Today, shares of Seattle Genetics (SGEN) were halted in pre-market trade after the company announced that the FDA had placed multiple early stage-studies on clinical hold. The reason for the clinical hold on all these trials is due to 6 patients experiencing hepatotoxicity and at least four patients dying from treatment.
The drug in question is known as Vadastuximab talarine. This drug was being evaluated to treat patients with a type of blood cancer known as acute myeloid Leukemia or AML. The trial halt includes a phase 1/2 trial placed on full clinical hold, along with two other phase 1 trials placed on partial clinical hold.
This is not good news for the company at all because it puts a lot of trials in its pipeline on hold. In the meantime, SGEN must address this issue with the FDA. That could take a few weeks to a few months. The point is that it puts a stop to these trials until everything can be cleared up in time. This will definitely hurt the stock which is down 14.55% pre-market. Until this issue clears up the stock should continue to see further sell pressure in the coming days.
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