Aficamten scores in Phase III trial, after FDA decision delay

14 May 2025

US biotech Cytokinetics (Nasdaq: CYTK) has unveiled fresh Phase III data backing its heart drug aficamten, showing the treatment was more effective than the standard beta blocker metoprolol in patients with obstructive hypertrophic cardiomyopathy.

The announcement follows a recent and unexpected delay by the American medicines regulator, which pushed back a key approval decision on aficamten until late December.

The MAPLE-HCM trial met its main goal, with aficamten delivering a statistically significant improvement in patients’ peak exercise capacity compared to metoprolol over 24 weeks. Safety and tolerability also favored the experimental therapy.

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