Myqorzo (Aficamten) Receives Initial FDA Approval as New Molecular Entity

The U.S. Food and Drug Administration (FDA) granted initial approval to Myqorzo (aficamten) on 2025-12-19. This approval designates Myqorzo as a Type 1 - New Molecular Entity, marking its first entry into the market.

Background

Myqorzo (aficamten) is classified as a Type 1 - New Molecular Entity, indicating it is an active ingredient that has not been previously approved by the FDA. The sponsor for this newly approved drug is CYTOKINETICS.

What this means

The initial FDA approval of Myqorzo (aficamten) as a New Molecular Entity introduces a new therapeutic agent. This milestone makes aficamten available for clinical use following its regulatory clearance.

Source

The information regarding this approval was obtained from the U.S. Food and Drug Administration (FDA) website. The approval for New Drug Application (NDA) 219083 was posted on 2025-12-19 on accessdata.fda.gov.