STAT+: Cytokinetics details trial win for what could be its next approval

The company’s drug aficamten hit both its endpoints in a study in a condition known as nHCM Adobe Andrew covers the biopharma industry, scientific research, and public health across the continent. You can reach Andrew confidentially on Signal at drewqjoseph.71. It took Cytokinetics 27 years to win its first regulatory approval. The second one could happen much faster than that. The biotech on Friday unveiled the full pivotal study data of its drug aficamten in an inherited heart condition called non-obstructive hypertrophic cardiomyopathy, showing that the medicine improved how patients felt and their exercise capacity. While some experts have described the benefits as limited, Cytokinetics plans to submit the drug to the Food and Drug Administration by the end of the year. If approved, it would be the first treatment specifically cleared for what’s known as nHCM. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe Andrew covers the biopharma industry, scientific research, and public health across the continent. You can reach Andrew confidentially on Signal at drewqjoseph.71.