Ionis slips as FDA places clinical hold on ATTR trial

Ionis Pharmaceuticals Inc. (NASDAQ:IONS) lost $5.13 (11%) to $41.40 on Thursday after it said FDA placed a clinical hold on the planned Phase III CARDIO-TTR trial of IONIS-TTRRx to treat the familial amyloid cardiomyopathy (FAC) form of transthyretin (TTR)-mediated amyloidosis (ATTR). The therapy is a TTR antisense inhibitor.

According to Ionis, the agency is questioning partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) about CARDIO-TTR's protocol. The questions stem from the ongoing Phase III NEURO-TTR trial of IONIS-TTRRx to treat familial amyloidotic polyneuropathy (FAP), another form of ATTR. ...