Cytokinetics says FDA does not plan advisory committee meeting for aficamten NDA

In a regulatory filing, Cytokinetics (CYTK) disclosed that at upcoming investor conferences, the company will be providing, and is hereby furnishing, a brief regulatory update regarding its new drug application for aficamten. “During these investor conferences, representatives of the company will make statements consistent with the following: Cytokinetics has completed its midcycle review with the Food and Drug Administration with respect to the New Drug Application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy; FDA has informed Cytokinetics that it does not plan to convene an advisory committee meeting to review the company’s NDA for aficamten; We expect the Late Cycle meeting with FDA to occur in June 2025; We maintain our expectation for a differentiated label and risk mitigation profile for aficamten, if approved by FDA. As previously stated, the company does not plan to share detailed updates on its communications with the FDA,” the filing stated.