FDA clinical hold on Iclusig sees Ariad stock go into free-fall

10 October 2013

US drugmaker Ariad Pharmaceuticals (Nasdaq: ARIA) saw its shares plunge 59% to $6.99 yesterday (October 9), wiping $2 billion off its market capitalization, when the company revealed that the Food and Drug Administration put a hold in clinical trial enrollment for its cancer drug Iclusig (ponatinib) as a result of blood clots in patients treated with the drug in ongoing studies of the already cleared for marketing drug.

Iclusig was approved by the FDA last year to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases (The Pharma Letter December 17, 2012).

Ariad announced results of its review of updated clinical data from the pivotal PACE trial of Iclusigand actions that it is taking following consultations with the FDA.

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