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Seattle Genetics (SGEN) Submits BLA to FDA for Cancer Drug
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Seattle Genetics, Inc. announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).
In fact, Adcetris is the only marketed product at Seattle Genetics. The drug is approved for relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma (sALCL) in the U.S., the EU and Japan. It is also approved in the U.S. for the treatment of patients suffering from classical Hodgkin lymphoma who are at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Notably, Seattle Genetics outperformed the Zacks classified Medical-Biomedical/Genetics industry year to date. The stock jumped almost 17.8%, while the industry gained 6.4%.
The submission of the supplemental BLA was mainly based on positive data from the phase III trial, ALCANZA in patients with CTCL. We note that the ALCANZA study achieved both the primary and secondary endpoints. The study showed that CTCL patients treated with Adcetris had superior outcomes across all primary and secondary endpoints compared with patients in the control arm, who were treated with either methotrexate or bexarotene standard of care agents.
We remind investors that the FDA granted Breakthrough Therapy Designation (BTD) to Adcetris for the treatment of patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma. who require systemic therapy and have received one prior systemic therapy in Nov 2016.
In fact, Adcetris generated revenues of $70.3 million in the first quarter of 2017, up 20% year over year and is expected to generate sale in the range of $280–$300 million in the U.S. and Canada in 2017. Seattle Genetics is also working on expanding the drug’s label which will be a further boost for the company’s revenues.
Recently, Seattle Genetics announced that it will discontinue the phase III study, CASCADE of its pipeline candidate vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia (AML) patients. This is a setback for the company. Thus label expansion of its only marketed drug Adcetris plays an important role in the growth of the company’s revenues.
Seattle Genetics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include VIVUS, Inc. , MEI Pharma, Inc. (MEIP - Free Report) and Sanofi (SNY - Free Report) . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company delivered positive earnings surprises in all four trailing quarters, with an average beat of 233.69%.
MEI Pharma’s estimates moved up from loss per share of 1 cent to gain per share of the same for 2017, over the last 60 days. The company came up with positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%. The share price of the company has increased 45.1% year to date.
Sanofi’s earnings per share estimates increased from $3.26 to $3.30 for 2018, over last 30 days. The company pulled off positive earnings surprises in three of four trailing quarters, with an average beat of 5.10%.
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Seattle Genetics (SGEN) Submits BLA to FDA for Cancer Drug
Seattle Genetics, Inc. announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL).
In fact, Adcetris is the only marketed product at Seattle Genetics. The drug is approved for relapsed Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma (sALCL) in the U.S., the EU and Japan. It is also approved in the U.S. for the treatment of patients suffering from classical Hodgkin lymphoma who are at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Notably, Seattle Genetics outperformed the Zacks classified Medical-Biomedical/Genetics industry year to date. The stock jumped almost 17.8%, while the industry gained 6.4%.
The submission of the supplemental BLA was mainly based on positive data from the phase III trial, ALCANZA in patients with CTCL. We note that the ALCANZA study achieved both the primary and secondary endpoints. The study showed that CTCL patients treated with Adcetris had superior outcomes across all primary and secondary endpoints compared with patients in the control arm, who were treated with either methotrexate or bexarotene standard of care agents.
We remind investors that the FDA granted Breakthrough Therapy Designation (BTD) to Adcetris for the treatment of patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma. who require systemic therapy and have received one prior systemic therapy in Nov 2016.
In fact, Adcetris generated revenues of $70.3 million in the first quarter of 2017, up 20% year over year and is expected to generate sale in the range of $280–$300 million in the U.S. and Canada in 2017. Seattle Genetics is also working on expanding the drug’s label which will be a further boost for the company’s revenues.
Recently, Seattle Genetics announced that it will discontinue the phase III study, CASCADE of its pipeline candidate vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia (AML) patients. This is a setback for the company. Thus label expansion of its only marketed drug Adcetris plays an important role in the growth of the company’s revenues.
Seattle Genetics, Inc. Price and Consensus
Seattle Genetics, Inc. Price and Consensus | Seattle Genetics, Inc. Quote
Zacks Rank & Stocks to Consider
Seattle Genetics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include VIVUS, Inc. , MEI Pharma, Inc. (MEIP - Free Report) and Sanofi (SNY - Free Report) . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company delivered positive earnings surprises in all four trailing quarters, with an average beat of 233.69%.
MEI Pharma’s estimates moved up from loss per share of 1 cent to gain per share of the same for 2017, over the last 60 days. The company came up with positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%. The share price of the company has increased 45.1% year to date.
Sanofi’s earnings per share estimates increased from $3.26 to $3.30 for 2018, over last 30 days. The company pulled off positive earnings surprises in three of four trailing quarters, with an average beat of 5.10%.
Zacks' Hidden Trades
While we share many recommendations and ideas with the public, certain moves are hidden from everyone but selected members of our portfolio services. Would you like to peek behind the curtain today and view them?
Starting now, for the next month, I invite you to follow all Zacks' private buys and sells in real time from value to momentum...from stocks under $10 to ETF to option movers...from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors. Click here for Zacks' secret trade>>