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Fly News Breaks for December 28, 2016
SGEN
Dec 28, 2016 | 07:11 EDT
Leerink analyst Michael Schmidt says the FDA has placed clinical holds on three ongoing early-stage trials of Seattle Genetics' vadastuximab talirine in acute myeloid leukemia, or AML, but notes the ongoing Phase 3 CASCADE trial in front-line AML and a Phase 1/2 study in Myelodysplastic syndrome were not affected. After speaking with the company's management, Schmidt points out that Seattle Genetics expects a "potential rapid resolution" of the partial clinical hold on two of the affected Phase 1/2 trials in AML, while the FDA seems focused on the ongoing pre-transplant conditioning study where the rate of hepatotoxicity is already high with standard of care chemotherapy alone. He reiterates an Outperform rating on the shares.
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