Cytokinetics IncPresents positive aficamten data and plans sNDA for nHCM, expanding market.
Cytokinetics announced additional results from its ACACIA-HCM and MAPLE-HCM studies at the European Society of Cardiology Congress 2026, showing that aficamten improves cardiac structure and diastolic function in non-obstructive HCM and outperforms metoprolol across pre-trial treatment groups in obstructive HCM. The company plans to submit a supplemental new drug application for aficamten in nHCM in the fourth quarter of 2026, potentially expanding its market beyond the approved oHCM indication under the brand name Myqorzo. The FDA has already accepted Cytokinetics' sNDA for MAPLE-HCM, with a target action date of November 14, 2026. Myqorzo faces competition from Bristol Myers Squibb's Camzyos and Edgewise Therapeutics' EDG-7500, which is entering phase III in late 2026. Cytokinetics shares have gained 12.4% year to date, and the Zacks Consensus Estimate for 2026 loss per share has narrowed to $6 from $6.26 over the past 60 days.
Cytokinetics IncPresents positive aficamten data and plans sNDA for nHCM, expanding market.
Bristol-Myers Squibb CompanyCytokinetics' aficamten data may increase competition for Camzyos.
Edgewise Therapeutics IncCytokinetics' progress could pressure Edgewise's EDG-7500.