FDA Delays Aficamten Approval Review to December 26

The FDA has delayed its decision on Cytokinetics' heart drug aficamten for obstructive hypertrophic cardiomyopathy, extending the review period by three months to December 26 after requesting a Risk Evaluation and Mitigation Strategy (REMS) plan. Cytokinetics initially submitted its application without a REMS, but the FDA later determined the plan was necessary due to the drug’s characteristics. No additional clinical data or studies have been requested, and the delay is viewed as a standard procedural extension rather than a negative indicator for approval. The announcement triggered a double-digit drop in Cytokinetics’ share price, reflecting short-term investor uncertainty. However, most analysts remain optimistic about aficamten’s prospects and believe the extension does not diminish the drug's approval chances. The company and analysts anticipate a differentiated label and REMS for aficamten compared to existing treatments.