Key Takeaways BMY will halt the phase III Librexia ACS trial after milvexian missed efficacy expectations.IDMC advised continuing Librexia AF and Librexia STROKE, with data expected in 2026.The setback hits BMY's cardiovascular ambitions, which include Camzyos and EliquisBristol Myers Squibb (BMY) recently announced that it will discontinue the late-stage Librexia study on cardiovascular candidate milvexian, an investigational oral, highly selective factor XIa (FXIa) inhibitor.BMY and partner Johnson & John ...

While Cytokinetics ( CYTK ) investors go through the ups and downs surrounding the aficamten PDUFA event , let's not forget that aficamten is only a small part of the company - the forward flank, if you will. Behind itDubai-based investor focused on building a resilient, income-generating portfolio with a long-term growth mindset. My approach is primarily long-only, blending dividend-paying equities, REITs, and other income strategies with selective growth opportunities. I believe in disciplined, fundamenta ...

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 by the company 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 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]. Group 2: Legal Representation - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions, highlighting its own achievements in recovering significant amounts for investors [4]. - The firm has been recognized for its performance in securities class action settlements, including a record settlement against a Chinese company and being ranked No. 1 for the number of settlements in 2017 [4].

Core Insights - Cytokinetics is under investigation for potentially misleading investors regarding the regulatory timeline for their drug aficamten, particularly concerning the absence of a Risk Evaluation and Mitigation Strategy (REMS) in their New Drug Application (NDA) [1][2] Company Developments - During a May 6, 2025 earnings call, Cytokinetics disclosed multiple pre-NDA meetings with the FDA but submitted the NDA without a REMS, which misled investors and inflated stock prices [2] - On November 11, 2025, Kaye Edward M. MD, a director at Cytokinetics, sold 5,175 shares at $65.08 each, retaining 9,977 shares [3] - The stock price has fluctuated between $65.33 and $67.98, with a current price of $67.06, reflecting a slight increase of 0.93% or $0.62 [3][4] Market Performance - Cytokinetics has a market capitalization of approximately $7.98 billion, with a trading volume of 813,094 shares [4] - The stock's lowest price in the past year was $29.31, indicating significant volatility [4]

New York, New York--(Newsfile Corp. - November 17, 2025) - If you suffered a loss on your Cytokinetics, Incorporated (NASDAQ: CYTK) investment and want to learn about a potential recovery under the federal securities laws, follow the link below for more information:https://zlk.com/pslra-1/cytokinetics-incorporated-lawsuit-submission-form-2?prid=177791&wire=5&utm_campaign=7or contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or call (212) 363-7500 to speak to our team of experienced sharehol ...

CYTK DEADLINE: ROSEN, GLOBAL INVESTOR RIGHTS COUNSEL, Encourages Cytokinetics, Inc. Investors to Secure Counsel Before Important November 17 Deadline in Securities Class Action - CYTKNovember 17, 2025 1:44 PM EST | Source: The Rosen Law Firm PANew York, New York--(Newsfile Corp. - November 17, 2025) - 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 (th ...

Share 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 purchased or acquired securities 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--(BUSINESS WIRE)--Faruqi & Fa ...

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 ...

Core Insights - Bristol Myers (BMY) has decided to discontinue the late-stage Librexia study for milvexian, an investigational oral factor XIa inhibitor, due to an interim analysis indicating it is unlikely to meet its primary efficacy endpoint [1][2][3] - Following the announcement, BMY's stock fell by 4%, and year-to-date, shares have decreased by 17.5%, contrasting with the industry growth of 14.9% [1] Group 1: Study Discontinuation - The Librexia ACS study was halted after the Independent Data Monitoring Committee (IDMC) found it unlikely to achieve its primary efficacy goal, which is the time to the first occurrence of stroke and non-CNS systemic embolism [3][6] - Despite the discontinuation, the IDMC did not identify any new safety concerns related to milvexian [3][6] Group 2: Other Clinical Trials - BMY and JNJ will continue with two other late-stage studies: Librexia AF for atrial fibrillation and Librexia STROKE for secondary stroke prevention, with top-line data expected in 2026 [4][6] - The IDMC recommended the continuation of these trials, noting they differ from Librexia ACS in patient groups, endpoints, and background therapy [6][7] Group 3: Portfolio Diversification - The discontinuation of the Librexia ACS study is viewed as a setback, but successful development of milvexian for AF and SSP could enhance BMY's cardiovascular portfolio, which includes Camzyos, a cardiac myosin inhibitor [8][9] - BMY is actively seeking to diversify its pipeline, especially as its legacy portfolio faces challenges from generic competition on drugs like Revlimid and Pomalyst [10] Group 4: Recent Acquisitions - BMY announced the acquisition of Orbital Therapeutics for $1.5 billion, which will add OTX-201, a preclinical RNA immunotherapy candidate, to its pipeline [10][11] - This acquisition aims to strengthen BMY's position in the market and expand its therapeutic offerings [11][12]