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Biotech Stocks Facing FDA Decision In December 2021

Reata Pharmaceuticals
Reata Pharmaceuticals

Reata Pharmaceuticals Inc.’s (RETA) New Drug Application for Bardoxolone Methyl is scheduled to be reviewed by an FDA panel on December 8.

Bardoxolone Methyl is proposed for the treatment of patients with chronic kidney disease caused by Alport syndrome.

Alport syndrome is a rare, genetic form of chronic kidney disease caused by mutations in the genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney. Alport syndrome affects both children and adults.

The kidneys of patients with Alport syndrome progressively lose the capacity to filter waste products out of the blood, which can lead to end-stage kidney disease and the need for chronic dialysis treatment or a kidney transplant.

Approximately 30,000 to 60,000 Americans are affected with Alport Syndrome, and there is no approved treatment for this disease.

The final FDA decision on Bardoxolone Methyl is expected on February 25, 2022.

If approved, Bardoxolone Methyl has the potential to achieve blockbuster sales, according to analysts.

RETA closed Friday’s trading at $81.40, down 4.07%