Cytokinetics has announced that the US FDA has approved MYQORZO (aficamten) tablets—available in 5 mg, 10 mg, 15 mg, and 20 mg—for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). 

 

The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity, decreasing cardiac contractility, and reducing left ventricular outflow tract (LVOT) obstruction.

 

“This is a historic moment for our company and for the patients we serve, as we fulfill our promise to translate our science into medicines that may make a meaningful difference in patients’ lives,” said Robert I. Blum, Cytokinetics’ President and CEO. 

 

“Our first FDA approval stands as a testament to the strength of our science and the bold, trailblazing research that has defined Cytokinetics’ leadership in muscle biology. I’m pleased that the approved label and REMS reflect the distinct characteristics of MYQORZO including a straightforward, flexible dosing regimen, no requirement for drug-drug interaction monitoring and a predictable safety profile. 

 

"I am profoundly grateful for the many years of passion and persistence shown by patients with obstructive HCM, as well as healthcare professionals, advocates, partners and employees who have contributed so importantly to reaching this key milestone.”

 

The FDA-approved prescribing information carries a Boxed WARNING highlighting the risk of heart failure. MYQORZO can lower left ventricular ejection fraction (LVEF) and cause systolic dysfunction, requiring echocardiogram monitoring before and during treatment. 

 

The drug is not recommended for patients with LVEF below 55%, with dose adjustments or interruptions required depending on LVEF levels and heart failure symptoms. MYQORZO will be available only through the MYQORZO REMS Program, a restricted program to manage these risks.

 

MYQORZO is expected to reach U.S. pharmacies in the second half of January 2026.

 

“HCM is a heart muscle disease associated with a significant symptom burden. This approval of a new drug, MYQORZO, represents a meaningful addition to the treatment options available for symptomatic obstructive HCM patients,” said Martin Maron, Director of the Hypertrophic Cardiomyopathy Center at Lahey Hospital and Medical Center, and Principal Investigator of SEQUOIA-HCM. 

 

“In SEQUOIA-HCM, MYQORZO improved exercise capacity and reduced symptoms while also being well-tolerated. For these reasons, MYQORZO represents an important step forward in how we care for people living with obstructive HCM.”

 

“Living with symptomatic obstructive HCM means managing physical limitations and burdensome symptoms every day of your life,” said Lisa Salberg, Founder and CEO of the Hypertrophic Cardiomyopathy Association (HCMA). 

 

“For far too long, we’ve had few options to address our needs, and the approval of MYQORZO is a long-awaited and major addition to bring new hope to patients living with oHCM. We are so grateful to the team at Cytokinetics for listening to the patient community and working in true partnership to bring this therapy to so many in need.”