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Ariad hopes for a change of heart from the FDA Ariad Pharmaceuticals (NASDAQ: ARIA ) is trying to convince the FDA that its blood cancer drug, Iclusig, should be allowed back on the market after being pulled due to excessive risk of blood clotting. The drug is still on the market in Europe, however, after the European Medicines Agency, or EMA, put forth a set of guidelines for the drug's use. Ariad is hoping for a similar decision from the FDA next year.
My take is that the best Ariad can hope for is that Iclusig is allowed back on the market as a therapy of last resort. The FDA pulled the drug for safety concerns, and it's unlikely to do a complete about face. And now the EMA is also indicating it needs to further assess the drug's safety profile, which is unwelcome news for Ariad investors. So it's looking like the EMA is more likely to have a change of heart than the FDA.
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