Cytokinetics Announces Positive CHMP Opinion of MYQORZO® (Aficamten) for the Treatment of Obstructive Hypertrophic Cardiomyopathy

Rhea-AI Summary

Cytokinetics (Nasdaq: CYTK) announced a positive CHMP opinion recommending EU marketing authorization for MYQORZO (aficamten) to treat symptomatic (NYHA II-III) obstructive hypertrophic cardiomyopathy in adults.

A final European Commission decision is expected in Q1 2026. The CHMP opinion cites clinical evidence from the SEQUOIA-HCM trial. Aficamten is also under review by the FDA with a PDUFA date of Dec 26, 2025 and under Priority Review by China’s NMPA CDE.

Positive

• CHMP issued a positive opinion recommending EU marketing authorization
• Final European Commission decision expected in Q1 2026
• SEQUOIA-HCM clinical evidence cited for safety and efficacy
• FDA PDUFA target action date set for Dec 26, 2025
• China NMPA CDE reviewing aficamten with Priority Review

Negative

• Marketing authorization not final until European Commission decision in Q1 2026
• U.S. approval pending with FDA decision still to occur on Dec 26, 2025

Key Figures

EU decision timing Q1 2026 Expected final European Commission decision on MYQORZO marketing authorization

NYHA class Class II–III Target symptomatic oHCM population for MYQORZO in EU opinion

PDUFA date December 26, 2025 FDA target action date for aficamten NDA in obstructive HCM

Market Reality Check

$60.77 Last Close

Volume Volume 1,725,221 vs 20-day average 1,807,206 (relative volume 0.95x) suggests no unusual trading ahead of this news. normal

Technical Shares at $60.77, trading above the 200-day MA of $44.86 and 12.35% below the 52-week high.

Peers on Argus

CYTK was up 0.75% while close peers showed mixed moves: ABVX up 6.17%, RYTM up 3.42%, AXSM down 0.67%, LEGN down 1.88%, NUVL up 0.39%. This points to a stock-specific context rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 18	Equity inducement grants	Neutral	-1.2%	New-hire equity awards and stock options under Nasdaq inducement rules.
Nov 17	Patient care initiative	Positive	+0.8%	Support for AHA initiative to improve HCM diagnosis and treatment.
Nov 10	Clinical data update	Positive	+3.4%	MAPLE-HCM data showing aficamten superiority vs metoprolol on key measures.
Nov 05	Earnings and update	Neutral	+1.9%	Q3 2025 financials and aficamten regulatory timeline, including PDUFA date.
Nov 04	Investor conferences	Neutral	-0.7%	Announcement of participation in November healthcare investor conferences.

Pattern Detected

Recent CYTK headlines have generally seen modest single-day moves, with positive clinical and regulatory updates (e.g., aficamten data) coinciding with small gains and corporate/administrative items showing limited impact.

Recent Company History

Over the last five events since Nov 4, 2025, Cytokinetics has highlighted late-stage aficamten data, Q3 2025 results, governance and hiring updates, and participation in investor conferences. Notably, the MAPLE-HCM data showing aficamten superiority versus metoprolol coincided with a 3.39% gain, while Q3 earnings and business updates around a December 26, 2025 PDUFA date saw a 1.88% rise. Today’s positive CHMP opinion fits into this progression of advancing aficamten toward global approvals.

Market Pulse Summary

This announcement underscores a major regulatory milestone, with CHMP issuing a positive opinion for MYQORZO in symptomatic oHCM and a final European Commission decision expected in Q1 2026. It complements ongoing regulatory reviews, including an FDA NDA with a December 26, 2025 PDUFA date and a Priority Review in China. Recent history shows aficamten-related updates, such as MAPLE-HCM data, have been key drivers. Investors may watch upcoming regulatory decisions and any commercialization updates as the next catalysts.

Key Terms

European Medicines Agency regulatory

"the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

New Drug Application regulatory

"where the Food & Drug Administration (FDA) is reviewing a New Drug Application (NDA)"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

Prescription Drug User Fee Act regulatory

"with a Prescription Drug User Fee Act (PDUFA) target action date of December"

A federal program that lets drug makers pay fees to the U.S. regulator to fund and speed up the review of new medicines and label changes. Investors care because it affects how quickly a drug can move from testing to market and how predictable approval timelines and regulatory interactions are — like buying a faster lane at a busy checkpoint that can reduce uncertainty about a product’s commercial timing.

Priority Review regulatory

"is reviewing an NDA for aficamten with Priority Review."

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

AI-generated analysis. Not financial advice.

Final Decision from European Commission Expected in Q1 2026

SOUTH SAN FRANCISCO, Calif., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization in the European Union (EU) for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. A final decision is anticipated from the European Commission in the first quarter of 2026.

“We are pleased with CHMP’s positive recommendation based on the robust clinical evidence from SEQUOIA-HCM that demonstrated the safety and efficacy of MYQORZO in patients with oHCM, and we are accelerating commercial readiness activities accordingly,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Given the urgency to bring new treatment options to the European oHCM patient community, pending the final European Commission decision, we look forward to making MYQORZO available to patients in Europe.”

“This positive opinion from the CHMP is an important milestone toward bringing a new treatment option with distinct attributes to patients with oHCM,” said Iacopo Olivotto, M.D., Head of the Cardiomyopathy Center and Professor of Cardiovascular Medicine at the University of Florence, Italy.

Aficamten is currently under regulatory review in the U.S., where the Food & Drug Administration (FDA) is reviewing a New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. Additionally, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) is reviewing an NDA for aficamten with Priority Review.

About SEQUOIA-HCM

The CHMP recommendation for MYQORZO is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints.¹

The results from SEQUOIA-HCM showed that treatment with MYQORZO for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO₂) measured by cardiopulmonary exercise testing (CPET) by 1.8 ml/kg/min compared to baseline in patients treated with MYQORZO versus 0.0 ml/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 - 2.44]; p=0.000002).

The treatment effect of MYQORZO was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy. MYQORZO was well-tolerated, with no instances of worsening heart failure or treatment interruptions due to low left ventricular ejection fraction (LVEF). Treatment emergent serious adverse events occurred in 5.6% and 9.3% of patients on MYQORZO and placebo, respectively. Core lab echocardiographic LVEF was observed to be <50% in 5 patients (3.5%) on MYQORZO compared to 1 patient (0.7%) on placebo.

About MYQORZO® (aficamten)

MYQORZO® (aficamten) is an investigational selective, small molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties.² MYQORZO was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with HCM. In preclinical models, MYQORZO reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state.

The development program for MYQORZO assessed its potential as a treatment that improves exercise capacity and relieves symptoms in patients with obstructive HCM. MYQORZO was evaluated in SEQUOIA-HCM, a positive pivotal Phase 3 clinical trial in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). MYQORZO received Breakthrough Therapy Designation for the treatment of symptomatic HCM from the FDA and for the treatment of symptomatic obstructive HCM from the NMPA in China.

Aficamten is also currently being evaluated in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM; CEDAR-HCM, a clinical trial of aficamten in a pediatric population with oHCM; and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Aficamten was also the subject of MAPLE-HCM, a Phase 3 randomized, double-blind, active-comparator clinical trial in patients with oHCM.

About Hypertrophic Cardiomyopathy

HCM is the most common monogenic inherited cardiovascular disorder, affecting approximately 1 out of 500 Europeans, according to the European Society of Cardiology guidelines.³ Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle (myocardium) becomes abnormally thick (hypertrophied). The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. This ultimately limits the heart’s pumping function, resulting in reduced exercise capacity and symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity.

Two-thirds of patients with HCM have obstructive HCM (oHCM), where the thickening of the cardiac muscle leads to left ventricular outflow tract (LVOT) obstruction, while one-third have non-obstructive HCM (nHCM), where blood flow isn’t impacted, but the heart muscle is still thickened.

People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.⁴ People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes.⁵ A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation.

About Cytokinetics

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. In addition, Cytokinetics is developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function.

For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

Disclaimer

Aficamten, omecamtiv mecarbil, ulacamten and CK-089 are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency.

Forward-Looking Statements

This press release 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 relating to the potential approval of MYQORZO® (aficamten) by FDA, EMA or any other regulatory agency as a treatment for obstructive hypertrophic cardiomyopathy or any other indication, Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO is a registered trademark of Cytokinetics in the European Union.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

References

1. Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. DOI: 10.1056/NEJMoa2401424
2. Chuang C, Collibee S, Ashcraft L, et al. Discovery of Aficamten (CK-274), a Next-Generation Cardiac Myosin Inhibitor for the Treatment of Hypertrophic Cardiomyopathy. J Med Chem. 2021;64(19):14142–14152. https://doi.org/10.1021/acs.jmedchem.1c01290
3. ESC Clinical Practice Guidelines. ESC European Society of Cardiology. Accessed July 23, 2025. https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Cardiomyopathy-Guidelines
4. Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260.
5. Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic cardiomyopathy. Current Opinion in Cardiology. 2022 Jan 1;37(1):15-21
   

FAQ

What did Cytokinetics announce about MYQORZO (aficamten) on December 12, 2025?

Cytokinetics announced a positive CHMP opinion recommending EU marketing authorization for MYQORZO for symptomatic oHCM in adults.

When will the European Commission make a final decision on CYTK's MYQORZO EU approval?

A final decision from the European Commission is expected in Q1 2026.

What clinical trial supported the CHMP positive opinion for aficamten (CYTK)?

The CHMP opinion referenced clinical evidence from the SEQUOIA-HCM trial demonstrating safety and efficacy.

What is the U.S. regulatory timeline for aficamten (CYTK)?

The FDA is reviewing an NDA for aficamten with a PDUFA target action date of Dec 26, 2025.

Is aficamten under review in China and what is its status?

Yes; the China NMPA Center for Drug Evaluation is reviewing an NDA for aficamten with Priority Review.

How soon could MYQORZO become available to patients in Europe if approved?

If the European Commission grants authorization in Q1 2026, the company plans to accelerate commercial readiness to make MYQORZO available to European patients.