evaluation and Mitigation Strategy (REMS), which could lead to delays in regulatory approval [8]. Key Dates - Investors must contact the law firm before November 17, 2025, to be considered for the lead plaintiff motion deadline [4]. Law Firm Background - Wolf Haldenstein Adler Freeman & Herz LLP, established in 1888, has extensive experience in securities litigation and aims to protect the rights of investors who have suffered financial harm due to misrepresented statements [5].

NEW YORK, Sept. 29, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Cytokinetics, Incorporated (NASDAQ: CYTK). Shareholders who purchased shares of CYTK during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/cytokinetics-incorporated-loss-submission-form/?id=169623&from=3 CLASS ...

One important metric to look for in a stock is an 80 or higher Relative Strength Rating. Cytokinetics (CYTK) stock cleared that benchmark Monday, with a jump from 78 to 83 Monday. Â Hone Your Stock-Picking Skills By Focusing On These Factors IBD's proprietary RS Rating identifies market leadership by showing how a stock's price movement over the last 52… Related news Ginkgo Bioworks Holdings Stock Scores RS Rating Upgrade 9/29/2025Ginkgo Bioworks Holdings sees its Relative Strength Rating move into the elit ...

Accessibility StatementSkip Navigation NEW YORK, Sept. 29, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Cytokinetics, Incorporated (NASDAQ: CYTK). Shareholders who purchased shares of CYTK during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/cytokinetics-incorporated-loss-su ...

Core Insights - Aficamten shows significant improvements in exercise capacity and recovery compared to metoprolol in patients with obstructive hypertrophic cardiomyopathy (oHCM) and demonstrates long-term efficacy and tolerability in non-obstructive hypertrophic cardiomyopathy (nHCM) patients [1][2][6] Group 1: MAPLE-HCM Study Findings - Aficamten demonstrated a statistically significant improvement in peak oxygen uptake (pVO2) with a treatment difference of +2.3 mL/kg/min (p<0.001) compared to metoprolol [3] - Additional analyses revealed improvements in submaximal exercise performance, including anaerobic threshold (+76 mL, p<0.001) and aerobic efficiency (+0.8 mL/min/watt, p=0.004) [4][5] - Aficamten also improved post-exercise recovery metrics, with a faster VO2 recovery rate compared to metoprolol [3] Group 2: FOREST-HCM Study Findings - In the FOREST-HCM study, 79% of patients with nHCM improved by at least one NYHA Functional Class after 96 weeks of treatment, with 74% becoming asymptomatic [7] - Aficamten led to a mean increase of 11.2 points in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) [7] - Cardiac biomarkers such as NT-proBNP and high-sensitivity cardiac troponin I showed significant declines by Week 12 and remained low through Week 96 [7] Group 3: Aficamten Overview - Aficamten is a selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with hypertrophic cardiomyopathy (HCM) [9] - The drug is currently under evaluation in multiple clinical trials, including ACACIA-HCM for nHCM and CEDAR-HCM for pediatric patients with oHCM [11] - Aficamten has received Breakthrough Therapy Designation from the FDA for symptomatic HCM and is undergoing regulatory review in the U.S., Europe, and China [13]