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Cytokinetics and Olympic Gold Medalist Sydney McLaughlin-Levrone Team Up to Raise Awareness of the Whole-Person Impact of Hypertrophic Cardiomyopathy (HCM)
Globenewswire· 2026-01-27 13:00
“On Track with HCM” Features Practical Insights for Managing Everyday Life with the Disease, Inspired by the Experience with HCM of McLaughlin-Levrone’s Father, Willie McLaughlin SOUTH SAN FRANCISCO, Calif., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the launch of “On Track with HCM,” demonstrating the company’s long-standing commitment to the HCM community. The campaign features four-time Olympic gold medalist Sydney McLaughlin-Levrone, and her father, three ...
Cytokinetics Announces MYQORZO™ (aficamten) Now Available in the U.S. for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms
Globenewswire· 2026-01-27 12:30
Core Insights - MYQORZO™ (aficamten) has been approved by the U.S. FDA for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), aimed at improving functional capacity and symptoms [1][4][5] - The drug is available in multiple dosages (5 mg, 10 mg, 15 mg, and 20 mg) and is a once-daily oral allosteric and reversible inhibitor of cardiac myosin motor activity, which reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction in patients with oHCM [2][17] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [21] - The launch of MYQORZO marks a significant milestone for Cytokinetics, reflecting its commitment to patients and the culmination of extensive scientific and clinical development efforts [3][21] Product Details - MYQORZO is indicated specifically for adults with symptomatic oHCM, and it works by inhibiting cardiac myosin to alleviate symptoms associated with the condition [5][17] - The drug has been engineered for predictable exposure response, rapid onset of action, and reversibility, making it a novel treatment option for patients [17] Clinical and Safety Information - The approval of MYQORZO was based on positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine [4] - Important safety information includes a boxed warning for the risk of heart failure due to reduced left ventricular ejection fraction (LVEF), necessitating regular echocardiogram assessments during treatment [6][9][10] Distribution and Support Programs - MYQORZO is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program, which includes specific requirements for prescribers, patients, and pharmacies [11][15] - Cytokinetics has established a personalized support program, MYQORZO & You™, to assist patients in navigating their treatment journey and provide education and financial assistance [4][21]
The Law Offices of Frank R. Cruz Announces Investigation of Cytokinetics, Incorporated (CYTK) on Behalf of Investors
Businesswire· 2026-01-22 19:39
LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz is investigating potential claims against the board of directors of Cytokinetics, Incorporated ("Cytokinetics†or the "Company†) (NASDAQ: CYTK) concerning whether the board breached its fiduciary duties to shareholders. If you are a shareholder, click HERE to participate. On May 1, 2025, Cytokinetics disclosed that the FDA has extended the review period for its cardiac myosin inhibitor drug, aficamten, by three months, citing additi. ...
Cytokinetics, Incorporated (CYTK) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
Seeking Alpha· 2026-01-12 20:46
PresentationWelcome, everyone, to the 44th Annual JPMorgan Healthcare Conference. My name is Tessa Romero, and I'm one of the senior biotech analysts here at JPMorgan. Our next presenting company is Cytokinetics. And presenting on behalf of the company, we have President and CEO, Robert Blum. Robert, over to you.Robert I. BlumCEO, President & Director Thank you, Tessa, and thank you to JPMorgan for inviting us again this year. This is a very important year for Cytokinetics, as I'll be elaborating as we are ...
Cytokinetics (NasdaqGS:CYTK) FY Conference Transcript
2026-01-12 18:47
Cytokinetics (NasdaqGS:CYTK) FY Conference January 12, 2026 12:45 PM ET Company ParticipantsFady Malik - Head of R&DNone - Video NarratorAndrew Callos - Chief Commercial OfficerRobert Blum - President and CEOConference Call ParticipantsTessa Romero - Senior Biotech AnalystTessa RomeroWelcome, everyone, to the 44th Annual J.P. Morgan Healthcare Conference. My name is Tessa Romero, and I'm one of the Senior Biotech Analysts here at J.P. Morgan. Our next presenting company is Cytokinetics, and presenting on be ...
Cytokinetics (NasdaqGS:CYTK) Earnings Call Presentation
2026-01-12 12:00
1 Forward-Looking Statements This presentation contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's safe harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements, express or implied, related to Cytokinetics' research and development activities; clinical trial ini ...
美国医疗-2026 前瞻:我们覆盖领域的年度展望-2026 Year Ahead_ What to expect from our coverage universe in 2026
2026-01-08 10:42
Summary of Key Points from the Conference Call Industry Overview - **Industry**: US Biopharmaceuticals - **Performance**: Biopharma ended 2025 positively with NBI up 32% and DRG up 21%, outperforming SPX at 17% [1] - **Outlook for 2026**: Optimism exists despite macro concerns like inflation and tariffs, with easing drug pricing worries, increased M&A activity, new product cycles, and modest expectations positioning the sector favorably [1] Core Insights and Arguments - **Valuation**: Biotech/Pharma P/E multiples are around 19x, which is lower compared to Financials at 18x and Utilities at 20x, indicating potential undervaluation [1] - **Catalysts**: Companies like Insmed (+152%), BridgeBio (+179%), and Travere (+119%) have shown strong performance driven by value-driving catalysts [1] Company-Specific Highlights Insmed - **Performance**: Insmed was a top performer in 2025, driven by Brinsupri's launch and TPIP's phase 2 results [2] - **2026 Outlook**: Continued upside is expected as Brinsupri's uptake alleviates skepticism over the $5B NCFB opportunity [2] BridgeBio - **Focus for 2026**: The debate will center around Attruby, with positive channel checks suggesting potential for accelerated sales [2] - **Key Data**: Anticipation for PROPEL3 readout in January, which could significantly impact the stock [10] Travere - **Performance**: Outperformance in 2025 attributed to commercial success in IgAN [3] - **Approval Outlook**: Filspari's potential approval for FSGS is a major debate, with FDA signals indicating a favorable outlook [9] Cytokinetics - **Market Entry**: Myqorzo's approval for oHCM is expected to face challenges in market execution against established competitors [15][40] - **Upcoming Data**: ACACIA readout in 2Q26 is crucial for assessing the drug's competitive position [19] Tyra - **Expansion**: Tyra is expanding dabogratinib's development into LG-UTUC, which could offer greater regulatory flexibility and market opportunity [43] - **Market Potential**: Management believes an oral option could be a game changer in a relatively underserved market [43] Acumen - **Pipeline Development**: Acumen's EBD program is expected to provide optionality, with initial non-clinical data anticipated early in 2026 [13] - **Key Event**: ALTITUDE-AD is a defining event for Acumen, with expectations for significant data to outperform competitors [33] Additional Important Insights - **M&A Activity**: The biopharma sector is seeing increased M&A activity as companies prepare for patent expirations [1] - **Regulatory Environment**: The FDA's involvement in various drug approvals and feedback mechanisms is crucial for shaping market expectations [9][10] - **Investor Sentiment**: There remains a cautious sentiment among investors, particularly regarding the approval of new drugs and their market uptake [9][19] This summary encapsulates the key points from the conference call, highlighting the overall industry outlook, company-specific developments, and critical upcoming events that could influence market dynamics in the biopharmaceutical sector.
Insider Trading Activity Observed in Cytokinetics, Incorporated (NASDAQ:CYTK)
Financial Modeling Prep· 2026-01-06 03:00
Cytokinetics, Incorporated (NASDAQ:CYTK) is a prominent biopharmaceutical company dedicated to the development of innovative treatments based on muscle biology for serious diseases such as heart failure and amyotrophic lateral sclerosis (ALS). Competing in the dynamic biotech industry against giants like Amgen and Biogen, Cytokinetics has recently been in the spotlight due to significant insider trading activity by its Executive Vice President, Andrew Callos.On January 5, 2026, Andrew Callos executed a nota ...
Cytokinetics to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 21:00
Core Insights - Cytokinetics, Incorporated will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 9:45 AM Pacific Time [1] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [3] - The company’s product MYQORZO™ (aficamten) is approved for treating adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) by the U.S. FDA and the China National Medical Products Administration [3] - The European Medicines Agency has adopted a positive opinion for MYQORZO™ (aficamten), with a decision from the European Commission expected in Q1 2026 [3] - Cytokinetics is also developing omecamtiv mecarbil for heart failure with severely reduced ejection fraction and ulacamten for heart failure with preserved ejection fraction, alongside ongoing pre-clinical research in muscle biology [3]
Cytokinetics Price Target Lifted at Truist Following MYQORZO Approval
Financial Modeling Prep· 2025-12-23 20:46
Core Viewpoint - Truist Securities has raised its price target on Cytokinetics, Inc. to $84 from $70 while maintaining a Buy rating, reflecting updated forecasts following the regulatory approval of MYQORZO [1] Group 1: Regulatory Approval and Market Potential - The recent approval of MYQORZO, which features a differentiated label, positions it to become a significant revenue driver in obstructive hypertrophic cardiomyopathy (oHCM) [2] - Truist updated its model to estimate worldwide peak sales for MYQORZO in oHCM at $3.7 billion, slightly below the $3.8 billion consensus estimate [2] Group 2: Revenue Projections and Launch Expectations - A steady launch of MYQORZO is expected to begin in early 2026, with performance anticipated to be at least comparable to the launch trajectory of Camzyos [3] - Truist modeled fiscal 2026 aficamten revenue at $106 million, aligning with consensus expectations [3] - Looking ahead, the analyst projects worldwide peak adjusted total revenue of $4.6 billion in 2035, marginally above the $4.5 billion consensus estimate [3]