Seattle Genetics stock tumbles after 4 deaths force the FDA to slap a clinical hold on AML drug
Seven months after Seattle Genetics $SGEN launched a registration study for an armed antibody dubbed SGN-CD33A (vadastuximab talirine), the FDA slapped a full or partial hold on a slate of its early-stage efforts in acute myeloid leukemia after four patients died of liver toxicity.
Seattle Genetics’ stock tumbled 15% on the news, wiping out more than a billion dollars in market cap.
The full hold was placed on a Phase I/II trial in pre- and post-allogeneic transplant AML patients while the FDA ordered new recruitment stopped for two Phase I studies. Researchers say that the tracked 6 cases of hepatotoxicity, or liver toxicity, including cases of veno-occlusive disease.
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