CYTOKINETICS (CYTK) Company Report

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.

7 days ago

Transcript

Cytokinetics Launches Mycorrhiza for OHCM, Outlines Commercial Strategy and Pipeline Milestones

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 (WAC) of $108,400.
The company's commercial strategy emphasizes a differentiated risk mitigation profile, a unique patient support program, and aims for over 50% market share for new patients and at least 3,800 patients on therapy by year-end 2026.
Cytokinetics expects results from the ACACIA study for Mycorrhiza in non-obstructive HCM (NHCM) in Q2 2026, which could double the potential patient population.
The company reported a strong balance sheet with over $1 billion at the end of Q3 2025 and access to additional capital.

7 days ago

Transcript

Cytokinetics Launches Mycorrhiza for OHCM and Outlines Global Commercial Strategy

CYTK

Product Launch

Guidance Update

New Projects/Investments

Cytokinetics has transitioned to a commercial company following the U.S. FDA approval and launch of Mycorrhiza for adults with obstructive hypertrophic cardiomyopathy (OHCM). Mycorrhiza is also approved in China and is expected to receive European Commission approval in Q1 2026, with market entry in Germany in Q2 2026.
The company's commercial strategy for Mycorrhiza includes a differentiated REMS program and a bespoke patient support service, "Mycorrhiza in You," aimed at enabling greater category growth and penetration. The wholesale acquisition cost (WAC) is set at $108,400, positioning it at parity or a slight premium to competitors.
Key launch metrics for 2026 include achieving at least 50% market share for new patients and parity access by year-end, with an aim to enroll at least 3,800 patients on therapy in the first year.
Significant near-term pipeline catalysts include the expected Q2 2026 readout of the ACACIA study for Mycorrhiza in non-obstructive HCM (NHCM), which could double the addressable market, and a supplemental NDA submission in Q1 2026 based on MAPLE data for potential label expansion.

7 days ago

Transcript

Cytokinetics provides corporate presentation updates on MYQORZO launch, pipeline, and financials

CYTK

Product Launch

New Projects/Investments

Guidance Update

MYQORZO (aficamten) is FDA-approved in the U.S. and China for symptomatic oHCM, with U.S. availability expected in the second half of January 2026 at an annual WAC price of $108,400. An EU approval decision is anticipated in Q1 2026, with a Germany launch planned for Q2 2026.
The company reported a strong financial position with approximately $1.25 billion in cash and investments as of September 30, 2025, and access to additional capital.
Key pipeline milestones for 2026 include the planned sNDA submission for aficamten (MAPLE-HCM) in Q1 2026 and topline results for aficamten (ACACIA-HCM) in Q2 2026.
Cytokinetics projects MYQORZO to achieve over 50% share of new patients by the end of 2026 in the potential $10 billion US + EU market for symptomatic o/nHCM patients.

7 days ago

Presentation

Cytokinetics Faces Shareholder Investigation Over Alleged Misleading Statements

CYTK

Legal Proceedings

Grabar Law Office is investigating Cytokinetics, Inc. (CYTK) for alleged breaches of fiduciary duties by certain officers and directors.
The investigation stems from a federal securities fraud class action complaint alleging materially false and misleading statements regarding the company's New Drug Application (NDA) for aficamten.
Allegations include the FDA's decision not to convene an advisory committee meeting on March 10, 2025, and the extension of the Prescription Drug User Fee Act (PDUFA) action date to December 26, 2025, due to the late submission of a Risk Evaluation and Mitigation Strategy (REMS).
CEO Robert I. Blum reportedly acknowledged on May 6, 2025, that the NDA was submitted without a REMS despite prior discussions with the FDA.

Jan 8, 2026, 1:59 PM

Press Release

CYTK: Imbria Pharmaceuticals Announces Publication of IMPROVE-DiCE Phase 2a Data

CYTK

Product Launch

New Projects/Investments

Imbria Pharmaceuticals announced the publication of full results from the Phase 2a IMPROVE-DiCE clinical trial of ninerafaxstat in Circulation on January 7, 2026.
The trial demonstrated that treatment with ninerafaxstat was associated with improvements in myocardial energy metabolism, enhanced cardiac function, and favorable tolerability in patients with type 2 diabetes mellitus (T2DM), obesity, and heart failure with preserved ejection fraction (HFpEF).
Key findings included a significant improvement in the phosphocreatine to ATP (PCr/ATP) ratio, which was the trial's primary endpoint, along with improvements in systolic augmentation during exercise, patient-reported symptoms, and functional capacity.
Ninerafaxstat is a partial fatty acid oxidation (pFOX) inhibitor under development for cardiac diseases, designed to shift the heart's energy preference from fatty acids to glucose for more efficient mitochondrial energy generation.
Imbria Pharmaceuticals plans to advance clinical development of ninerafaxstat in HFpEF and continue the ongoing Phase 2b FORTITUDE-HCM clinical trial.

Jan 7, 2026, 1:00 PM

Press Release

Cytokinetics Receives FDA Approval for Micorzo

CYTK

Product Launch

New Projects/Investments

The U.S. Food and Drug Administration (FDA) has approved Aficamten (brand name Micorzo) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (OHCM) to improve functional capacity and symptoms.
Micorzo is expected to be available in the U.S. in the second half of January.
The FDA-approved label for Micorzo features a straightforward, flexible dosing regimen and no requirement for drug-drug interaction monitoring (with the exception of rifampin), designed for ease of use for both physicians and patients.
Cytokinetics aims to achieve parity access with criteria coverage for Micorzo by the second half of 2026 and projects market penetration to reach the mid to high 20% range by the end of 2026.
Micorzo has also been approved in China for OHCM, and a positive opinion for marketing authorization in the EU was adopted by the CHMP of the EMA, with a final decision anticipated in Q1 2026 and an EU launch in Q2 2026.

Dec 19, 2025, 9:30 PM

Transcript

Cytokinetics Receives FDA Approval for Myqorzo for Obstructive HCM

CYTK

Product Launch

New Projects/Investments

Cytokinetics announced the FDA approval of aficamten, branded as Myqorzo, for adults with symptomatic obstructive hypertrophic cardiomyopathy (OHCM) to improve functional capacity and symptoms, marking the company's first approved medicine.
Myqorzo will be commercially available in the second half of January, supported by a 125-person sales team.
The approved label and REMS (Risk Evaluation and Mitigation Strategy) are designed for flexibility, ease of use, and convenience, including a straightforward dosing regimen and no requirement for drug-drug interaction monitoring.
Cytokinetics expects to achieve greater than 50% preference share in the cardiac myosin inhibitor category and plans to submit for an expanded label with MAPLE data early in 2026, with a goal of parity access with payers by the second half of 2026.

Dec 19, 2025, 9:30 PM

Transcript

Cytokinetics Announces FDA Approval of Micorzo for OHCM

CYTK

Product Launch

New Projects/Investments

Cytokinetics announced FDA approval of Aficamten, branded as Micorzo, for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (OHCM) to improve functional capacity and symptoms, marking the company's first approved medicine.
The approval is based on positive results from the SEQUOIA-HCM Phase 3 clinical trial, which demonstrated significant improvements in exercise capacity and symptoms.
Micorzo will be available in the U.S. in the second half of January. The label includes a boxed warning for the risk of heart failure but features a flexible dosing regimen and no requirement for drug-drug interaction monitoring.
Cytokinetics anticipates achieving greater than 50% preference share in the cardiac myosin inhibitor category and plans to submit for an expanded label inclusive of MAPLE data early in 2026.

Dec 19, 2025, 9:30 PM

Transcript

Cytokinetics receives FDA approval for MYQORZO™

CYTK

Product Launch

On December 19, 2025, Cytokinetics, Incorporated announced that the U.S. Food and Drug Administration (FDA) approved MYQORZO™ (aficamten).
MYQORZO™ is approved for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
The drug functions as an allosteric and reversible inhibitor of cardiac myosin motor activity, reducing cardiac contractility and left ventricular outflow tract (LVOT) obstruction in oHCM patients.

Dec 19, 2025, 9:01 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for CYTOKINETICS.

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CYTOKINETICS (CYTK)

Analyst Earnings Quarterly Reports

Q4 2024

Q2 2024

Q1 2024

Q4 2023

Executives

Robert I. Blum

Andrew M. Callos

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

Sung H. Lee

Board Members

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.

Analyst Coverage

Jason Butler

Salim Syed

Tessa Romero

Cory Kasimov

James Condulis

Leonid Timashev

Mayank Mamtani

Sean McCutcheon

Yasmeen Rahimi

Akash Tewari

Charles Duncan

Jason Zemansky

Joseph Pantginis

Kyuwon Choi

Roanna Clarissa Ruiz

Srikripa Devarakonda

Ashwani Verma

Cameron Bozdog

David Lebowitz

Gena Wang

Huidong Wang

John Gionco

Leland Gershell

Maxwell Skor

Nikola Gasic

Phoebe Tan

Rohan Mathur

Zaki Molvi

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