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Biotech Stocks Facing FDA Decision In August

Akcea Therapeutics
Akcea Therapeutics

The FDA is scheduled to announce its final decision on Akcea Therapeutics Inc.’s (AKCA) Volanesorsen, proposed for the treatment of a rare lipid disorder called familial chylomicronemia syndrome (FCS), on August 30, 2018.

Volanesorsen is co-developed by Akcea and Ionis Pharmaceuticals Inc. (IONS).

In May of this year, an FDA panel had voted 12-8 to recommend the approval of Volanesorsen. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

Currently, there are no approved therapies for the treatment of FCS. If approved, Volanesorsen would be the first therapy indicated for FCS patients.

Jefferies' analyst Eun Yang has estimated peak sales of Volanesorsen at around $150 million.

AKCA closed Wednesday’s (Jul 25) trading at $32.99, up 2.36%.