Shares of Seattle Genetics (SGEN), a biotechnology company focused on the development and commercialization of therapies for the treatment of cancer, are in focus in morning trading after the company said that the U.S. Food and Drug Administration lifted a clinical hold on several early stage studies testing its experimental cancer drug.

CLINICAL HOLD LIFT: Seattle Genetics announced this morning that the FDA has lifted the clinical hold on phase 1 trials of vadastuximab talirine in acute myeloid leukemia. The clinical hold was announced on December 27 after the company reported the deaths of four people in trials testing the experimental cancer drug. Seattle Genetics said this morning that the clinical hold was resolved through a comprehensive study evaluating more than 300 patients and amendments to further enhance safety. The company said it would resume two Phase 1 trials in AML and and initiate a randomized Phase 2 trial of vadastuximab talirine in 2017 in patients with acute myeloid leukemia. The drug will continue to be tested in an ongoing Phse 3 trial in older AML patients as well as a Phase 1/2 trial in frontline high-risk myelodysplastic syndrome, the company said.

WHAT’S NOTABLE: In February, Seattle Genetics announced a development and licensing deal worth up to $2B with Immunomedics (IMMU) for IMMU-132, an experimental cancer drug, in a move to strengthen its cancer drug pipeline. The drug is currently in an early stage study in advanced breast cancer patients whose disease has progressed despite multiple therapies and has received the FDA’s “breakthrough status.” Seattle Genetics will develop, fund, manufacture and commercialize IMMU-132 under the terms of the deal.

ANALYST COMMENTARY: Piper Jaffray analyst Edward Tenthoff this morning reiterated his Neutral rating and $57 price target on Seattle Genetics. In a note to clients, Tenthoff noted that the FDA has lifted the partial clinical hold on two Phase I combination studies of vadastuximab talirine in AML but did not remove its full clinical hold on the Phase I/II SGN-CD33A monotherapy study in pre- and post-allogeneic stem cell transplant AML patients and that the company will terminate this study. Tenthoff expects an sBLA for Adcetris in cutaneous T-Cell Lymphoma mid-year and sees ECHELON-1 data in front-line Hodgkin lymphoma this year. Tentoff also said Seattle Genetics’ management guided for slower Adcetris sales growth this year, of 5%-13%, and he now sees $300M, at the high end of that range.

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