The FDA approved Cytokinetics’ Myqorzo, giving the company its first U.S. drug authorization after a 27-year run. Regulators cleared the therapy to treat obstructive hypertrophic cardiomyopathy (HCM), positioning Cytokinetics to compete with an existing Bristol Myers Squibb agent already generating more than $1 billion annually. Company guidance indicates Myqorzo will launch commercially in late January; pricing and market-share dynamics versus the incumbent will shape near-term revenue and partnership discussions. Approval follows decades of R&D and late-stage data that satisfied FDA efficacy and safety thresholds for a rare genetic heart disorder. The clearance removes a major commercialization milestone risk for Cytokinetics and creates a direct head-to-head commercial contest with BMS in a high-value specialty cardiology niche.