Cytokinetics (CYTK. O) announced in December 2023 that its experimental heart disease drug, aficamten, met the main goal of a closely watched late-stage study. This positive outcome sent the company’s shares soaring more than 80% to touch a more than 19-year high of $83.82.
The study, known as SEQUOIA-HCM, evaluated the efficacy and safety of aficamten in patients with obstructive hypertrophic cardiomyopathy (HCM), a genetic disorder that causes the heart muscle to thicken excessively, leading to reduced heart function and an increased risk of sudden cardiac death.
The results showed that aficamten significantly improved patients’ exercise capacity, their ability to perform physical activity, compared to placebo after 24 weeks of treatment. Additionally, the drug demonstrated favorable safety and tolerability profiles.
This positive data is a significant step forward for aficamten as it potentially provides a new treatment option for HCM patients. Analysts have called the results a “home-run” and said the drug compares favorably to Bristol Myers Squibb’s (BMY. N) Camzyos, the only approved drug for HCM in the United States.
Cytokinetics is now planning to seek marketing approval for aficamten in the United States and Europe in the second half of 2024. If approved, the drug could have a significant impact on the lives of HCM patients, potentially improving their quality of life and reducing their risk of sudden cardiac death.