CYTOKINETICS (CYTK) Company Report

Cytokinetics achieved significant regulatory milestones with FDA approval of MYQORZO in December 2025, followed by EU and China approvals, transitioning the company to a global commercial-stage entity. The US commercial launch of MYQORZO commenced immediately, with a Germany launch planned for Q2 2026.
Key pipeline advancements for MYQORZO include the submission of a supplemental NDA for MAPLE-HCM, with FDA review anticipated in Q4 2026, and the expected readout of top-line results from the ACACIA-HCM trial in Q2 2026.
Financially, Q4 2025 total revenues were $17.8 million, contributing to a full-year 2025 total revenue of $88 million. The net loss for Q4 2025 was $183 million ($1.50 per share), and $785 million ($6.54 per share) for the full year.
The company reported $1.22 billion in cash, equivalents, and investments at the end of Q4 2025.
For 2026, Cytokinetics provided guidance for GAAP combined R&D and SG&A expense between $830 million and $870 million, or $700 million to $750 million excluding stock-based compensation, but did not provide product sales guidance for MYQORZO.

3 days ago

Transcript

Cytokinetics Reports Q4 2025 Financial Results and MYQORZO Launch Progress

CYTK

Earnings

Product Launch

Guidance Update

Cytokinetics reported Q4 2025 total revenues of $17.8 million and a net loss of $183 million, or $1.50 per share, ending the quarter with approximately $1.22 billion in cash, equivalents, and investments.
The company achieved significant regulatory milestones in Q4 2025 with the FDA approval of MYQORZO (aficamten) in the U.S. and China, and subsequent European Commission approval in the EU.
The U.S. commercial launch of MYQORZO commenced in December 2025, with product availability and initial prescriptions in late January 2026, and the first European launch is planned for Germany in Q2 2026.
For 2026, Cytokinetics provided guidance for GAAP combined R&D and SG&A expenses between $830 million and $870 million, but is not providing product sales guidance for MYQORZO at this time.
Upcoming clinical milestones include the anticipated top-line results from the ACACIA-HCM trial in Q2 2026 and the expected FDA review conclusion for the MAPLE-HCM supplemental NDA in Q4 2026.

3 days ago

Transcript

Cytokinetics Reports Q4 and Full Year 2025 Results, Details MYQORZO Launch and 2026 Outlook

CYTK

Earnings

Product Launch

Guidance Update

Cytokinetics reported total revenues of $17.8 million for Q4 2025 and $88 million for the full year 2025, with a net loss of $183 million for Q4 2025.
The company ended Q4 2025 with approximately $1.22 billion in cash equivalents and investments.
MYQORZO received FDA approval in December 2025, EU approval in February 2026, and China approval in Q4 2025, marking Cytokinetics' transition to a global commercial-stage biopharmaceutical company.
For 2026, Cytokinetics expects GAAP combined R&D and SG&A expenses to be between $830 million and $870 million, but is not providing product sales guidance for MYQORZO at this time.
Key upcoming milestones for 2026 include reporting top-line results from ACACIA-HCM in Q2, launching MYQORZO in Germany in Q2, and potential FDA approval of the supplemental NDA for MAPLE-HCM by Q4.

3 days ago

Transcript

Cytokinetics Announces Q4 2025 Results, MYQORZO Approvals, and 2026 Guidance

CYTK

Earnings

Guidance Update

Product Launch

Cytokinetics reported a net loss of $183.0 million for the fourth quarter of 2025 and $785.0 million for the full year 2025, with total revenues of $17.8 million for Q4 2025 and $88.0 million for the full year 2025.
The company held approximately $1.22 billion in cash, cash equivalents and investments as of December 31, 2025.
MYQORZO (aficamten) received approval in December 2025 from the U.S. FDA for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), with the U.S. commercial launch beginning in January 2026, and also secured approvals in China and Europe.
Cytokinetics provided 2026 financial guidance, projecting GAAP Combined R&D and SG&A Expense to be between $830 million and $870 million. Key upcoming milestones for 2026 include the expected launch of MYQORZO in Germany in Q2 2026, topline results from ACACIA-HCM in Q2 2026, and potential FDA approval of the sNDA for MAPLE-HCM in Q4 2026.

3 days ago

8-K

Cytokinetics Reports Q4 and Full Year 2025 Financial Results, Provides 2026 Guidance, and Updates on MYQORZO Launch

CYTK

Earnings

Guidance Update

Product Launch

Cytokinetics reported a net loss of $183.0 million (or $(1.50) per share) for the fourth quarter of 2025 and $785.0 million (or $(6.54) per share) for the full year 2025, with total revenues of $17.8 million in Q4 2025 and $88.0 million for the full year.
The company maintained a strong financial position with approximately $1.22 billion in cash, cash equivalents, and investments as of December 31, 2025.
For 2026, Cytokinetics provided guidance for GAAP Combined R&D and SG&A Expense between $830 million and $870 million.
MYQORZO received approval in the U.S., China, and Europe in December, with the U.S. commercial launch underway in January and the first European launch planned for Germany in Q2 2026.
Key pipeline updates include the submission of a Supplemental NDA for MAPLE-HCM to the FDA in Q1 2026, with potential approval in Q4 2026, and expected topline results from ACACIA-HCM in Q2 2026.

4 days ago

Press Release

Cytokinetics Receives European Commission Approval for MYQORZO

CYTK

Product Launch

Cytokinetics, Incorporated announced that the European Commission has approved MYQORZO® (aficamten) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy in adult patients.
MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity.

Feb 17, 2026, 12:30 PM

8-K

Cytokinetics Receives European Commission Approval for MYQORZO®

CYTK

Product Launch

Cytokinetics announced that the European Commission (EC) has approved MYQORZO® (aficamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
This approval is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, and the first European launch of MYQORZO is expected in Germany in Q2 2026.
MYQORZO is a cardiac myosin inhibitor that has also been approved by the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA) for the treatment of oHCM.

Feb 17, 2026, 12:30 PM

Press Release

CYTOKINETICS: Heart Failure Drugs Market Forecasted for Significant Growth, Company Advances Phase 3 Trial

CYTK

New Projects/Investments

The global Heart Failure Drugs Market is projected to grow from USD 8.80 Billion in 2025E to USD 28.29 Billion by 2033, exhibiting a CAGR of 15.73% from 2026 to 2033.
This substantial market expansion is primarily driven by global demographic and epidemiological trends, including an aging population and the increasing prevalence of lifestyle-related conditions such as hypertension, diabetes, and obesity.
Cytokinetics, Inc. is recognized as a major player in the Heart Failure Drugs Market.
In December 2024, Cytokinetics initiated a confirmatory Phase 3 trial (COMET-HF) for its drug candidate omecamtiv mecarbil, intended for patients with symptomatic heart failure and severely reduced ejection fraction.

Feb 9, 2026, 9:00 AM

Press Release

Cytokinetics Announces U.S. Launch of MYQORZO

CYTK

Product Launch

New Projects/Investments

Cytokinetics announced that MYQORZO™ (aficamten), a cardiac myosin inhibitor, is now available for prescription in the U.S. for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The U.S. Food and Drug Administration (FDA) approved MYQORZO on December 19, 2025, and its launch signifies Cytokinetics' transition into a commercial biopharmaceutical company.
MYQORZO is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) Program due to a Boxed WARNING for the risk of heart failure.
The drug also received approval in China on December 17, 2025, and is expected to receive marketing authorization in the European Union in the first quarter of 2026.

Jan 27, 2026, 12:30 PM

Press Release

Cytokinetics Announces U.S. Launch of Mycorrhiza and Provides Commercial Strategy Update

CYTK

Product Launch

New Projects/Investments

Guidance Update

Cytokinetics has launched Mycorrhiza in the U.S. for obstructive hypertrophic cardiomyopathy (OHCM) following FDA approval, with a wholesale acquisition cost of $108,400. The drug is also approved in China and anticipates European approval in Q1 2026.
The company targets a successful U.S. launch, aiming for over 50% market share for new patients by year-end and 3,800 or more patients on therapy in the first year.
Key clinical trial results are expected in Q2 2026 from the ACACIA study for Mycorrhiza (aficamten) in non-obstructive HCM (NHCM), which could potentially double the addressable patient population.
Cytokinetics maintains a strong balance sheet with over $1 billion reported at the end of Q3 last year, supporting its ongoing pipeline development for other cardiovascular conditions.

Jan 12, 2026, 5:45 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for CYTOKINETICS.

Q4 2025

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Q3 2025

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CYTOKINETICS (CYTK)

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Robert I. Blum

Andrew M. Callos

Fady I. Malik, M.D., Ph.D.

Sung H. Lee

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B. Lynne Parshall, Esq.

Edward M. Kaye, M.D.

John T. Henderson, M.B., Ch.B.

Muna Bhanji

Nancy J. Wysenski

Robert A. Harrington, M.D.

Robert E. Landry

Wendell Wierenga, Ph.D.

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Tessa Romero

Cory Kasimov

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Joseph Pantginis

Maxwell Skor

Sean McCutcheon

Akash Tewari

Charles Duncan

Jackie Plesset

Jason Zemansky

Kyuwon Choi

Natalie Biafori

Roanna Clarissa Ruiz

Roanna Ruiz

Serge Belanger

Srikripa Devarakonda

Alex

Alexander Xenakis

Ashwani Verma

Cameron Bozdog

David Lebowitz

Gena Wang

Huidong Wang

Joe Pantginis

John Gionco

Leland Gershell

Nikola Gasic

Phoebe Tan

Rohan Mathur

Zaki Molvi

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