Cytokinetics Announces MHRA Marketing Authorisation for MYQORZO®▼ (aficamten) and Positive Guidance from NICE for Symptomatic Obstructive Hypertrophic Cardiomyopathy in England and Wales

Rhea-AI Summary

Cytokinetics (Nasdaq: CYTK) announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for MYQORZO (aficamten) to treat symptomatic (NYHA class II‑III) obstructive hypertrophic cardiomyopathy (oHCM) in eligible adult patients across the United Kingdom.

Simultaneously, the National Institute for Health and Care Excellence (NICE) issued positive guidance recommending aficamten as an option for eligible adults with symptomatic oHCM in England and Wales, as add‑on to optimised standard care or alone when those therapies are contraindicated, subject to a commercial arrangement. Authorisation relied on phase 3 SEQUOIA‑HCM data in 282 adults, where aficamten showed a statistically significant improvement in peak oxygen uptake versus placebo (least squares mean difference 1.7 mL/kg/min; p < 0.001). MYQORZO is under additional safety monitoring, and healthcare professionals are asked to report suspected adverse reactions via the MHRA Yellow Card Scheme.

Positive

• MHRA marketing authorisation for MYQORZO (aficamten) in symptomatic NYHA II‑III oHCM adults across the UK
• NICE positive guidance recommending aficamten for eligible symptomatic oHCM adults in England and Wales under a commercial arrangement
• SEQUOIA‑HCM phase 3 met primary endpoint: pVO2 +1.8 vs 0.0 mL/kg/min; LS mean difference 1.7; p < 0.001

Negative

• Additional safety monitoring required; MYQORZO is subject to enhanced pharmacovigilance via the MHRA Yellow Card Scheme
• Reported adverse reactions: hypertension 7.7%, palpitations 7.0%, dizziness 4.2%, systolic dysfunction 3.5% in clinical data

News Explained

The UK regulatory decisions are complete, but NHS access is not yet stated as available: Cytokinetics expects availability later this year, and NICE use in England and Wales remains subject to a commercial arrangement.

News Market Reaction – CYTK

+2.60%

6 alerts

+2.60% Session close to close

$10.48B Market Cap

0.7x Rel. Volume

In the Jul 30 session, CYTK gained 2.60%, reflecting a moderate positive market reaction. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

Recent CYTK news reactions included -1.44% and -1.33%, adding a company-specific comparison to this ...

Analysis

Recent CYTK news reactions included -1.44% and -1.33%, adding a company-specific comparison to this regulatory milestone. Net Selling insider activity is a sourced risk factor; UK access timing and the reported safety profile remain relevant to monitor.

Key Figures

Trial sample size: 282 adults Treatment duration: 24 weeks Mean peak oxygen uptake change: 1.8 mL/kg/min vs. 0.0 mL/kg/min +4 more

7 metrics

Trial sample size 282 adults Phase 3 SEQUOIA-HCM study; 142 aficamten and 140 placebo

Treatment duration 24 weeks Phase 3 SEQUOIA-HCM study

Mean peak oxygen uptake change 1.8 mL/kg/min vs. 0.0 mL/kg/min Aficamten versus placebo at Week 24

Least squares mean difference 1.7 mL/kg/min Aficamten versus placebo at Week 24

95% confidence interval 1.0 to 2.4 mL/kg/min Least squares mean difference

P-value p < 0.001 Primary endpoint comparison

Common adverse reactions Hypertension 7.7%; palpitations 7.0%; dizziness 4.2%; systolic dysfunction 3.5% Aficamten safety data

Historical Context

5 past events · Latest: Jul 23 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jul 23	Earnings date notice	Neutral	-1.4%	Scheduled second-quarter results and conference call for August 6, 2026.
Jul 17	Inducement equity grants	Neutral	-1.3%	Granted inducement options and RSUs to 10 newly hired employees.
Jul 07	Clinical presentation announcement	Neutral	-0.0%	Announced three late-breaking ESC abstracts, including Phase 3 ACACIA-HCM results.
Jun 17	Inducement equity grants	Neutral	+0.9%	Granted inducement options, RSUs, and PSUs to 12 recent hires.
Jun 08	Corporate giving program	Neutral	-5.0%	Opened 2026 corporate giving program with donations up to $20,000.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent company news events were followed predominantly by negative or near-flat 24-hour reactions, including several neutral announcements.

Key Terms

pvo2, cardiac myosin inhibitor, lvot obstruction, confidence interval

4 terms

pvo2 medical

"The primary endpoint was the change from baseline to Week 24 in peak oxygen uptake (pVO2)"

PvO2 is the partial pressure of oxygen in venous blood — a measure of how much oxygen remains in the blood after tissues have taken what they need. Think of it like checking the water level in a used bucket to gauge how much was consumed; low PvO2 can signal poor oxygen delivery or high tissue demand, while high PvO2 can mean reduced uptake. Investors watch PvO2 when it’s used as a clinical measurement or trial endpoint because changes can indicate whether a drug, device, or treatment meaningfully improves patient oxygenation and safety, which affects regulatory decisions and market value.

cardiac myosin inhibitor medical

"Aficamten is a cardiac myosin inhibitor authorised in the United Kingdom"

A cardiac myosin inhibitor is a type of drug that directly reduces the force of heart muscle contractions by blocking the motor protein (myosin) that drives each heartbeat; think of it as slightly easing the pressure on an overworking engine so it doesn’t overexert itself. It matters to investors because these medicines can change treatment options, regulatory pathways, and revenue prospects for companies developing therapies for conditions where the heart is too strong or stressed, while carrying clinical and safety risks that affect valuation.

lvot obstruction medical

"left ventricular outflow tract (LVOT) obstruction"

Left ventricular outflow tract (LVOT) obstruction is a narrowing or blockage where blood leaves the heart’s left ventricle and enters the aorta, caused by structural abnormalities or dynamic motion of heart tissue. Picture a doorway or pipe that becomes partly blocked, forcing blood to push harder and reducing flow. It matters to investors because its prevalence, treatments, medical devices, and drug trials can affect healthcare spending, regulatory approvals, and the commercial prospects of companies in cardiology.

confidence interval technical

"95% confidence interval 1.0 to 2.4"

An interval estimate that shows a range of values within which a true number (like a company’s expected earnings, a projected return, or a model input) is likely to lie, together with a stated level of confidence in that range. For investors it turns a single point forecast into a band—like a weather forecast saying 60–70°F instead of just 65°F—making uncertainty explicit so you can judge risk and size positions more sensibly.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Authorisation from MRHA and Recommendation from NICE

This announcement is intended for business and financial media and investors only 

SOUTH SAN FRANCISCO, Calif., July 30, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted MYQORZO® (aficamten) a marketing authorisation across the United Kingdom for the treatment of symptomatic (New York Heart Association, NYHA class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in eligible adult patients. At the same time the National Institute for Health and Care Excellence (NICE) has issued guidance recommending aficamten for use in eligible adult patients in England and Wales.

The guidance from NICE states that aficamten can be used as an option to treat symptomatic oHCM in eligible adults with a NYHA class of II to III. It can only be used as an add-on to individually optimised standard care including beta-blockers, non-dihydropyridine calcium-channel blockers or disopyramide, or alone if these treatments are contraindicated, and if the company provides it according to the commercial arrangement.

“We are pleased to have secured a marketing authorisation for aficamten and to see positive guidance from NICE for eligible adult patients in England and Wales,” said Joseph Dagher, Senior Vice President and Head of Europe, Cytokinetics. “We are grateful for the collaborations that made this review possible for concurrent MHRA and NICE decisions and are committed to supporting access for eligible adult patients through the NHS upon availability expected later this year.”

The MHRA assessment of aficamten drew on data from SEQUOIA-HCM, a phase 3 multicentre double-blind placebo-controlled randomised study in 282 adults (142 aficamten, 140 placebo) treated for 24 weeks.¹ The primary endpoint was the change from baseline to Week 24 in peak oxygen uptake (pVO₂) measured by cardiopulmonary exercise testing. Aficamten resulted in a statistically significant improvement in peak oxygen uptake compared with placebo (mean change 1.8 mL/kg/min with aficamten versus 0.0 mL/kg/min with placebo; least squares mean difference 1.7 mL/kg/min, 95% confidence interval 1.0 to 2.4; p < 0.001).¹ Further information, including efficacy and safety data, is provided in the aficamten Summary of Product Characteristics.²

The most commonly reported adverse reactions with aficamten were hypertension (7.7%), palpitations (7.0%), dizziness (4.2%) and systolic dysfunction (3.5%).²

▼ MYQORZO (aficamten) is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or by searching for MHRA Yellow Card in the Google Play or Apple App Store.

About Aficamten

Aficamten is a cardiac myosin inhibitor authorised in the United Kingdom for the treatment of symptomatic (NYHA class II-III) oHCM in eligible adult patients. In patients with oHCM, myosin inhibition with aficamten reduces cardiac contractility and, consequently, left ventricular outflow tract (LVOT) obstruction. Aficamten has a predictable exposure-response relationship and a reversible mechanism of action.¹

About Obstructive Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. In oHCM, thickened heart muscle blocks blood flow, and the inside of the left ventricle becomes smaller, stiffer and less able to relax and fill with blood. This 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 1 out of 500 Europeans, according to European Society of Cardiology guidelines.³ Approximately half of patients with HCM have oHCM.⁴

People with oHCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.⁵ People with oHCM are at risk of potentially fatal ventricular arrhythmias, which is one of the leading causes of sudden cardiac death in younger people or athletes.⁶ A subset of patients with oHCM 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 additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.

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 enrollment, expected results or timing of completion of any of our clinical trials, the clinical meaningfulness, persuasiveness or interpretation of clinical trial results, including for purposes of regulatory approval, labeling, or market acceptance, the results of long-term, secondary or exploratory analyses, including analyses of time to first cardiovascular event, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten, or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. 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, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission including the risk factors included in Cytokinetics' most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.

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 and the United Kingdom.

References

1. Maron MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424
2. MYQORZO (aficamten) UK Summary of Product Characteristics. Available from Cytokinetics upon request
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. Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552
5. Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, 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 the July 30, 2026 MHRA decision mean for Cytokinetics (CYTK) and MYQORZO (aficamten)?

The MHRA granted MYQORZO (aficamten) marketing authorisation across the UK for eligible adults with symptomatic obstructive hypertrophic cardiomyopathy. According to Cytokinetics, this authorisation enables use in NYHA class II‑III oHCM patients and was supported by phase 3 SEQUOIA‑HCM clinical trial data.

How did NICE guidance in England and Wales affect access to MYQORZO (aficamten) for CYTK?

NICE issued positive guidance recommending aficamten as an option for eligible adults with symptomatic oHCM in England and Wales. According to Cytokinetics, use is as add‑on to optimised standard care, or alone when contraindicated, and depends on the company’s commercial arrangement.

For which patients is MYQORZO (aficamten) authorised following the MHRA approval for CYTK?

MYQORZO is authorised in the UK for eligible adult patients with symptomatic obstructive hypertrophic cardiomyopathy, NYHA class II‑III. According to Cytokinetics, treatment targets adults whose disease involves left ventricular outflow tract obstruction and is used within optimised care pathways.

What were the key SEQUOIA-HCM phase 3 results supporting MYQORZO (aficamten) approval for CYTK?

In SEQUOIA-HCM, aficamten showed a statistically significant improvement in peak oxygen uptake versus placebo at 24 weeks. According to Cytokinetics, mean change was 1.8 mL/kg/min with aficamten versus 0.0 with placebo, with a least squares mean difference of 1.7 and p < 0.001.

What safety profile and adverse reactions are associated with MYQORZO (aficamten) for CYTK investors to consider?

The most commonly reported adverse reactions were hypertension, palpitations, dizziness and systolic dysfunction. According to Cytokinetics, MYQORZO is subject to additional monitoring, and healthcare professionals are encouraged to report suspected adverse reactions via the MHRA Yellow Card Scheme.

When is MYQORZO (aficamten) expected to become available through the NHS after MHRA and NICE decisions?

Cytokinetics expects MYQORZO to be available to eligible adult oHCM patients through the NHS later in 2026. According to Cytokinetics, the company is committed to supporting access following the concurrent MHRA authorisation and NICE positive guidance.

How must MYQORZO (aficamten) be used alongside standard care under NICE guidance for CYTK’s therapy?

NICE recommends aficamten as an option only as add-on to individually optimised standard care or alone if those treatments are contraindicated. According to Cytokinetics, use is also conditional on the company providing it under the agreed commercial arrangement.