Seattle Genetics, Inc. announced that the FDA has accepted its supplemental Biologics License Application (BLA) for Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL). Additionally, the FDA granted Priority Review for the application and has set a target action date of Dec 16, 2017.
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, shares of the company have declined 11.4% against the Zacks classified industry’s gain of 7.4% on a year-to-date basis.
The submission of the supplemental BLA was mainly based on positive data from the phase III trial, ALCANZA and two phase II investigator-sponsored trials in patients with CTCL. Interestingly, 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.
Furthermore, 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 November 2016.
Adcetris, generated revenues of $74.3 million, up 12.3% year over year in the second quarter of 2017 and is expected to generate sale in the range of $290 million to $310 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.
Zacks Rank & Stocks to Consider
Seattle Genetics currently holds a Zacks Rank #3 (Hold). Some better-ranked stocks in health care sector include Alexion Pharmaceuticals, Inc. , Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Sanofi (SNY - Free Report) . While Alexion and Regeneron sport a Zacks Rank #1 (Strong Buy), Sanofi holds Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alexion Pharmaceuticals’ earnings per share estimates have moved up from $4.55 to $4.77 for 2017 and from $5.49 to $6.43 for 2018 over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 12.26%. The share price of the company has increased 11.7% year to date.
Regeneron’s earnings per share estimates have increased from $10.52 to $13.81 for 2017 and from $12.10 to $14.54 for 2018 over the last 30 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 6.29%. The share price of the company has increased 27.6% year to date.
Sanofi’s earnings per share estimates have moved up from $3.20 to $3.31 for 2017 and from $3.36 to $3.38 for 2018 over last 30 days. The company came up with positive earnings surprises in three of the trailing four quarters, with an average beat of 5.10%. The share price of the company has increased 19.7% year to date.
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Seattle Genetics, Inc. announced that the FDA has accepted its supplemental Biologics License Application (BLA) for Adcetris (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL). Additionally, the FDA granted Priority Review for the application and has set a target action date of Dec 16, 2017.
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, shares of the company have declined 11.4% against the Zacks classified industry’s gain of 7.4% on a year-to-date basis.
The submission of the supplemental BLA was mainly based on positive data from the phase III trial, ALCANZA and two phase II investigator-sponsored trials in patients with CTCL. Interestingly, 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.
Furthermore, 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 November 2016.
Adcetris, generated revenues of $74.3 million, up 12.3% year over year in the second quarter of 2017 and is expected to generate sale in the range of $290 million to $310 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.
Zacks Rank & Stocks to Consider
Seattle Genetics currently holds a Zacks Rank #3 (Hold). Some better-ranked stocks in health care sector include Alexion Pharmaceuticals, Inc. , Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Sanofi (SNY - Free Report) . While Alexion and Regeneron sport a Zacks Rank #1 (Strong Buy), Sanofi holds Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alexion Pharmaceuticals’ earnings per share estimates have moved up from $4.55 to $4.77 for 2017 and from $5.49 to $6.43 for 2018 over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 12.26%. The share price of the company has increased 11.7% year to date.
Regeneron’s earnings per share estimates have increased from $10.52 to $13.81 for 2017 and from $12.10 to $14.54 for 2018 over the last 30 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 6.29%. The share price of the company has increased 27.6% year to date.
Sanofi’s earnings per share estimates have moved up from $3.20 to $3.31 for 2017 and from $3.36 to $3.38 for 2018 over last 30 days. The company came up with positive earnings surprises in three of the trailing four quarters, with an average beat of 5.10%. The share price of the company has increased 19.7% year to date.
One Simple Trading Idea
Since 1988, the Zacks system has more than doubled the S&P 500 with an average gain of +25% per year. With compounding, rebalancing and exclusive of fees, it can turn thousands into millions of dollars. This proven stock-picking system is grounded on a single big idea that can be fortune shaping and life changing. You can apply it to your portfolio starting today. Learn more >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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