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ROSEN, A LEADING AND RANKED FIRM, Encourages Cytokinetics, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – CYTK
Globenewswire· 2025-10-04 18:00
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]
Cytokinetics Shareholder Alert: ClaimsFiler Reminds Investors With Losses In Excess Of $100,000 Of Lead Plaintiff Deadline In Class Action Lawsuits Against Cytokinetics, Incorporated - CYTK
Prnewswire· 2025-10-04 02:36
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]
Portnoy Law Firm Announces Class Action on Behalf of Cytokinetics, Inc. Investors
Globenewswire· 2025-10-03 18:13
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].
SHAREHOLDER ACTION REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Cytokinetics
Prnewswire· 2025-10-02 15:56
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 ...
Can CYTK Clinch a Potential FDA Nod for Its Cardiovascular Drug?
ZACKS· 2025-10-02 14:11
Key Takeaways Aficamten outperformed metoprolol on all key endpoints in the MAPLE-HCM phase III trial.Additional data showed aficamten improved heart structure, function, and reduced atrial fibrillation.FDA extended aficamten's target action date to Dec. 26, 2025, after requesting a REMS submissionIt has been a roller coaster ride for Cytokinetics, Inc. (CYTK) so far in 2025.While the delay in FDA approval of its lead candidate aficamten for the treatment of patients with obstructive hypertrophic cardiomyop ...
NATIONALLY RANKED ROSEN LAW FIRM Encourages Cytokinetics, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – CYTK
Globenewswire· 2025-10-01 21:10
NEW YORK, Oct. 01, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of common stock of Cytokinetics, Inc. (NASDAQ: CYTK) between December 27, 2023 and May 6, 2025, both dates inclusive (the “Class Period”), of the important November 17, 2025 lead plaintiff deadline. SO WHAT: If you purchased Cytokinetics common stock during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arra ...
Levi & Korsinsky Reminds Cytokinetics Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of November 17, 2025 – CYTK
Globenewswire· 2025-10-01 20:07
NEW YORK, Oct. 01, 2025 (GLOBE NEWSWIRE) -- 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. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/cytokinet ...
Cytokinetics, Incorporated (CYTK) Shareholders Who Lost Money Have Opportunity to Lead Securities Fraud Lawsuit
Prnewswire· 2025-10-01 16:00
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 ...
Class Action Filed Against Cytokinetics, Incorporated (CYTK) - November 17, 2025 Deadline to Join - Contact Levi & Korsinsky
Prnewswire· 2025-10-01 12:45
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. ...
Cytokinetics (NasdaqGS:CYTK) Conference Transcript
2025-09-30 15:02
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]