Edgewise Therapeutics Inc

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 has launched its first commercial drug, Myqorzo, in the United States and Germany following FDA and European Commission approvals for symptomatic obstructive hypertrophic cardiomyopathy. The U.S. rollout began in January 2026, with over 275 healthcare providers prescribing the drug and approximately 680 patients receiving it by the end of the first quarter, more than 70% of whom transitioned to paid prescriptions. The European Commission approved Myqorzo in February 2026, and the first EU launch occurred in Germany. The FDA has accepted a supplemental new drug application for Myqorzo as monotherapy, with a target action date of November 14, 2026, while the phase III ACACIA-HCM study in non-obstructive hypertrophic cardiomyopathy met both co-primary endpoints. Myqorzo competes with Bristol Myers Squibb's Camzyos and faces potential future competition from Edgewise Therapeutics' EDG-7500 and EDG-15400. Cytokinetics shares have gained 35.5% year to date, and the Zacks Consensus Estimate for 2026 loss per share has narrowed to $6.22.