Cytokinetics Announces NMPA Approval of MYQORZO® (aficamten) in China for Patients with Obstructive Hypertrophic Cardiomyopathy

Rhea-AI Summary

Cytokinetics (NASDAQ: CYTK) announced NMPA approval of MYQORZO (aficamten) in China for adults with NYHA class II-III obstructive hypertrophic cardiomyopathy to improve exercise capacity and symptoms.

The approval triggers a $7.5 million milestone payment from Sanofi and leaves Cytokinetics eligible for up to $142.5 million additional development/commercial milestones plus royalties in the low-to-high teens on Greater China net sales. MYQORZO is currently approved only in China.

Regulatory progress noted: a U.S. NDA is under FDA review with a PDUFA date of December 26, 2025, and the EMA CHMP adopted a positive opinion on December 12, 2025, with a European Commission decision expected in Q1 2026.

Positive

• Approval in China for NYHA II-III oHCM
• Approval triggers a $7.5M milestone payment
• Eligible for up to $142.5M in additional milestones
• Royalties projected in the low-to-high teens on China sales
• CHMP positive opinion (Dec 12, 2025) toward EU authorization

Negative

• MYQORZO is approved only in China (limited geography)
• Approval limited to adults with NYHA class II-III oHCM (narrow indication)

Key Figures

China approval milestone $7.5 million Triggered payment from Sanofi upon NMPA approval of MYQORZO in oHCM

Future milestones potential $142.5 million Remaining development and commercial milestones payable by Sanofi

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

Market Reality Check

$61.73 Last Close

Volume Volume 1,437,814 vs 20-day average 1,712,446 ahead of this approval headline. normal

Technical Shares at $62.02, trading above 200-day MA at $45.11, and 10.54% below the 52-week high of $69.33.

Peers on Argus

Peers show mixed, generally modest moves (e.g., AXSM +0.07%, RYTM +0.93%, LEGN -1.37%, ABVX -1.79%, NUVL -1.36%), suggesting this China approval is company-specific rather than a sector-wide driver.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 12	EU CHMP opinion	Positive	+4.3%	Positive CHMP opinion recommending EU authorization for MYQORZO in oHCM.
Nov 18	Inducement grants	Neutral	-1.2%	Inducement equity awards for new hires under Nasdaq Rule 5635(c)(4).
Nov 17	HCM care initiative	Positive	+0.8%	Support for American Heart Association initiative to improve HCM care.
Nov 10	MAPLE-HCM data	Positive	+3.4%	MAPLE-HCM data showing aficamten superiority vs metoprolol on key measures.
Nov 05	Q3 2025 earnings	Neutral	+1.9%	Q3 results with large cash balance and ongoing aficamten regulatory reviews.

Pattern Detected

Recent CYTK news, especially aficamten-related clinical and regulatory updates, has typically seen positive or mildly positive price reactions, indicating the market has rewarded progress on this program.

Recent Company History

Over the last six weeks, Cytokinetics has reported multiple aficamten milestones, including a positive CHMP opinion on Dec 12, 2025 and strong MAPLE-HCM data on Nov 10, 2025, both followed by gains of 4.25% and 3.39%, respectively. Earnings on Nov 5, 2025 highlighted substantial cash of about $1.25 billion and ongoing regulatory reviews. Today’s NMPA approval in China extends that regulatory momentum into a new geography while building on this recent trajectory.

Market Pulse Summary

This announcement highlights NMPA approval of MYQORZO in China for oHCM, triggering a $7.5 million milestone from Sanofi and leaving Cytokinetics eligible for up to $142.5 million in additional milestones plus royalties. It follows recent positive CHMP and clinical data updates for aficamten. Investors may watch upcoming regulatory decisions, including the FDA’s December 26, 2025 PDUFA date and the European Commission ruling in early 2026.

Key Terms

national medical products administration (nmpa) regulatory

"approved by the China National Medical Products Administration (NMPA) for the treatment"

The National Medical Products Administration (NMPA) is China's national regulator that reviews and approves medicines, vaccines, medical devices and cosmetics to ensure they are safe and effective. Investors watch NMPA decisions because its approvals act like a gatekeeper or traffic light for market access—granting permission can unlock sales and growth, while delays, restrictions or rejections can limit revenue, change timelines and increase business risk.

new york heart association (nyha) class ii-iii medical

"adults with New York Heart Association (NYHA) class II-III obstructive hypertrophic"

NYHA Class II–III is a clinical way of grouping people with heart failure by how much their everyday activities are limited: Class II means slight limitation during ordinary tasks, while Class III means marked limitation and symptoms with less-than-ordinary activity, though patients are comfortable at rest. Investors care because these labels define who is enrolled in clinical trials, influence how well a treatment is expected to work, and help estimate the size and urgency of a market—like sorting runners by pace to test a shoe.

obstructive hypertrophic cardiomyopathy (ohcm) medical

"class II-III obstructive hypertrophic cardiomyopathy (oHCM), to improve exercise"

A heart condition in which the muscle of the left ventricle becomes abnormally thick and narrows the pathway that blood must leave through, causing the heart to work harder and sometimes leading to breathlessness, fainting or chest pain; think of a pump whose outlet has become partially blocked. It matters to investors because the condition drives demand for specific drugs, diagnostics, devices and clinical trials, influencing revenue prospects, regulatory risk and long‑term costs for healthcare payers and employers.

hypertrophic cardiomyopathy (hcm) medical

"patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China"

Hypertrophic cardiomyopathy (HCM) is a condition in which the heart muscle becomes abnormally thick, making it harder for the heart to pump blood and sometimes narrowing the flow pathway—think of a pump with walls that have thickened inward. It matters to investors because HCM drives demand for diagnostics, long-term therapies, devices and clinical trials, affects health-care costs and patient outcomes, and can influence regulatory approvals and market opportunities for treatments.

new drug application (nda) regulatory

"the FDA is reviewing a New Drug Application (NDA) for aficamten"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

prescription drug user fee act (pdufa) regulatory

"with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025"

The Prescription Drug User Fee Act (PDUFA) is a law that allows drug companies to pay fees to the government to help speed up the review process for new medicines. This funding aims to ensure that important drugs reach patients faster, which can influence a company's ability to bring products to market efficiently. For investors, PDUFA-related decisions can impact drug approval timelines and company performance.

committee for medicinal products for human use (chmp) regulatory

"the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion"

The Committee for Medicinal Products for Human Use is the group of scientific experts at the European medicines regulator that assesses whether a medicine is safe, effective and high quality for use in people and issues the regulator’s formal scientific opinion. Investors watch its opinions because they act like a building inspector’s stamp for a drug — a positive opinion clears the path to sales across a large market and reduces regulatory risk, while a negative opinion can block or delay commercial plans.

european commission regulatory

"a final decision is anticipated from the European Commission in the first quarter of 2026"

The European Commission is the executive arm of the European Union that proposes and enforces EU laws, manages the EU budget, and represents the bloc in trade and regulatory matters. It matters to investors because its decisions on regulations, competition enforcement, approvals and fines can reshape entire industries, affect company profits and risk, and change where capital flows—much like a referee and rulemaker whose calls influence how the game is played.

AI-generated analysis. Not financial advice.

Approval Triggers Milestone Payment of $7.5 Million from Sanofi; 
Cytokinetics Eligible to Receive Additional Milestone Payments and Royalties on Net Sales in Greater China

SOUTH SAN FRANCISCO, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that MYQORZO® (aficamten) has been approved by the China National Medical Products Administration (NMPA) for the treatment of adults with New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM), to improve exercise capacity and symptoms.

Under the terms of its license and collaboration agreement with Cytokinetics, Sanofi has exclusive rights to develop and commercialize MYQORZO for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. The approval of MYQORZO in oHCM in China triggers a $7.5 million milestone payment from Sanofi to Cytokinetics. Cytokinetics remains eligible to receive up to $142.5 million in development and commercial milestone payments from Sanofi as well as royalties in the low-to-high teens on future sales of MYQORZO in Greater China.

MYQORZO is only approved for use in China. Aficamten is currently under regulatory review in the U.S, where the FDA is reviewing a New Drug Application (NDA) for aficamten with a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2025. On December 12, 2025 the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending marketing authorization in the European Union (EU) for aficamten, and a final decision is anticipated from the European Commission in the first quarter of 2026.

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.¹ 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 is assessing its potential as a treatment that improves exercise capacity as measured by peak oxygen uptake (pVO₂) and relieves symptoms in patients with HCM. MYQORZO was evaluated in SEQUOIA-HCM, a positive pivotal Phase 3 clinical trial in patients symptomatic obstructive hypertrophic cardiomyopathy (HCM). MYQORZO received Breakthrough Therapy Designation for the treatment of symptomatic HCM from the U.S. Food & Drug Administration (FDA) and for the treatment of symptomatic obstructive HCM from the National Medical Products Administration (NMPA) in China.

Aficamten is also currently under clinical investigation in ACACIA-HCM, a Phase 3 trial in patients with non-obstructive HCM and CEDAR-HCM, in a pediatric population with oHCM. Aficamten has not been deemed safe or effective for use in either of these patient populations. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study.

About Hypertrophic Cardiomyopathy

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. HCM is the most common monogenic inherited cardiovascular disorder, with approximately 280,000 patients diagnosed, however, there are an estimated 400,000-800,000 additional patients who remain undiagnosed in the U.S.^2,3,4 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.⁵ 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.⁶ 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 innovation in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction with intention to create a muscle biology franchise business focused on medicines designed to optimize muscle performance for patients with cardiac and other diseases of muscle dysfunction. MYQORZO® (aficamten), the company’s cardiac myosin inhibitor, is approved for the treatment of patients with obstructive hypertrophic cardiomyopathy (HCM) in China, and under regulatory review in the U.S. The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending marketing authorization in the European Union for aficamten, and a final decision is anticipated from the European Commission in the first quarter of 2026. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction, ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction 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.

About the Sanofi and Cytokinetics Collaboration

In 2024, Sanofi acquired exclusive rights to develop and commercialize MYQORZO® (aficamten) from Corxel Pharmaceuticals (CORXEL) for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) in Greater China. Previously, CORXEL acquired the rights to develop and commercialize MYQORZO in Greater China from Cytokinetics in accordance with Cytokinetics’ global registration programs.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, our receipt of regulatory approval by FDA or any other regulatory authority to enable our commercialization of aficamten in the United States or any other jurisdiction by any date, if ever, or our earning or receiving any milestone payments or specific quantum of royalties from commercialization of MYQORZO in Greater China. 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 commercialization activities of Sanofi, the actions of regulatory activities, and the results of our on-going clinical trials. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. 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 C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.

MYQORZO® is a registered trademark of Cytokinetics in China.

References:

1. 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
2. CVrg: Heart Failure 2020-2029, p 44; Maron et al. 2013 DOI: 10.1016/S0140-6736(12)60397-3; Maron et al 2018 10.1056/NEJMra1710575
3. Symphony Health 2016-2021 Patient Claims Data DoF;
4. Maron MS, Hellawell JL, Lucove JC, Farzaneh-Far R, Olivotto I. Occurrence of Clinically Diagnosed Hypertrophic Cardiomyopathy in the United States. Am J Cardiol. 2016; 15;117(10):1651-1654.
5. 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.
6. 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

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

FAQ

What did Cytokinetics announce about MYQORZO in China (CYTK) on December 17, 2025?

Cytokinetics announced NMPA approval of MYQORZO for adults with NYHA class II-III obstructive HCM, triggering a $7.5M milestone from Sanofi.

How much additional money can Cytokinetics (CYTK) receive from Sanofi after the China approval?

Cytokinetics remains eligible for up to $142.5M in development and commercial milestone payments plus royalties in the low-to-high teens.

Is MYQORZO approved anywhere outside China as of December 17, 2025 for CYTK investors?

No; the release states MYQORZO is only approved in China, while U.S. and EU reviews are ongoing.

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

A U.S. NDA is under FDA review with a PDUFA target action date of December 26, 2025.

What is the European regulatory status for aficamten relevant to CYTK?

The CHMP adopted a positive opinion on December 12, 2025, and a European Commission decision is expected in Q1 2026.

What patient population does the China approval of MYQORZO cover for CYTK shareholders?

The approval covers adults with NYHA class II-III obstructive hypertrophic cardiomyopathy to improve exercise capacity and symptoms.