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Biotech Stocks Facing FDA Decision In December 2021

Calliditas Therapeutics
Calliditas Therapeutics

The FDA will decide whether or not to grant accelerated approval for Calliditas Therapeutics AB’s (CALT) Nefecon on December 15.

Nefecon is a proprietary, novel oral formulation of budesonide, an established, local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy.

IgA nephropathy, commonly known as Berger's disease, is a kidney disease caused by the build-up of an antibody called immunoglobulin A (IgA) in the kidneys.

If approved, Nefecon would become the first therapy specifically designed and approved for the treatment of IgA nephropathy.

Nefecon could achieve peak sales of $1 billion, according to analysts.

CALT closed Friday’s trading at $17.85, down 8.88%.