Group 1 - The Rosen Law Firm is reminding purchasers of Cytokinetics, Inc. common stock from December 27, 2023, to May 6, 2025, about the lead plaintiff deadline on November 17, 2025 [1] - Investors who purchased Cytokinetics common stock during the specified period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - A class action lawsuit has already been filed, and interested parties can join by contacting the Rosen Law Firm [3][6] Group 2 - The lawsuit alleges that Cytokinetics made false and misleading statements regarding the timeline for the New Drug Application (NDA) submission and approval process for aficamten, specifically regarding expected FDA approval in the second half of 2025 [5] - The company failed to disclose material risks related to the submission of a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [5]

Core Points - Cytokinetics, Incorporated is facing a securities class action lawsuit for failing to disclose material information during the class period from December 27, 2023, to May 6, 2025 [1][3] - Investors have until November 17, 2025, to file lead plaintiff applications related to this lawsuit [1] - The lawsuit is currently pending in the United States District Court for the Northern District of California [1] Company Actions - On March 10, 2025, Cytokinetics announced that the FDA would not hold an advisory committee meeting to review its New Drug Application (NDA) for the aficamten product [4] - On May 6, 2025, the company revealed it had multiple pre-NDA meetings with the FDA but chose to submit the NDA without a Risk Evaluation and Mitigation Strategy [4] - Following these announcements, Cytokinetics' share price fell to $33.04 per share on May 7, 2025 [5] Legal Information - The case is identified as Seidman v. Cytokinetics, Incorporated, et al., No. 25-cv-07923 [5] - Kahn Swick & Foti, LLC is available to discuss legal options for affected investors [2]

Core Viewpoint - Cytokinetics, Inc. is facing a class action lawsuit due to alleged misleading statements regarding the New Drug Application (NDA) for aficamten, which may have caused financial losses for investors [1][3]. Group 1: Class Action Details - The class action is on behalf of investors who purchased securities between December 27, 2023, and May 6, 2025, with a deadline for filing a lead plaintiff motion set for November 17, 2025 [1]. - Investors are encouraged to contact the Portnoy Law Firm for legal rights discussions and case evaluations [2]. Group 2: Allegations Against Cytokinetics - The complaint alleges that during the class period, Cytokinetics made materially false and misleading statements about the NDA submission and approval timeline for aficamten [3]. - Specifically, the company indicated an expectation for FDA approval in the second half of 2025, based on a September 26, 2025 PDUFA date, while failing to disclose risks related to the submission of a Risk Evaluation and Mitigation Strategy [3].

Accessibility StatementSkip Navigation 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- 9330Â (Ext. 1310). [You may also click here for additional information] NEW YORK, Oct. 2, 20 ...

Core Insights - Cytokinetics, Inc. (CYTK) has experienced significant volatility in 2025, with a delay in FDA approval for aficamten being a major setback, but recent positive data has boosted investor confidence [1][8]. Group 1: Aficamten's Clinical Data - Aficamten, a selective cardiac myosin inhibitor, demonstrated superiority over the standard beta-blocker metoprolol across all clinically relevant efficacy endpoints in the MAPLE-HCM study [2][3]. - The drug showed significant improvements in symptoms, functional class, and left ventricular outflow tract (LVOT) gradients compared to metoprolol, indicating a substantial reduction in patient symptom burden [3][4]. - Additional data revealed that aficamten improved cardiac structure and function, with an annual incidence rate of atrial fibrillation at 1.5%, consistent with its safety profile [5][10]. Group 2: FDA Approval Process - The FDA extended the target action date for aficamten's new drug application (NDA) to December 26, 2025, due to a request for a Risk Evaluation and Mitigation Strategy (REMS) submission [8][9]. - This extension was classified as a major amendment, but no additional clinical data or studies were requested by the FDA [9][10]. - The delay is particularly impactful as CYTK currently lacks any approved products in its portfolio, and aficamten will face competition from Bristol Myers Squibb's Camzyos (mavacamten) upon approval [11]. Group 3: Collaboration and Financial Aspects - Cytokinetics entered a collaboration and license agreement with Bayer for the exclusive development and commercialization of aficamten in Japan, which includes an upfront payment of €50 million and potential milestone payments totaling €490 million [6][7]. Group 4: Other Pipeline Candidates - Other candidates in Cytokinetics' pipeline include omecamtiv mecarbil, currently in a phase III trial for heart failure, with enrollment expected to close in late 2026 [13]. - The company has also initiated a phase II trial for ulacamten in patients with heart failure with preserved ejection fraction, with completion of initial cohort enrollment expected in the second half of 2025 [14].

Core Viewpoint - Rosen Law Firm is reminding purchasers of Cytokinetics, Inc. common stock of the upcoming lead plaintiff deadline for a class action lawsuit related to misleading statements about the company's New Drug Application process for aficamten [1][5]. Group 1: Class Action Details - The class period for the lawsuit is from December 27, 2023, to May 6, 2025, and the lead plaintiff deadline is November 17, 2025 [1]. - Investors who purchased Cytokinetics common stock during the class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties can join by contacting the Rosen Law Firm [3][6]. Group 2: Legal Representation - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4]. - The firm has achieved significant settlements in the past, including the largest securities class action settlement against a Chinese company at the time and has consistently ranked highly in securities class action settlements [4]. Group 3: Case Specifics - The lawsuit alleges that Cytokinetics made false and misleading statements regarding the timeline for the NDA submission and approval process for aficamten, specifically regarding expected FDA approval in the second half of 2025 [5]. - The company failed to disclose material risks related to the submission of a Risk Evaluation and Mitigation Strategy, which could delay the regulatory process, leading to investor damages when the true details were revealed [5].

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]