CYTOKINETICS (CYTK) Company Report

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

Cytokinetics Announces FDA Approval of MYQORZO for oHCM

CYTK

Product Launch

Cytokinetics announced on December 19, 2025, that the U.S. Food and Drug Administration (FDA) approved MYQORZO™ (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
This marks Cytokinetics' first FDA-approved medicine, with MYQORZO expected to be available in the U.S. in the second half of January 2026.
The approval is supported by positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, which demonstrated robust efficacy, safety, and clinically meaningful benefits.
MYQORZO's prescribing information includes a Boxed WARNING for the risk of heart failure, necessitating echocardiogram assessments and LVEF monitoring, and it will be available through a restricted MYQORZO REMS Program.
Internationally, MYQORZO was approved in China on December 17, 2025, and received a positive recommendation from the European Medicines Agency on December 12, 2025, with a European Commission decision anticipated in the first quarter of 2026.

Dec 19, 2025, 9:00 PM

Press Release

Cytokinetics Officers and Directors Under Shareholder Investigation

CYTK

Legal Proceedings

Product Launch

Grabar Law Office is investigating Cytokinetics, Inc. (NASDAQ: CYTK) officers and directors for alleged breaches of fiduciary duties, based on a federal securities fraud class action complaint.
The complaint alleges that Cytokinetics made materially false and misleading statements regarding the FDA's review of its New Drug Application (NDA) for aficamten.
Specific allegations include the FDA's decision not to convene an advisory committee on March 10, 2025, and the extension of the Prescription Drug User Fee Act action date from September 26, 2025, to December 26, 2025, to review a Risk Evaluation and Mitigation Strategy (REMS) that was not included in the original NDA.
CEO Robert I. Blum reportedly acknowledged on May 6, 2025, that the company chose to submit the NDA without a REMS despite prior FDA discussions.
Shareholders who purchased CYTK shares prior to December 27, 2023, and still hold them are encouraged to contact Grabar Law Office to seek corporate reforms.

Dec 19, 2025, 1:27 PM

Press Release

Grabar Law Office Investigates Cytokinetics Over Aficamten NDA Disclosures

CYTK

Legal Proceedings

Grabar Law Office is investigating Cytokinetics, Inc. (NASDAQ: CYTK) for alleged breaches of fiduciary duties by its officers and directors, stemming from a federal securities fraud class action complaint.
The investigation focuses on allegations of materially false and misleading statements concerning the company's New Drug Application (NDA) for aficamten.
Key issues include the FDA's decision on March 10, 2025, not to convene an advisory committee meeting for aficamten's NDA.
Additionally, the FDA extended the Prescription Drug User Fee Act (PDUFA) action date for aficamten's NDA from September 26, 2025, to December 26, 2025, to review a Risk Evaluation and Mitigation Strategy (REMS) that was not included in the original NDA.
Cytokinetics' CEO, Robert I. Blum, reportedly acknowledged on May 6, 2025, that the company chose to submit the NDA without a REMS despite prior FDA meetings on safety monitoring and risk mitigation.

Dec 16, 2025, 1:40 PM

Press Release

Cytokinetics' MYQORZO Receives Positive CHMP Opinion

CYTK

Product Launch

New Projects/Investments

Cytokinetics' MYQORZO® (aficamten) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for marketing authorization in the European Union (EU).
This recommendation is for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
A final decision from the European Commission is expected in Q1 2026.
The positive opinion is supported by robust clinical evidence from the pivotal Phase 3 SEQUOIA-HCM trial, which demonstrated MYQORZO's safety and efficacy.
Aficamten is also currently under regulatory review in the U.S., with an FDA Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025, and in China with Priority Review.

Dec 12, 2025, 1:42 PM

Press Release

Cytokinetics discusses aficamten regulatory status, commercial strategy, and pipeline updates

CYTK

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Cytokinetics' lead drug, aficamten, has a PDUFA date of December 26 for obstructive HCM (OHCM) in the US, with potential approvals in China in Q4 and EMA early next year.
The company expects aficamten to offer a differentiated profile and risk mitigation program (REMS) compared to competitors, aiming for wider adoption and increased preference share post-launch.
The ACACIA study for aficamten in non-obstructive HCM (NHCM) is set for a **Q2 data readout **, potentially leading to a supplemental NDA by the end of next year and a 2027 commercial launch.
Cytokinetics projects ending the year with over $1 billion, potentially $1.2 billion, in cash, ensuring a strong financial runway.

Nov 17, 2025, 2:30 PM

Transcript

Cytokinetics provides update on aficamten regulatory status and commercial strategy

CYTK

Product Launch

Guidance Update

New Projects/Investments

Cytokinetics' lead product, aficamten, has a PDUFA date of December 26 for obstructive HCM (OHCM) in the U.S., with anticipated China approval in Q4 and EMA approval early next year.
The Acacia study for non-obstructive HCM (NHCM) is expected to have data readout in Q2 (next year), with a positive outcome potentially leading to a supplemental NDA by the end of next year and a commercial launch in NHCM in 2027.
The company expects to end the year with over $1 billion, closer to $1.2 billion in cash, providing a strong cash runway to support its business ambitions.
Cytokinetics anticipates a differentiated risk mitigation profile for aficamten, potentially leading to a less burdensome REMS program, which could expand prescribing beyond current CMI users and accelerate market penetration.
While the CMI class has seen consistent patient adds of 10,000 per year, Cytokinetics believes aficamten's entry, supported by Maple data and a differentiated profile, could increase net patient adds for the class and result in more new patients than MAVA by the end of next year.

Nov 17, 2025, 2:30 PM

Transcript

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Robert I. Blum

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

Sung H. Lee

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