Cytokinetics Stock Soars After Positive Phase 3 Data as FDA Approval Decision for Aficamten Nears

Cytokinetics awaits a U.S. FDA approval decision for aficamten, a next-generation cardiac myosin inhibitor for obstructive hypertrophic cardiomyopathy (oHCM), with the Prescription Drug User Fee Act (PDUFA) target action date set for December 26, 20251 2 3 4.

The FDA review was extended to December 2025 due to requirements to submit a Risk Evaluation and Mitigation Strategy (REMS), but there are no outstanding clinical data concerns3 4.

Phase 3 clinical trial (SEQUOIA-HCM) results underpinning the NDA showed aficamten significantly improved exercise capacity, symptom burden, and cardiac biomarkers, with a safety profile comparable to placebo and no reported heart failure cases1 3 5.

Aficamten outperformed metoprolol and has a differentiated pharmacokinetic and safety profile versus its main competitor, mavacamten, potentially positioning it as a preferred first-line oHCM therapy3 5.

Analysts project peak U.S. annual sales for aficamten between $800 million and $2 billion, and up to 113% stock upside for Cytokinetics if approval is granted2 3 4.

Cytokinetics possesses strong financial reserves (~$1B cash) and global partnerships, supporting commercialization efforts and reducing risk for investors2 3 4.

The stock has soared on positive clinical results and high conviction regarding the approval and commercial prospects of aficamten ahead of the FDA decision2 3 4.