The FDA approved Cytokinetics’ Myqorzo, marking the company’s first U.S. drug approval for obstructive hypertrophic cardiomyopathy after a decades-long effort. Myqorzo will enter the market as a competitor to Bristol Myers Squibb’s established therapy, setting up an immediate commercial contest in a rare cardiac indication that already supports blockbuster-level sales for the incumbent. Cytokinetics plans to begin sales in late January; pricing was not disclosed at announcement. Industry coverage noted the approval completes a long development arc for Cytokinetics and could materially alter the company’s valuation and commercial strategy. The approval underscores persistent regulatory willingness to clear new drugs in specialized cardiology niches and will test the ability of a smaller biotech to commercialize against a large pharma incumbent.