Less than two weeks later, the company decided to shut down the trial due to the low probability of success (due to safety concerns). This was a decision endorsed by the data monitoring committee that oversaw the trial. It was later announced that the FDA is also continuing to look into these blood clot incidences.

Because of this, the market seems to believe that the FDA will not approve Iclusig for any new indications. This makes the funding of additional clinical trials both expensive and potentially wasteful for Ariad Pharma, especially since the company is commercializing Iclusig.

This was clearly disappointing to investors who were hoping that the drug would soon see an enormous expansion of its label. Had it been successful, it would have been potentially used in thousands (instead of hundreds) of patients with blood cancer.

Note that the drug has already been brought to market on an accelerated approval pathway for treatment of resistant or intolerant chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia. The cardiovascular concerns were already seen in previous trials, so it carries a black box warning for cardiovascular risk. Nonetheless, the recent discoveries imply that Iclusig is far more dangerous than expected, which makes it much more difficult to use in CML patients who have not exhausted all of their options.

Investors are now attempting to value the company given its current prospects in CML. The stock yet to establish a solid “floor” at this point, and  serves as a reminder of the incredible risks that lone-drug biotech investors take – even with companies that have already received FDA approval.

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