After the company disclosed that the Food and Drug Administration has awarded fast-track status to its lead drug candidate, omecamtiv mecarbil, shares in Cytokinetics (NASDAQ:CYTK) are surging 24.5% higher at 12:00 pm EST on Monday.
Omecamtiv mecarbil is currently under evaluation by the biotech company in a large-scale phase 3 clinical trial, GALACTIC-HF, that's expected to have top-line results available in Q4, 2020. Since the treatment has the potential to help heart patients with reduced ejection fraction, the FDA awarded it a fast-track designation, which provides increased FDA guidance and a streamlined process of application for approval.
A cardiac myosin activator, omecamtiv mecarbil stimulates a heart muscle protein responsible for causing the heart to contract and pump blood, potentially resulting in better cardiac function. Its GALACTIC-HF phase 3 study, which is being conducted in conjunction with collaboration partner Amgen (NASDAQ:AMGN), is determining if adding the therapy to standard care can reduce the risk of future heart failure events and death in heart failure patients.
The trial has enrolled 8,256 patients in 35 countries who were hospitalized for the primary reason of heart failure or had a hospitalization or admission to an emergency room for heart failure within the past year.
The market potential for omecamtiv mecarbil is massive. Heart failure affects over 64 million people globally, and roughly half of those patients have reduced left ventricular function, suggesting they could benefit from the treatment. The number of heart patients is expected to climb as baby boomers get older, because approximately 20% of people over age 40 are at risk of developing heart failure. Because about 50% of heart failure patients pass away within five years of their initial hospitalization, there's significant need for new treatment options.
If the drug is approved, Cytokinetics can receive up to $600 million in clinical-stage and commercial milestones, plus royalties on sales. Additionally, an agreement in which Cytokinetics is paying $40 million in phase 3 development gave it an increased royalty payout and the potential to co-commercialize omecamtiv mecarbil in institutional care settings in North America. Separately, Servier has licensed exclusive rights to market the treatment in Europe.