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Biotech Stocks Facing FDA Decision In August 2020

Roche
Roche

The FDA decision on Roche’s (RHHBY.OB) Satralizumab, proposed for the treatment of neuromyelitis optica spectrum disorder, is expected on August 30, 2020.

Neuromyelitis optica spectrum disorder (NMOSD) is a rare, autoimmune disease of the central nervous system that primarily attacks the optic nerves and spinal cord leading to blindness and paralysis. (Source: NCBI).

Satralizumab is a subcutaneously delivered humanized monoclonal antibody that targets the IL-6 receptor believed to play a key role in the inflammation that occurs in people with NMOSD.

There are two FDA-approved drugs for this rare disease - Alexion Pharma’s Soliris, greenlighted in June 2019, and Viela Bio’s Uplizna, approved in June of 2020.

Satralizumab is approved in Canada and Japan, under the brand name Enspryng.

RHHBY.OB closed Friday’s (Jul.24, 2020) trading at $42.95, down 2.45%.