Omecamtiv move shines the light on Amgen’s sparse pipeline

It is not often that the mere continuation of a trial sends a company’s share price soaring. But this happened yesterday, with Cytokinetics jumping 19% on news that the Galactic-HF study of its Amgen-partnered heart failure project, omecamtiv mecarbil, would carry on. A bigger surprise is that the asset is one of Amgen’s top pipeline contenders, according to consensus forecasts from EvaluatePharma. Amgen’s only bigger hope, excluding biosimilars, is the troubled osteoporosis project Evenity, which could finally be heading for US approval after a positive FDA panel vote in January, despite worries over side effects. Omecamtiv mecarbil could therefore become a new focus for Amgen, though it still has a lot to prove in a tricky indication. The Galactic-HF trial has passed a futility analysis designed to allow for a halt in the event of a low likelihood of benefit on the primary endpoint, time to cardiovascular death or first heart failure event. The study should enrol its full quota of 8,000 patients with heart failure with reduced ejection fraction in the first half of 2019. Subjects are receiving omecamtiv mecarbil plus standard of care versus standard of care alone; data should come in 2021.