Aficamten

Aficamten, developed by Cytokinetics, is a cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (HCM), a condition causing thickened heart muscle and reduced cardiac function. FDA has accepted its NDA with a PDUFA target date of September 26, 2025, supported by Phase 3 trial SEQUOIA-HCM results showing improved exercise capacity. Previously granted Orphan Drug and Breakthrough Therapy Designations.

Cytokinetics halts ALS trial for resedemtiv after phase 3 COURAGE-ALS shows no benefit over placebo. Following FDA rejection of heart failure drug omecamtiv mecarbil, focus shifts to aficamten for HCM, with phase 3 SEQUOIA-HCM results awaited. Aficamten faces competition from BMS's Camzyos in the HCM market.

Cytokinetics awaits FDA decision on aficamten for obstructive HCM by September 2025, aiming to rival BMS's Camzyos. Aficamten shows promise with a competitive clinical profile, potentially becoming a $3 billion product. Both companies also target non-obstructive HCM, with Cytokinetics conducting MAPLE-HCM and ACACIA-HCM studies.

The FDA rejected Cytokinetics' omecamtiv mecarbil for heart failure due to insufficient efficacy data, despite a 8% reduction in cardiovascular death or heart failure events in the GALACTIC-HF study. Cytokinetics may focus on aficamten, another drug in phase 3 trials, after considering further discussions with the FDA.

Cytokinetics' New Drug Application for aficamten, targeting obstructive hypertrophic cardiomyopathy, accepted by FDA with a standard review and a target action date of September 26, 2025. No advisory committee meeting planned.

Cytokinetics granted stock options, RSUs, and PSUs to 9 new employees as employment inducements on December 31, 2024. The awards aim to attract talent, with vesting schedules encouraging long-term commitment and aligning with company performance goals. The initiative supports Cytokinetics' focus on cardiovascular disease treatments.

RTW Biotech Opportunities Ltd announced Corxel Pharmaceuticals Co Ltd's agreement with Sanofi SA for aficamten rights in Greater China and its acquisition of CX11 rights from Vincentage Pharma Co Ltd for obesity and diabetes treatment.

Corxel Pharmaceuticals acquired VCT220, a Phase 2-ready oral GLP-1 agonist for obesity and diabetes, from Vincentage Pharma, excluding Greater China. Renamed CX11, it aims to offer a patient-friendly alternative to injectable GLP-1 drugs, with Phase 3 trials underway in China and global Phase 2 trials planned for 2025.

Cytokinetics announced EMA validation of aficamten's MAA for obstructive HCM, supported by SEQUOIA-HCM trial results. The drug, a cardiac myosin inhibitor, aims to improve exercise capacity and relieve HCM symptoms.

Cytokinetics announces Sanofi's acquisition of aficamten rights in Greater China for HCM treatment. Aficamten, a selective cardiac myosin inhibitor, targets myocardial hypercontractility. Cytokinetics eligible for up to $150m in milestone payments and royalties on sales.