Cytokinetics (NASDAQ:CYTK) shares jumped 31% after the company released positive results from its MAPLE-HCM trial, which compared its experimental heart medication aficamten with the standard beta blocker metoprolol for treating obstructive hypertrophic cardiomyopathy (oHCM).
The late-stage trial showed that aficamten led to improvements in cardiac structure and function versus metoprolol. The results were published in the Journal of the American College of Cardiology, while a separate analysis in Heart Rhythm reported an annual atrial fibrillation rate of just 1.5% with aficamten, in line with predictive models for hypertrophic cardiomyopathy (HCM) patients.
Wall Street analysts responded enthusiastically. Needham’s Serge Belanger called the trial a “clear win” for aficamten over metoprolol in both efficacy and safety, highlighting that aficamten outperformed on six of seven key endpoints, which he described as “likely better than expected.”
Citi analyst David Lebowitz noted that while it may take time for aficamten to surpass beta blockers in new-to-therapy patients, “we believe MAPLE could initiate a shift in the HCM treatment paradigm.”
Cantor’s Carter Gould added that the MAPLE results “matched, if not exceeded, investors’ high expectations, driven by the consistency of improvement with aficamten and the lack of any improvement with metoprolol.” He also emphasized that the findings were not only practice-changing but also differentiated aficamten from Bristol Myers’ Camzyos.
Although the MAPLE-HCM trial is not mandatory for FDA approval—expected on December 26—the data will support a supplemental new drug application. Cytokinetics hosted an investor webcast to discuss the results in detail.
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