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Biotech Stocks Facing FDA Decision In December 2022

Cytokinetics
Cytokinetics

A panel of federal advisers is scheduled to review Cytokinetics Inc.’s (CYTK) Omecamtiv Mecarbil on December 13, 2022.

Omecamtiv mecarbil is proposed for the treatment of heart failure with reduced ejection fraction (HFrEF). This compound stimulates cardiac myosin, a protein responsible for converting chemical energy into the mechanical force that results in contraction of the heart. It is designed to improve cardiac muscle performance, potentially helping patients preserve cardiac function and avoid hospitalizations.

More than two million people in the U.S. with HFrEF have signs and symptoms of worsening heart failure despite standard of care therapy, pointing to a clear unmet medical need for more treatment options, according to the company.

The FDA’s final decision is due on February 28, 2023. The regulatory agency usually follows the recommendations of its panels although it is not required to do so.

CYTK closed Friday’s trading at $40.68, up 0.42%.