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Seattle Genetics (SGEN): FDA Lifts Hold on Trial of AML Drug

Zacks Equity Research

Seattle Genetics, Inc. SGEN announced that the FDA has lifted the clinical hold on two phase I trials of its candidate, vadastuximab talirine (SGN-CD33A; 33A).  

Vadastuximab talirine is an early stage candidate that is being developed for the treatment of acute myeloid leukemia (AML).

The partial clinical hold was implemented in Dec 2016 to evaluate the potential risk of liver toxicity in patients treated with vadastuximab talirine, who underwent a stem cell transplant either before or after the treatment.

Seattle Genetics outperformed the Zacks classified Medical-Biomedical/Genetics industry year to date. The stock jumped almost 27.1% during this period while the industry gained 6.9%.

The clinical hold on vadastuximab talirine was resolved through an analysis of the clinical data from over 300 patients treated to date and evaluated by an independent committee of clinical experts, collaborative interactions with the FDA and protocol amendments designed to further enhance patient safety.

Consequently, Seattle Genetics will resume two phase I trials of vadastuximab talirine. The first trial will be a combination treatment with standard of care, or 7+3, chemotherapy in newly diagnosed younger AML patients. The second is monotherapy and combination treatment with hypomethylating agents in both newly diagnosed and relapsed AML patients.

Meanwhile, the company continues to enroll patients in the phase III CASCADE study in frontline older AML patients and in a phase I/II study in frontline high-risk myelodysplastic syndrome (MDS).

Seattle Genetics, Inc. Price

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Zacks Rank & Key Picks

Seattle Genetics currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked stocks in the health care sector include Heska Corp. HSKA, Sunesis Pharmaceuticals SNSS and Celgene Corp. CELG. While Heska sports a Zacks Rank#1 (Strong Buy), Sunesis Sciences and Celgene carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here

Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 291.54%.

Sunesis’ loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 30 days. The company recorded positive earnings surprises in three of the last four quarters, the average being 0.54%.

Celgene’s earnings estimates increased from $6.52 to $6.60 for 2017 and from $8.15 to $8.16 for 2018, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 5.08%.

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