Cytokinetics Conference Call Summary Company Overview - **Company**: Cytokinetics (NasdaqGS:CYTK) - **Focus**: Translating muscle biology into new pharmacology, particularly in specialty cardiology - **Pipeline**: Led by myosin modulators, with aficamten as the cornerstone, pending regulatory review for obstructive hypertrophic cardiomyopathy (OHCM) [1][2] Key Points Regulatory and Commercialization Plans - **PDUFA Date**: Aficamten has a PDUFA date set for December 26, 2025, with potential approvals in China expected in Q4 2025 and EMA approval anticipated early next year [1][2] - **Market Strategy**: Aficamten could be commercialized across three continents for OHCM, with plans for a supplemental NDA for non-obstructive hypertrophic cardiomyopathy (NHCM) by the end of 2026 [2][3] Clinical Data and Efficacy - **Clinical Trials**: The Sequoia study showed significant effects on clinical endpoints in OHCM patients, while the Maple study demonstrated aficamten's superiority over standard care [4][5] - **Market Potential**: The NHCM market is growing rapidly, and if the Acacia study yields positive results, Cytokinetics believes it could dominate this market [5][6] Financial Position - **Capital Structure**: Cytokinetics expects to end the year with over $1 billion, closer to $1.2 billion, providing a strong cash runway to support business ambitions [6] Differentiation and Market Adoption - **Differentiated Profile**: Aficamten is expected to have a differentiated risk mitigation profile, with advantages in dosing flexibility and reduced treatment interruptions compared to existing therapies [8][10] - **Current Prescribing Landscape**: Approximately 10,000 cardiologists treat HCM, with less than 20% currently using cardiac myosin inhibitors (CMIs) [11][12] - **Barriers to Adoption**: Administrative burdens associated with risk management programs (REMS) are seen as a key impediment to wider adoption of CMIs [11][12] Launch Expectations - **Launch Trajectory**: The launch is expected to be gradual, similar to previous products, with potential acceleration if Acacia data is positive [13][15] - **Metrics for Success**: Key metrics will include the number of prescribing physicians, new prescribers, and patients on therapy, with a focus on converting free drug patients to paid prescriptions [19][20] Market Dynamics - **Impact of Maple Study**: The Maple study is anticipated to influence prescribing behaviors and potentially expand the CMI market, with expectations for increased patient adds in 2026 and beyond [31][32] - **Guideline Recommendations**: The Maple data may lead to updated treatment guidelines, potentially elevating aficamten's position in treatment protocols [24][26] Strategic Positioning - **Value Creation**: Cytokinetics is focused on executing its strategy to build shareholder value, with a strong pipeline and competitive positioning in the market [43][44] - **Increased Urgency in Biotech**: There is a noted increase in urgency and competition for valuable assets in the biotech space, which may benefit Cytokinetics in potential partnerships or acquisitions [44][45] Conclusion Cytokinetics is poised for significant developments in the specialty cardiology market with aficamten, supported by strong clinical data and a solid financial position. The company is navigating regulatory pathways and preparing for a strategic launch while addressing barriers to adoption and aiming for a differentiated market presence.

LOS ANGELES, Nov. 17, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Cytokinetics, Incorporated, (“Cytokinetics” or the "Company") (NASDAQ: CYTK) investors of a class action on behalf of investors that bought securities between December 27, 2023 and May 6, 2025, inclusive (the “Class Period”). Cytokinetics investors have until November 17, 2025 to file a lead plaintiff motion. Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 844-767-8529 or email: lesley@portnoylaw.com, to dis ...

Accessibility StatementSkip Navigation WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statemen ...

Core Insights - Cytokinetics, Inc. supports a three-year initiative by the American Heart Association to improve care for hypertrophic cardiomyopathy (HCM), addressing disparities in access, diagnosis, and treatment [1][2][3] - HCM affects approximately one in 500 people in the U.S., with many remaining undiagnosed or untreated until severe symptoms arise, leading to fragmented care systems [2][3] - The initiative aims to identify systemic barriers and enhance the identification, assessment, referral, and treatment processes for HCM patients [2][3] Company Commitment - Cytokinetics emphasizes its dedication to the HCM community, aligning its support with its patient-centric culture and scientific focus [2][3] - The company has been actively involved in HCM research and advocacy, collaborating with various stakeholders to improve disease awareness and care pathways [3][5] Initiative Goals - The initiative will increase participation in a national HCM Registry, broaden certification opportunities for healthcare providers, introduce patient support services, and pilot an HCM detection algorithm to reduce underdiagnosis [6]

Core Viewpoint - Rosen Law Firm is encouraging investors of Cytokinetics, Inc. to secure legal counsel before the November 17, 2025 deadline related to a securities class action lawsuit [1][3]. Group 1: Class Action Details - Investors who purchased Cytokinetics common stock between December 27, 2023, and May 6, 2025, 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 must move the Court to serve as lead plaintiff by November 17, 2025 [3]. Group 2: Legal Representation - Investors are advised to select qualified legal counsel with a proven track record in securities class actions, as many firms may lack the necessary experience and resources [4]. - The Rosen Law Firm has a history of significant settlements, including the largest securities class action settlement against a Chinese company, and has recovered hundreds of millions for investors [4]. Group 3: Case Background - The lawsuit alleges that Cytokinetics made false or 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, leading to investor damages when the true details became public [5].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Cytokinetics, Incorporated due to misleading statements regarding the New Drug Application (NDA) for aficamten, which may have led to significant investor losses [2][5][7]. Group 1: Legal Investigation - The law firm is encouraging investors who suffered losses in Cytokinetics between December 27, 2023, and May 6, 2025, to discuss their legal rights [1][2]. - There is a deadline of November 17, 2025, for investors to seek the role of lead plaintiff in a federal securities class action against Cytokinetics [2]. Group 2: Misleading Statements - The complaint alleges that Cytokinetics made materially false and misleading statements about the NDA submission timeline and approval process for aficamten, expecting FDA approval in the second half of 2025 [5]. - The company failed to disclose risks related to not submitting a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [5][6]. Group 3: Impact on Investors - Following the revelation of the misleading statements, class members purchased Cytokinetics' common stock at inflated prices and subsequently suffered significant losses [7]. - The lead plaintiff in the class action will be the investor with the largest financial interest who is typical of class members [8].

Core Points - Rosen Law Firm is reminding purchasers of Cytokinetics, Inc. common stock about the lead plaintiff deadline for a class action lawsuit related to misleading statements made during the Class Period from December 27, 2023, to May 6, 2025 [1][5] Group 1: Class Action Details - 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 must move the Court to serve as lead plaintiff by November 17, 2025 [3] - The lawsuit alleges that Cytokinetics made false and/or misleading statements regarding the New Drug Application submission and approval process for aficamten, specifically concerning the expected FDA approval timeline [5] Group 2: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting its own achievements, including the largest securities class action settlement against a Chinese company [4] - The firm has been ranked No. 1 for securities class action settlements in 2017 and has consistently ranked in the top 4 since 2013, recovering hundreds of millions of dollars for investors [4]

Core Points - Investors have until November 17, 2025, to file lead plaintiff applications in a securities class action lawsuit against Cytokinetics, Incorporated [1] - The class action pertains to investors who purchased or acquired the company's securities between December 27, 2023, and May 6, 2025, inclusive [1]

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 may have led to significant investor losses [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 FDA approval expectations, claiming approval in the second half of 2025 based on a September 26, 2025, PDUFA date [2]. - The company failed to disclose risks related to not submitting a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [2]. - During an earnings call on May 6, 2025, it was revealed that the company had discussions with the FDA about safety monitoring but chose to submit the NDA without a REMS, misleading investors about the regulatory timeline [2]. Group 2: Next Steps for Investors - Investors who suffered losses in Cytokinetics during the relevant timeframe have until November 17, 2025, to request to be appointed as lead plaintiff [3]. - Participation in the lawsuit does not require serving as a lead plaintiff, and class members may be entitled to compensation without any out-of-pocket costs [3]. Group 3: Firm Background - Levi & Korsinsky has a strong track record, having secured hundreds of millions of dollars for shareholders and being recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Cytokinetics, Incorporated due to misleading statements regarding the New Drug Application (NDA) for aficamten, which may have led to investor losses [1][3][5]. Group 1: Legal Investigation - The law firm is encouraging investors who suffered losses in Cytokinetics between December 27, 2023, and May 6, 2025, to discuss their legal options [1]. - A federal securities class action has been filed against Cytokinetics, with a lead plaintiff deadline set for November 17, 2025 [1][6]. Group 2: Misleading Statements - Defendants allegedly made materially false statements about the expected timeline for the NDA submission and approval process for aficamten, claiming FDA approval was anticipated in the second half of 2025 [3]. - The company failed to disclose significant risks related to the omission of a Risk Evaluation and Mitigation Strategy (REMS), which could delay the regulatory process [3][4]. Group 3: Impact on Investors - Following the revelation of the misleading information, class members who purchased Cytokinetics' common stock at inflated prices experienced substantial financial losses [5]. - The firm is also seeking information from whistleblowers, former employees, and shareholders regarding Cytokinetics' conduct [6].