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Seattle Genetics' Acute Myeloid Leukemia Drug on FDA Hold

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Shares of Seattle Genetics, Inc.SGEN plunged 15.4% after the FDA placed a full clinical hold on a phase I/II study and a partial clinical hold on two phase I studies on vadastuximab talirine (SGN-CD33A) following the death of four patients.

Note that Seattle Genetics' year-to-date share price movement shows that the company has outperformed the Zacks classified Medical-Biomedical/Genetics industry. Specifically, the stock surged almost 60% during this period, while the industry lost 0.4%.

SGN-CD33A is being developed for the treatment of patients with acute myeloid leukemia (AML).

The partial clinical hold was implemented to evaluate the potential risk of liver toxicity in patients treated with the candidate, who underwent a stem cell transplant either before or after the treatment.

Until the clinical holds are lifted, no new study on the candidate can be initiated.

In its press release, the company mentioned that it is currently working with the FDA to determine if there is any association between hepatotoxicity and treatment with SGN-CD33A, and to identify appropriate protocol amendments for patient safety and aid continuation of the studies.

Meanwhile, the company continues to enroll patients in the phase III CASCADE study in older AML patients and in a phase I/II study in myelodysplastic syndrome.

Considering that Adcetris is the only approved product in Seattle Genetics' portfolio, clinical hold on as many as three early-stage studies on SGN-CD33A is disappointing. A successful development of pipeline candidates is essential for the company to reduce its dependence on Adcetris.

SEATTLE GENETIC Price and Consensus

SEATTLE GENETIC Price and Consensus | SEATTLE GENETIC Quote

Seattle Genetics currently carries a Zacks Rank #3 (Hold).

Key Picks in the Sector

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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