1. Cytokinetics' MYQORZO receives FDA approval for obstructive HCM treatment. 2. MYQORZO improves functional capacity in patients with oHCM. 3. FDA approval arises from positive SEQUOIA-HCM trial results. 4. MYQORZO is Cytokinetics' first FDA-approved medicine. 5. Patient support programs will assist those prescribed MYQORZO.
FAQ
Why Very Bullish?
The FDA approval of MYQORZO represents a significant milestone for Cytokinetics. Historical data shows that FDA approvals often lead to substantial stock price increases for biotech firms.
How important is it?
MYQORZO's approval could significantly enhance revenue potential, market position, and investor confidence for Cytokinetics.
Why Short Term?
Immediate impact anticipated as market reacts to MYQORZO's approval news. FDA approvals typically drive price surges shortly after the announcement.
Cytokinetics Secures FDA Approval for MYQORZO™ (aficamten) to Treat Obstructive Hypertrophic Cardiomyopathy
Cytokinetics, Incorporated (Nasdaq: CYTK), announced a significant milestone today with the U.S. Food and Drug Administration's (FDA) approval of MYQORZO™ (aficamten) for the treatment of adults suffering from symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This groundbreaking approval, based on the pivotal SEQUOIA-HCM trial, marks the first FDA-sanctioned therapeutic option from Cytokinetics aimed at enhancing functional capacity and alleviating symptoms in oHCM patients.
Details of FDA Approval
MYQORZO is available in multiple dosages: 5 mg, 10 mg, 15 mg, and 20 mg tablets. As a cardiac myosin inhibitor, it directly addresses the underlying hypercontractility that characterizes oHCM by reducing cardiac contractility and left ventricular outflow tract (LVOT) obstruction.
“This is a historic moment for our company and for the patients we serve,” stated Robert I. Blum, President and CEO of Cytokinetics. “Our first FDA approval exemplifies the strength of our research and our commitment to advancing treatments that significantly improve patient outcomes.”
Safety and Risk Management
The full U.S. prescribing information for MYQORZO includes a boxed warning concerning the risk of heart failure associated with decreased left ventricular ejection fraction (LVEF). Regular echocardiograms will be mandatory before and throughout the treatment process to monitor potential systolic dysfunction.
- Initiation of MYQORZO is not recommended if LVEF is less than 55%.
- Dosage adjustments are required if LVEF falls below specific thresholds during treatment.
- MYQORZO is available exclusively through a restricted program under the Risk Evaluation and Mitigation Strategy (REMS).
Availability and Patient Support
MYQORZO is projected to be available in the U.S. in the second half of January 2026. Cytokinetics will also launch the MYQORZO & You™ program, designed to assist patients on their treatment journey by providing education and support for insurance benefit investigations.
For further assistance, patients can reach out at 833-MYQORZO (833-697-6796).
Clinical Trial Highlights
The FDA’s approval relies on data from the SEQUOIA-HCM trial, which demonstrated notable efficacy across various outcomes including symptom relief, exercise capacity, and hemodynamic improvements. Key findings revealed:
- MYQORZO significantly improved peak oxygen uptake (pVO2) by 1.8 mL/kg/min over placebo.
- Class 1 treatment-related serious adverse events occurred in 5.6% of patients on MYQORZO.
- Only 3.5% of patients on MYQORZO had LVEF below 50%, compared to 0.7% on placebo.
Expert Opinions
“The approval of MYQORZO represents a substantial advancement in treatment options for patients with symptomatic obstructive HCM,” stated Dr. Martin Maron, Principal Investigator of SEQUOIA-HCM.
Lisa Salberg, CEO of the Hypertrophic Cardiomyopathy Association, emphasized the long-term need for better treatment options, stating, "MYQORZO is a long-awaited addition that brings new hope to those living with obstructive HCM."
Investor Conference Information
Cytokinetics will discuss the FDA approval of MYQORZO during an investor conference call today, December 19, 2025, at 4:30 PM Eastern Time. Interested parties can register at this link. A recorded version of the call will be accessible on the Cytokinetics website for six months following the event.
Important Safety Information
MYQORZO carries significant safety warnings. Patients must undergo regular assessments to monitor for heart failure risks associated with systolic dysfunction. Contraindications include use with rifampin and patients should be aware of arrhythmia risks.