FDA Grants Approval for Cytokinetics' MYQORZO to Treat Obstructive Hypertrophic Cardiomyopathy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 20 2025
0mins
Should l Buy CYTK?
Source: NASDAQ.COM
FDA Approval: Cytokinetics, Inc. received FDA approval for MYQORZO (aficamten) tablets in various strengths to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), aimed at improving functional capacity and symptoms.
Mechanism and Risks: MYQORZO works as an allosteric inhibitor of cardiac myosin, reducing cardiac contractility and LVOT obstruction, but carries a Boxed WARNING for potential heart failure and requires monitoring of left ventricular ejection fraction (LVEF).
REMS Program: Due to the associated risks, MYQORZO will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), specifically the MYQORZO REMS Program.
Market Performance: Following the announcement, CYTK's stock closed at $62.72, with a slight gain during regular trading hours, but dipped to $62.05 in after-hours trading.
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Analyst Views on CYTK
Wall Street analysts forecast CYTK stock price to rise
17 Analyst Rating
15 Buy
2 Hold
0 Sell
Strong Buy
Current: 65.040
Low
61.00
Averages
89.33
High
136.00
Current: 65.040
Low
61.00
Averages
89.33
High
136.00
About CYTK
Cytokinetics, Incorporated is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. The Company is engaged in the commercialization of aficamten, a cardiac myosin inhibitor, and is being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive hypertrophic cardiomyopathy. The Company is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF); CK-586, a cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Cytokinetics Awards Grants to Patient Advocacy Organizations
- Grant Program Overview: Cytokinetics announced the recipients of its 2026 Communications Grant Program, aimed at supporting patient advocacy organizations for hypertrophic cardiomyopathy (HCM), reflecting the company's commitment to patient-centered communication.
- Camp Taylor Initiative: Camp Taylor will utilize the grant to launch 'Living with HCM: Youth Voices from Camp Taylor,' a digital communications project featuring a five-part video series and toolkit designed to raise awareness about HCM and assist healthcare providers in connecting with newly diagnosed families.
- SADS Foundation Campaign: The Canadian SADS Foundation will develop 'Think. Know. Act.: Cardiomyopathy Awareness in Canada,' a six-month digital campaign funded by the grant, aimed at increasing awareness of HCM symptoms, diagnosis, and management while amplifying patient voices and fostering community engagement.
- Grant Program History: The Cytokinetics Communications Grant Program has been running for eight years, providing resources to patient advocacy organizations to enhance their outreach and community engagement, thereby increasing disease awareness and supporting patients and their families.
See More
Cytokinetics Board Faces Claims of Breach of Fiduciary Duty as Stock Plummets
- FDA Review Extension: On May 1, 2025, Cytokinetics disclosed that the FDA extended the review period for its cardiac myosin inhibitor aficamten by three months due to additional time needed for the Risk Evaluation and Mitigation Strategy (REMS), causing a 12.9% drop in stock price to $37.35 per share on May 2, severely impacting investor confidence.
- NDA Submission Lacks REMS: The company admitted to multiple pre-NDA meetings with the FDA but chose to submit the NDA without an accompanying REMS, relying on labeling and voluntary education materials, which raised concerns about its safety monitoring capabilities and led to a further 2.7% decline in stock price to $33.04 per share on May 7.
- Investor Losses Intensify: The ongoing stock price decline has resulted in significant losses for Cytokinetics investors, particularly as the company failed to effectively manage communications and risk assessments with the FDA, potentially leading to future legal actions and a crisis of trust.
- Legal Investigation Initiated: The Law Offices of Frank R. Cruz are investigating whether Cytokinetics' board breached its fiduciary duties to shareholders, and if substantiated, this could have profound implications for the company's governance structure and future shareholder rights.
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Cytokinetics (CYTK) and FuboTV (FUBO) Options Volume Surge
- Cytokinetics Options Activity: Cytokinetics Inc (CYTK) has seen an options volume of 11,482 contracts today, representing approximately 1.1 million underlying shares, which is 51.5% of its average daily trading volume over the past month, indicating heightened market interest in its future performance.
- High Call Option Volume: Within CYTK, the $70 strike call option expiring on May 15, 2026, has traded 5,012 contracts, representing about 501,200 shares, suggesting increased investor expectations for the stock's upward movement.
- FuboTV Options Activity: FuboTV Inc (FUBO) has recorded an options volume of 51,955 contracts today, equating to approximately 5.2 million underlying shares, which constitutes 50.5% of its average daily trading volume over the past month, reflecting strong market interest in its stock.
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Cytokinetics Faces Shareholder Investigation Over Alleged Misleading Statements
- Shareholder Investigation Initiated: Grabar Law Office is investigating whether Cytokinetics' executives breached their fiduciary duties, concerning shareholders who purchased shares before December 27, 2023, which could expose the company to legal and financial risks.
- FDA Review Delay: Cytokinetics disclosed on May 1, 2025, that the FDA postponed the review date for its New Drug Application from September 26, 2025, to December 26, 2025, indicating the company failed to provide necessary risk evaluation strategies in a timely manner, potentially affecting its market credibility.
- Impact of Misleading Statements: Company executives acknowledged that they submitted the NDA without including risk evaluation and mitigation strategies, resulting in significant shareholder losses, which may lead to broader legal liabilities and a decline in market confidence.
- Potential Legal Consequences: Shareholders can seek corporate reforms and fund recovery, indicating that the company's governance structure may face significant challenges, impacting future financing and operational capabilities.
See More
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- Surge in M&A Activity: Six of the year's ten largest biopharma deals occurred in Q4, with Johnson & Johnson spending $14.6 billion on Intra Cellular Therapies, signaling a strong commitment from big pharma to expand their pipelines through acquisitions.
- FDA Approvals Boost Innovation: The FDA approved 44 new therapies in 2025, with 26 approvals in the second half, including Cytokinetics' Myqorzo after 27 years, highlighting a supportive regulatory environment for innovation.
- Clinical Trial Successes: Structure Therapeutics saw its stock more than double after its obesity drug trials showed over 15% weight loss in patients, demonstrating the direct impact of clinical success on company valuations.
See More
Cytokinetics Awards Grants to Patient Advocacy Organizations
- Grant Program Overview: Cytokinetics announced the recipients of its 2026 Communications Grant Program, aimed at supporting patient advocacy organizations for hypertrophic cardiomyopathy (HCM), reflecting the company's commitment to patient-centered communication.
- Camp Taylor Initiative: Camp Taylor will utilize the grant to launch 'Living with HCM: Youth Voices from Camp Taylor,' a digital communications project featuring a five-part video series and toolkit designed to raise awareness about HCM and assist healthcare providers in connecting with newly diagnosed families.
- SADS Foundation Campaign: The Canadian SADS Foundation will develop 'Think. Know. Act.: Cardiomyopathy Awareness in Canada,' a six-month digital campaign funded by the grant, aimed at increasing awareness of HCM symptoms, diagnosis, and management while amplifying patient voices and fostering community engagement.
- Grant Program History: The Cytokinetics Communications Grant Program has been running for eight years, providing resources to patient advocacy organizations to enhance their outreach and community engagement, thereby increasing disease awareness and supporting patients and their families.
See More
Cytokinetics Board Faces Claims of Breach of Fiduciary Duty as Stock Plummets
- FDA Review Extension: On May 1, 2025, Cytokinetics disclosed that the FDA extended the review period for its cardiac myosin inhibitor aficamten by three months due to additional time needed for the Risk Evaluation and Mitigation Strategy (REMS), causing a 12.9% drop in stock price to $37.35 per share on May 2, severely impacting investor confidence.
- NDA Submission Lacks REMS: The company admitted to multiple pre-NDA meetings with the FDA but chose to submit the NDA without an accompanying REMS, relying on labeling and voluntary education materials, which raised concerns about its safety monitoring capabilities and led to a further 2.7% decline in stock price to $33.04 per share on May 7.
- Investor Losses Intensify: The ongoing stock price decline has resulted in significant losses for Cytokinetics investors, particularly as the company failed to effectively manage communications and risk assessments with the FDA, potentially leading to future legal actions and a crisis of trust.
- Legal Investigation Initiated: The Law Offices of Frank R. Cruz are investigating whether Cytokinetics' board breached its fiduciary duties to shareholders, and if substantiated, this could have profound implications for the company's governance structure and future shareholder rights.
See More
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Stock Picks Overview: The second installment of the 2026 Barron’s Roundtable features 30 stock picks from five investment experts, highlighting both well-known companies and lesser-known options.
Familiar Names Included: Among the stock picks are recognizable brands such as Home Depot, Starbucks, and Nike, indicating a mix of established and emerging investment opportunities.
Biodegradable Innovation: The article hints at a British company that has recently acquired a manufacturer of biodegradable sneaker midsoles, showcasing a trend towards sustainable products in the footwear industry.
Investment Insights: The Roundtable serves as a platform for sharing diverse investment strategies and insights, appealing to both seasoned investors and those looking to explore new market trends.
See More
Cytokinetics (CYTK) and FuboTV (FUBO) Options Volume Surge
- Cytokinetics Options Activity: Cytokinetics Inc (CYTK) has seen an options volume of 11,482 contracts today, representing approximately 1.1 million underlying shares, which is 51.5% of its average daily trading volume over the past month, indicating heightened market interest in its future performance.
- High Call Option Volume: Within CYTK, the $70 strike call option expiring on May 15, 2026, has traded 5,012 contracts, representing about 501,200 shares, suggesting increased investor expectations for the stock's upward movement.
- FuboTV Options Activity: FuboTV Inc (FUBO) has recorded an options volume of 51,955 contracts today, equating to approximately 5.2 million underlying shares, which constitutes 50.5% of its average daily trading volume over the past month, reflecting strong market interest in its stock.
- High Put Option Volume: For FUBO, the $2.50 strike put option expiring on January 16, 2026, has seen 28,711 contracts traded, representing around 2.9 million shares, indicating investor concerns about potential declines in the stock's future value.
See More
Cytokinetics Faces Shareholder Investigation Over Alleged Misleading Statements
- Shareholder Investigation Initiated: Grabar Law Office is investigating whether Cytokinetics' executives breached their fiduciary duties, concerning shareholders who purchased shares before December 27, 2023, which could expose the company to legal and financial risks.
- FDA Review Delay: Cytokinetics disclosed on May 1, 2025, that the FDA postponed the review date for its New Drug Application from September 26, 2025, to December 26, 2025, indicating the company failed to provide necessary risk evaluation strategies in a timely manner, potentially affecting its market credibility.
- Impact of Misleading Statements: Company executives acknowledged that they submitted the NDA without including risk evaluation and mitigation strategies, resulting in significant shareholder losses, which may lead to broader legal liabilities and a decline in market confidence.
- Potential Legal Consequences: Shareholders can seek corporate reforms and fund recovery, indicating that the company's governance structure may face significant challenges, impacting future financing and operational capabilities.
See More
Biotech Stocks Surge at Year-End 2025, ETFs Gain 35.84%
- Sector Recovery: The iShares Biotechnology ETF surged 29.51% year-to-date by December 2025, while the State Street SPDR S&P Biotech ETF achieved an even higher gain of 35.84%, indicating a significant recovery in investor confidence in the biotech sector.
- Surge in M&A Activity: Six of the year's ten largest biopharma deals occurred in Q4, with Johnson & Johnson spending $14.6 billion on Intra Cellular Therapies, signaling a strong commitment from big pharma to expand their pipelines through acquisitions.
- FDA Approvals Boost Innovation: The FDA approved 44 new therapies in 2025, with 26 approvals in the second half, including Cytokinetics' Myqorzo after 27 years, highlighting a supportive regulatory environment for innovation.
- Clinical Trial Successes: Structure Therapeutics saw its stock more than double after its obesity drug trials showed over 15% weight loss in patients, demonstrating the direct impact of clinical success on company valuations.
See More
