Cytokinetics Announces FDA Approval of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms
12/19/2025 04:00 PM • Cytokinetics announced FDA approval of MYQORZO (aficamten), a cardiac myosin inhibitor for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The approval is based on the SEQUOIA-HCM Phase 3 trial, which demonstrated significant improvements in exercise capacity and symptom relief. The drug will be available in the U.S. in the second half of January 2026 and is subject to a REMS program due to heart failure risks. Cytokinetics also received NMPA approval in China and a positive opinion from the European Medicines Agency.
CYTK - Company achieved its first FDA approval for MYQORZO, a significant milestone. The drug demonstrated robust efficacy in clinical trials with meaningful improvements in exercise capacity and symptom relief. Additional regulatory approvals in China and positive opinion from EMA provide further validation and expansion opportunities. The approval represents a major achievement for the company's pipeline and future revenue potential.
Investing.com • Nathan Reiff