Cytokinetics

Cytokinetics, Inc. is a biopharmaceutical company, which is focused on discovering, developing, and commercializing muscle activators and muscle inhibitors as potential treatments for people with debilitating diseases in which muscle performance is compromised and/or declining. The firm is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Its clinical-stage drug candidates include omecamtiv mecarbil, a novel cardiac myosin activator, CK-136, a novel cardiac troponin activator, reldesemtiv, a novel fast skeletal muscle troponin activator, aficamten, a novel cardiac myosin inhibitor, and CK-3772271, a novel cardiac myosin inhibitor. The company was founded by Ronald D. Vale, Lawrence S. B. Goldstein, James H. Sabry, and James A. Spudich in 1997 and is headquartered in South San Francisco, CA.

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Cytokinetics focuses on aficamten development post-FDA action, eyes international growth

Cytokinetics is navigating challenges post-CRL for omecamtiv mecarbil while focusing on aficamten's development.
Financially, the company is balancing increased expenses with revenue growth and strategic investments in R&D.
Key milestones for 2023 include FDA meetings for omecamtiv mecarbil and data expectations for aficamten.
The company's emphasis on aficamten's differentiation and clinical progress signals a strategic shift in focus.

Cytokinetics shifts focus to cardiovascular pipeline, optimistic outlook ahead

Cytokinetics focusing on cardiovascular pipeline progress, redirecting resources.
Optimistic outlook for aficamten and other cardiovascular drug candidates.
Financially stable with cash reserves and strategic cost-saving measures.

Cytokinetics reports strong Q2 progress, eyes market expansion opportunities

Cytokinetics made significant strides in Q2 2023, advancing key studies and reducing operating spending to enhance financial stability.
Positive data and progress in cardiovascular therapies showcase the company's potential in treating HCM and positioning in the market.
While facing challenges in stock performance and data disclosures, Cytokinetics remains poised for growth with opportunities in novel therapies and market expansion.

Cytokinetics excels in Q3 with aficamten progress and commercial readiness

Cytokinetics demonstrated strong operational and financial performance in Q3 2023, with a focus on advancing the aficamten program and preparing for potential commercialization.
While facing challenges related to data interpretation complexities and real-world beta blocker usage, the company remains well-positioned with compelling clinical aspects of aficamten.
Opportunities lie in potential partnerships for capital access, broad market potential across regions, and upcoming data disclosures driving market differentiation.

Cytokinetics excels with positive aficamten trial results and strategic focus

Cytokinetics' Q4 2023 marked a significant milestone with positive aficamten trial results, strong financial standing, and strategic focus on regulatory advancements and market expansion.
The company's strengths lie in aficamten's efficacy, financial stability, and potential for differentiated labeling, while challenges include adoption transitions and data analysis complexities.
Opportunities abound in accelerating NDA submission, expanding patient reach, engaging with payors, and leveraging data insights for enhanced patient outcomes and market positioning.
Overall, Cytokinetics is poised for growth and impact in 2024, with a clear roadmap for success in advancing aficamten and maximizing its therapeutic potential in the HCM market.

Cytokinetics advances aficamten for HCM treatment amid financial strength

Cytokinetics is making significant strides in advancing aficamten for HCM treatment, supported by positive results and regulatory engagements.
The company's financial strength and strategic focus on commercial readiness position it well for future growth and market penetration.
Challenges lie in addressing unmet needs in pediatric HCM, enrollment completion for ongoing trials, and establishing treatment credibility.
Opportunities exist in expanding diagnosis potential, developing competitive treatment options, and enhancing regulatory alignment for global market access.

Cytokinetics advances obstructive HCM treatment with strong financials and strategic focus

Cytokinetics is poised for growth with FDA submission for aficamten and strong financial position.
Strategic focus on commercial preparations and clinical trials signals a commitment to future success.
Challenges in market competition and education require targeted efforts for successful product launch.
Emphasis on patient-centric approach and category expansion positions the company for market leadership.

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SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The MAA will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP).

Cytokinetics Announces European Medicines Agency Validation of Marketing Authorization Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy

California-based biotech Cytokinetcs (CYTK 4.56%) finished the trading week in style, as its stock price outperformed many other titles by rising nearly 5% on Friday. News of a fresh licensing deal in a key market abroad was the catalyst for the increase, which well exceeded the slightly over 1% gain of the S&P 500 index.

Why Cytokinetics Stock Was a Nearly 5% Winner Today

SOUTH SAN FRANCISCO, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Sanofi will acquire exclusive rights to develop and commercialize aficamten from Corxel Pharmaceuticals (CORXEL) for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. Aficamten is a next-in-class cardiac myosin inhibitor for the potential treatment of patients with HCM.

Cytokinetics Announces Sanofi Acquired Rights to Develop and Commercialize Aficamten in Greater China

Cytokinetics (CYTK) reported earnings 30 days ago. What's next for the stock?

Why Is Cytokinetics (CYTK) Down 9.7% Since Last Earnings Report?

CYTK opens enrollment in the phase III COMET-HF study on omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction.

Cytokinetics Initiates Confirmatory Study on Heart Failure Drug

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that on November 29, 2024 it granted stock options to purchase an aggregate of 34,515 shares of common stock and 22,410 restricted stock units (RSUs) that will be settled into shares of common stock upon vesting to 7 employees, whose employment commenced in November 2024, as a material inducement to their employment.

Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

CYTK's NDA is seeking approval for the lead pipeline candidate, aficamten, which the FDA accepted and assigned a target action date of Sept. 26, 2025.

FDA Accepts Cytokinetics' Application for Cardiovascular Drug

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that COMET-HF (Confirmation of O mecamtiv M ecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure (HF) with severely reduced ejection fraction, is open to enrollment. Omecamtiv mecarbil is a novel investigational selective cardiac myosin activator in development for the potential treatment of heart failure with severely reduced ejection fraction. COMET-HF is being conducted in collaboration with Duke Clinical Research Institute (DCRI), a leading academic research organization.

Cytokinetics Announces Start of COMET-HF, a Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction

SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Company is scheduled to participate in the following December investor conferences:

Cytokinetics to Participate in December Investor Conferences

PDUFA Target Action Date Set for September 26, 2025 SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM).

Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy

Bayer AG

BAYRY enters into a collaboration and license agreement with Cytokinetics for the exclusive development and commercialization of aficamten in Japan.

Bayer Acquires Rights for Cardiovascular Drug From CYTK in Japan

Bayer on Tuesday struck a collaboration deal with U.S. biotech firm Cytokinetics to acquire certain rights in Japan to an experimental heart drug, as the German group strengthens its cardiovascular business with smaller deals.

Bayer acquires rights to Cytokinetics' heart drug in Japan

Approximately €70 Million in Upfront and Near-term Payments to Cytokinetics Up to €490 Million in Commercial Milestone Payments, with Tiered Royalties on Future Sales SOUTH SAN FRANCISCO, Calif. and BERLIN, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) and Bayer today announced they have entered into a collaboration and license agreement for the exclusive development and commercialization of aficamten in Japan for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM), subject to certain reserved development rights of Cytokinetics.

Cytokinetics and Bayer Announce Exclusive Licensing Collaboration for Aficamten in Japan

Two New Analyses from SEQUOIA-HCM Demonstrate Treatment with Aficamten Improves Post-Exercise Oxygen Uptake Recovery and Quality of Life

Cytokinetics Presents New Data Relating to Aficamten and Hypertrophic Cardiomyopathy at the American Heart Association Scientific Sessions 2024

SOUTH SAN FRANCISCO, Calif., Nov. 16, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data from post-hoc analyses of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL.

Cytokinetics Presents Additional Data From GALACTIC-HF at the American Heart Association Scientific Sessions 2024

Advancement of Fast Skeletal Muscle Troponin Activator Expands Pipeline of Muscle-Directed Drug Candidates SOUTH SAN FRANCISCO, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-4015089 (CK-089) in healthy human participants.

Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-4015089

Cytokinetics, Incorporated (CYTK) Q3 2024 Earnings Call Transcript

Cytokinetics (CYTK) came out with a quarterly loss of $1.36 per share versus the Zacks Consensus Estimate of a loss of $1.27. This compares to loss of $1.35 per share a year ago.

Cytokinetics (CYTK) Reports Q3 Loss, Lags Revenue Estimates

Rolling Submission of NDA for Aficamten Completed and Submitted to FDA in Q3 COMET-HF, Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil, and AMBER-HFpEF, Phase 2 Clinical Trial of CK-586, Expected to Begin in Q4 Plan to Advance CK-089, Fast Skeletal Muscle Troponin Activator, into First-In-Human Study in Q4 2024 ~$1.3 Billion in Cash, Cash Equivalents and Investments as of September 30, 2024 SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the third quarter of 2024.

Cytokinetics Reports Third Quarter 2024 Financial Results

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is scheduled to report third quarter results on November 6, 2024 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics' senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company's outlook for the future.

Cytokinetics to Announce Third Quarter Results on November 6, 2024

NDA for Aficamten Submitted to FDA in Q3 COMET-HF, Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil,  and AMBER-HFpEF, Phase 2 Clinical Trial of CK-586, Expected to Begin in Q4 Global Commercial Launch Preparations Underway for First  Potential Approval Towards Building Specialty Cardiovascular Franchise Company Recently Launched Unbranded Disease Awareness Campaign  “HCM Beyond The Heart” for Health Care Professionals SOUTH SAN FRANCISCO, Calif., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) will provide an update on the company's cardiac myosin modulation programs and global commercial launch readiness for aficamten at its Investor and Analyst Day, “Heart Forward: Advancing Cardiac Myosin Modulation,” today at 8:30 AM Eastern Time in New York and streamed live online.

Cytokinetics Highlights Progress in Cardiac Myosin Modulation Programs and Global Commercial Launch Readiness at Investor & Analyst Day

Responder Analyses Show Treatment with Aficamten Demonstrated Improvements on Multiple Assessments of Clinical Significance to Cardiologists

Cytokinetics Presents Additional Data From SEQUOIA-HCM at the HFSA Annual Scientific Meeting

SOUTH SAN FRANCISCO, Calif., Sept. 27, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of A ficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), were presented at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions by Anjali T. Owens, M.D., Medical Director of the Center for Inherited Cardiac Disease and Assistant Professor of Medicine at the University of Pennsylvania.

Cytokinetics Presents Additional Data from SEQUOIA-HCM at the HCMS Scientific Sessions

Program to Provide $100,000 in Support of Communications and Outreach for Patient Advocacy Organizations Focused on Cardiovascular Diseases

Cytokinetics Announces Call for Proposals for Its Seventh Annual Communications Grant Program

Analyses of Effects of Aficamten on Key Clinical Outcomes from SEQUOIA-HCM to be Featured in Late Breaking Clinical Trial Presentation at HFSA

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