MYQORZO (aficamten) Receives ASMR III Rating from the HAS (French National Authority for Health) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy in Adults

PARIS, November 10, 2026 - Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Transparency Committee of the French National Authority for Health (Haute Autorité de Santé, HAS) has granted MYQORZO^® (aficamten) a significant Medical Benefit (Service Médical Rendu, SMR) rating and an ASMR III rating (moderate improvement in medical benefit) for the full scope of its marketing authorization, namely the treatment of adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in New York Heart Association (NYHA) functional classes II and III.¹

"This decision marks an important milestone for Cytokinetics in France," said Sandra Fournier, General Manager of Cytokinetics France. "It recognizes the important contribution of MYQORZO^® to the management of obstructive hypertrophic cardiomyopathy in adults and will support expanding access for patients struggling with the daily burden of this disease."

The Committee based its assessment on SEQUOIA-HCM² and MAPLE-HCM³, the Phase 3 clinical trials of aficamten in oHCM. In SEQUOIA-HCM, MYQORZO^® demonstrated superiority over placebo in improving exercise capacity, clinical symptoms, and quality of life, as well as reducing the duration of eligibility for septal reduction therapy. In MAPLE-HCM, MYQORZO^® demonstrated superiority over metoprolol in improving exercise capacity, clinical symptoms and quality of life.

The Committee also noted the safety profile based on safety data from the clinical trials.

The HAS also recognized the benefits observed in improving functional capacity, symptoms and quality of life, as assessed using the NYHA functional classification and the disease-specific Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS).

Cytokinetics obtained its authorization to operate as a pharmaceutical establishment (établissement pharmaceutique exploitant) in France on August 31, 2026, and continues to pursue its commitment to providing long-term support to healthcare professionals and their patients in the region.

MYQORZO^® is a prescription-only medicine. This press release is intended for healthcare professionals and specialist media.

For full details of the Transparency Committee's assessment, please refer to the complete HAS Transparency Committee opinion: https://www.has-sante.fr/jcms/p_4592681/fr/myqorzo-aficamten

About MYQORZO^® (aficamten)

MYQORZO^® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China and European Union, United Kingdom and Canada for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. HCM can be obstructive when thickened muscle blocks blood flow, or non-obstructive, when blood flow is not blocked but heart function is still affected. In obstructive HCM, the thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller, stiffer and less able to relax and fill with blood. Ultimately, HCM limits the heart's pumping function, leading to reduced exercise capacity and a variety of symptoms.

HCM is the most common monogenic inherited cardiovascular disorder, affecting approximately one out of 350 individuals worldwide.⁴

Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).⁵

People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.⁶ 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.⁷ 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^® 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 the U.S., the European Union, the United Kingdom and Canada.

References

1. Avis Myqorzo: Haute Autorité de Santé [Internet]. MYQORZO (aficamten) - Cardiomyopathie hypertrophique obstructive. Available at: https://www.has-sante.fr/jcms/p_4592681/fr/myqorzo-aficamten
2. SEQUOIA: Maron MS, Masri A, Nassif ME, Barriales-Villa R, Arad M, Cardim N, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. 30 mai 2024;390(20):1849 61
3. MAPLE: Garcia-Pavia P, Maron MS, Masri A, Merkely B, Nassif ME, Peña-Peña ML, et al. Aficamten or Metoprolol Monotherapy for Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. 11 sept 2025;393(10):949 60
4. Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4; 27:200485. doi:10.1016/j.ijcrp.2025.200485.
5. Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552.
6. 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.
7. 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
+1 (415) 290-7757

FR-MYQ-00025