Seattle Genetics' Adcetris Granted Priority Review By FDA
Zacks Investment Research | Aug 17, 2017 06:33AM ET
Seattle Genetics, Inc. (NASDAQ:SGEN) 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. (NASDAQ:ALXN) , Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi (NYSE:SNY) . While Alexion and Regeneron sport a Zacks Rank #1 (Strong Buy), Sanofi holds Zacks Rank #2 (Buy). You can see .
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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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