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The FDA is expected to decide on Myqorzo for Obstructive hypertrophic cardiomyopathy, MAPLE-HCM label update by November 14, 2026, under a sNDA from Cytokinetics.
What is being decided
Cytokinetics has a sNDA under FDA review for Myqorzo (aficamten) in Obstructive hypertrophic cardiomyopathy, MAPLE-HCM label update. Myqorzo has been approved since December 2025 for adults with symptomatic obstructive hypertrophic cardiomyopathy. This supplemental application asks the FDA to add results from the Phase 3 MAPLE-HCM trial, which compared Myqorzo alone with metoprolol alone. Metoprolol is a beta blocker, the first drug the 2024 AHA/ACC guideline recommends for symptoms of obstructive HCM. Cytokinetics has not said what label wording it is seeking.
Who this decision matters to
Familial hypertrophic cardiomyopathy is a genetic heart muscle disease characterized by inappropriate left ventricular hypertrophy and diastolic dysfunction. Caused by mutations in genes encoding sarcomeric proteins, it increases risk of sudden cardiac death and heart failure.
Genetic testing identifies at-risk family members, and the FDA has approved 2 cardiac myosin inhibitors, Camzyos (mavacamten) and Myqorzo (aficamten), for symptomatic obstructive HCM.
Prevalence: 1 in 500 people; 50% of first-degree relatives of affected individuals inherit the mutation. See our full Familial Hypertrophic Cardiomyopathy page for current treatments, recruiting trials, and community resources.
About the drug
Myqorzo: oral allosteric, reversible cardiac myosin inhibitor that reduces the excess force of heart muscle contraction, easing the outflow blockage in obstructive hypertrophic cardiomyopathy. Our full Myqorzo profile covers how it works, side effects in plain language, and its trial history.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Familial Hypertrophic Cardiomyopathy treatment stands today
Read our full Familial Hypertrophic Cardiomyopathy treatment summary
Two cardiac myosin inhibitors are FDA approved for symptomatic obstructive hypertrophic cardiomyopathy: mavacamten (Camzyos), approved for adults in April 2022 and for children weighing at least 30 kg on September 30, 2026, and aficamten (Myqorzo), approved for adults in December 2025. Both require echocardiograms before and during treatment and are available only through restricted safety programs (REMS) because they can weaken the heart's pumping and cause heart failure.
Gene therapy approaches remain investigational. Myosin inhibitors selectively reduce force generation by hypercontractile sarcomeres, improving diastolic function and reducing LVOT obstruction.
Gene therapy approaches aim to correct or mitigate effects of pathogenic mutations. Genetic testing identifying specific mutations guides family screening and risk stratification, with important implications for relatives of affected individuals.
Implantable cardioverter-defibrillators (ICDs) protect high-risk patients from sudden cardiac death. Cardiac rehabilitation, activity modification, and heart failure management optimize exercise tolerance and quality of life.
The Hypertrophic Cardiomyopathy Association connects patients with specialists experienced in genetic heart disease and maintains trial registries. Work with cardiologists experienced in genetic heart disease for comprehensive risk assessment and access to latest therapies.
The Familial Hypertrophic Cardiomyopathy page has every treatment and trial →Meanwhile, 12 Familial Hypertrophic Cardiomyopathy studies are enrolling
Whatever the FDA decides here, research on Familial Hypertrophic Cardiomyopathy does not stop. Of these, 1 tests a treatment; the others follow patients over time. The most recently updated:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Familial Hypertrophic Cardiomyopathy. Unsubscribe anytime.
You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Familial Hypertrophic Cardiomyopathy. Turn any of these off from the link in every email.
Frequently asked questions
When will the FDA decide on Myqorzo?
The FDA's target date (PDUFA date) for Myqorzo in Obstructive hypertrophic cardiomyopathy, MAPLE-HCM label update is November 14, 2026.
Who disclosed it: Cytokinetics. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
What is Myqorzo being reviewed for?
Cytokinetics submitted a sNDA for Myqorzo in Obstructive hypertrophic cardiomyopathy, MAPLE-HCM label update.
What to know: Myqorzo has been approved since December 2025 for adults with symptomatic obstructive hypertrophic cardiomyopathy. This supplemental application asks the FDA to add results from the Phase 3 MAPLE-HCM trial, which compared Myqorzo alone with metoprolol alone. Metoprolol is a beta blocker, the first drug the 2024 AHA/ACC guideline recommends for symptoms of obstructive HCM. Cytokinetics has not said what label wording it is seeking.
How it works: Oral allosteric, reversible cardiac myosin inhibitor that reduces the excess force of heart muscle contraction, easing the outflow blockage in obstructive hypertrophic cardiomyopathy.
More: the Myqorzo drug page explains it in plain language.
Is there already an FDA-approved treatment for Familial Hypertrophic Cardiomyopathy?
Yes. Trial Friend's drug list includes 2 FDA-approved drugs for Familial Hypertrophic Cardiomyopathy.
Approved: Camzyos (mavacamten), Myqorzo (aficamten).
Check: the Familial Hypertrophic Cardiomyopathy page also searches FDA drug labels for approved treatments.
What did the Myqorzo trials show?
Approval rested on SEQUOIA-HCM (NCT05186818), a Phase 3 trial of 282 adults with symptomatic obstructive HCM (NYHA class II or III) randomized to Myqorzo or placebo for 24 weeks. Peak oxygen uptake on an exercise test (pVO2, a measure of exercise capacity), the main goal, rose 1.7 mL/kg/min on Myqorzo against no change on placebo.
More: the Myqorzo drug page has the full trial history and sources.
What are the side effects of Myqorzo?
Myqorzo has a boxed warning for heart failure. By reducing the heart's squeezing force, it lowers left ventricular ejection fraction (LVEF, the share of blood pumped out with each beat) and can cause heart failure from weak pumping (systolic dysfunction).
Most common: High blood pressure (8% against 2% on placebo), Reversible LVEF drop below 50% (4% against 1%).
Boxed warning: Risk of heart failure. Myqorzo reduces LVEF and can cause heart failure due to systolic dysfunction. Echocardiograms are required before and during treatment. Starting it with LVEF below 55% is not recommended; the dose is lowered if LVEF is below 50% and at least 40%, and paused if LVEF is below 40% or heart failure symptoms or worsening clinical status appear. Available only through the Myqorzo REMS Program.
More: the Myqorzo drug page lists the warnings in full.
Can I get Myqorzo before the FDA decides?
Myqorzo is already FDA approved for other conditions, but not yet for Obstructive hypertrophic cardiomyopathy, MAPLE-HCM label update, and insurers may not cover use for an unapproved condition.
Trials: 12 Familial Hypertrophic Cardiomyopathy studies are enrolling now, 1 of them testing a treatment. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Cytokinetics directly. Registered programs are listed on ClinicalTrials.gov.
How much will Myqorzo cost?
Myqorzo is already sold in the US for other conditions. Trial Friend does not list a price, and coverage for Obstructive hypertrophic cardiomyopathy, MAPLE-HCM label update depends on the FDA decision and your insurer.
Drugmaker help: MYQORZO & You (Cytokinetics).
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Myqorzo decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Cytokinetics press release, May 5 2026. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.