Cytokinetics has reached a defining milestone after the U.S. Food and Drug Administration approved its heart drug Myqorzo for adults with obstructive hypertrophic cardiomyopathy, marking the first FDA clearance in the company’s 27-year history and positioning it directly against Bristol Myers Squibb’s Camzyos. The Cytokinetics Myqorzo FDA approval introduces a second cardiac myosin inhibitor into the market for the inherited condition, which limits the heart’s ability to pump blood, and clears the drug to improve functional capacity and symptoms in patients classified as New York Heart Association Class II or Class III. According to the company, Myqorzo will become commercially available in the second half of January, establishing Cytokinetics as a new entrant in a therapeutic area that has so far been dominated by a single branded option.
The Cytokinetics Myqorzo approval follows a period of volatility for the biotech, which was founded in 1997 and has only now brought its first product to market. The company faced setbacks when a late-stage ALS program failed and another cardiovascular therapy was rejected by regulators, but Myqorzo’s progress reshaped its development outlook. Like Camzyos, Myqorzo is a cardiac myosin inhibitor that works by relaxing heart muscle contraction to improve cardiac function, and both drugs are approved for the obstructive form of hypertrophic cardiomyopathy. But differences in how the therapies are prescribed could influence how the market develops. Myqorzo carries a heart failure warning similar to Camzyos, while its risk mitigation requirements are less restrictive. RBC Capital Markets analyst Leonid Timashev wrote that Myqorzo’s protocol allows more flexible dose adjustments, less frequent echocardiograms, and minimal drug-interaction monitoring, factors he said “should materially lower barriers to prescribing” compared with Camzyos.
Despite the significance of the Cytokinetics Myqorzo approval, investor reaction was muted, with analysts noting that labeling outcomes largely matched expectations. Stifel analyst James Condulis said there remains “debate” around the “extent” of Myqorzo’s differentiation from Camzyos, even as attention turns to upcoming clinical data. Cytokinetics is expected to report results from a study evaluating Myqorzo in patients with the non-obstructive form of hypertrophic cardiomyopathy, a setting in which Camzyos failed in a Phase 3 trial. Some analysts believe Myqorzo’s broader therapeutic dosing range could offer an advantage, though outcomes remain to be seen. “We’re bullish and expect [Myqorzo] to become the best [and] only drug for the entire HCM spectrum,” Condulis wrote.
Pricing for Myqorzo is expected to be “in line with” Camzyos, according to a company spokesperson, with details to be disclosed ahead of launch. Camzyos entered the market with an annual wholesale acquisition cost of $89,500. Myqorzo has also received regulatory clearance in China, extending its geographic footprint beyond the U.S. market. As Cytokinetics transitions from a development-stage biotech to a commercial drug company, the Cytokinetics Myqorzo FDA approval represents a pivotal step in establishing a long-term presence in cardiovascular therapeutics.
