02:14 PM EDT, 05/02/2025 (MT Newswires) -- Cytokinetics ( CYTK ) shares fell 13% in recent Friday trading, a day after the US Food and Drug Administration extended the Prescription Drug User Fee Act action date to Dec. 26 for the new drug application for aficamten, a treatment for obstructive hypertrophic cardiomyopathy.

The agency needs more time to review the proposed risk evaluation and mitigation strategy fully, the company said Thursday in a statement.

The regulator determined that the submission of the REMS is a major amendment to the NDA, prompting a standard three-month extension to the original action date, the company said.

The FDA hasn't requested more clinical data or studies, Cytokinetics ( CYTK ) said.

Price: 37.47, Change: -5.45, Percent Change: -12.70