CRL sends Akcea and Ionis on downward spiral

Shares in Californian company Ionis Pharmaceuticals (Nasdaq: IONS) opened 12% down on Tuesday.

A major reason for the sharp decline was the Complete Response Letter (CRL) received from the US Food and Drug Administration (FDA) by Ionis’ sister company, Akcea Therapeutics (Nasdaq: AKCA), which itself opened 28% lower. Akcea is seeking approval of Waylivra (volanesorsen) for familial chylomicronemia syndrome (FCS), a rare lipid disorder with no therapeutic options.

Receiving the CRL means Akcea now faces a roadblock in its development of a drug that an FDA panel raised safety concerns over, despite voting in favor of approval during a May meeting.