SOUTH SAN FRANCISCO, Calif., July 30, 2026
Cytokinetics, Incorporated has achieved a major regulatory and market access milestone for MYQORZO® (aficamten) in the United Kingdom, with the Medicines and Healthcare products Regulatory Agency (MHRA) granting marketing authorisation for the treatment of eligible adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). At the same time, the National Institute for Health and Care Excellence (NICE) issued positive guidance recommending aficamten for eligible adult patients in England and Wales. The authorisation covers adults with New York Heart Association (NYHA) class II–III symptomatic oHCM, while NICE recommends the therapy as an add-on to individually optimized standard care, including beta-blockers, non-dihydropyridine calcium-channel blockers or disopyramide, or as monotherapy when those treatments are contraindicated. Cytokinetics expects to support patient access through the National Health Service (NHS) following anticipated availability later in 2026.
MHRA Authorisation Opens New Treatment Option for oHCM
The MHRA marketing authorisation for MYQORZO represents an important advancement for Cytokinetics’ cardiovascular portfolio and provides a new therapeutic option for adults living with symptomatic oHCM across the United Kingdom. Aficamten is a cardiac myosin inhibitor designed to reduce excessive cardiac contractility and consequently decrease left ventricular outflow tract (LVOT) obstruction, a defining characteristic of obstructive hypertrophic cardiomyopathy. The therapy has a predictable exposure-response relationship and a reversible mechanism of action. NICE’s simultaneous positive guidance further strengthens the pathway toward patient access in England and Wales. Under the recommendation, aficamten may be administered alongside individually optimized standard therapy or used alone when existing treatments are contraindicated, subject to the agreed commercial arrangement. Cytokinetics said it is committed to supporting access for eligible patients through the NHS once the medicine becomes available later this year.
Phase 3 SEQUOIA-HCM Data Support Aficamten Authorisation
The MHRA assessment of aficamten was supported by results from the pivotal Phase 3 SEQUOIA-HCM study, a multicenter, randomized, double-blind and placebo-controlled trial involving 282 adults with symptomatic oHCM. Participants received either aficamten or placebo for 24 weeks, with the study’s primary endpoint measuring change from baseline in peak oxygen uptake (pVO2) through cardiopulmonary exercise testing. Aficamten produced a statistically significant improvement in peak oxygen uptake, with a mean change of 1.8 mL/kg/min compared with 0.0 mL/kg/min for placebo. The least-squares mean difference was 1.7 mL/kg/min, with a 95% confidence interval of 1.0 to 2.4 and p<0.001. According to the product information cited by Cytokinetics, the most commonly reported adverse reactions included hypertension at 7.7%, palpitations at 7.0%, dizziness at 4.2%, and systolic dysfunction at 3.5%. MYQORZO is also subject to additional monitoring in the UK to facilitate rapid identification of new safety information.
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MYQORZO Expands Options for Symptomatic Heart Disease
Hypertrophic cardiomyopathy (HCM) is characterized by abnormal thickening of the heart muscle, while in obstructive disease this thickened tissue restricts blood flow and can reduce the heart’s ability to relax and fill efficiently. The condition can lead to reduced exercise capacity, cardiovascular complications, heart failure, and potentially serious ventricular arrhythmias. HCM is considered the most common monogenic inherited cardiovascular disorder and affects approximately one in 500 Europeans, with roughly half of patients estimated to have the obstructive form. The combination of MHRA marketing authorisation and positive NICE guidance therefore represents a significant milestone for Cytokinetics as it works to establish aficamten as a targeted treatment for eligible patients with symptomatic oHCM. The decision also strengthens the company’s position in cardiovascular biopharmaceutical innovation following more than 25 years of research focused on muscle biology and next-generation medicines.
Source: Cytokinetics press release
