On Apr 10, we issued an updated research report on Seattle Genetics, Inc. (SGEN - Free Report) . The company’s top line mainly comprises product revenues, collaboration and license agreement revenues plus royalties.
Seattle Genetics’ only marketed product is Adcetris (brentuximab vedotin). The drug is approved for relapsed Hodgkin lymphoma (HL) and relapsed systemic anaplastic large cell lymphoma (sALCL) in the United States, the EU and Japan.
Adcetris is also approved in the United States and Europe for the treatment of patients suffering classical Hodgkin lymphoma (cHL) with no prior treatment and who are also at high risk of relapse or progression post autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. It is also approved for primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) in the United States.
Notably, in February 2019, Seattle Genetics announced that its Japanese partner, Takeda Pharmaceutical Company Limited, received a nod from the European Commission (EC) to extend the marketing authorization for Adcetris to include the combination of the drug and AVD (Adriamycin, vinblastine and dacarbazine) for treating adult patients with previously untreated CD30+ stage IV cHL.
Adcetris in combination with AVD is also approved in the United States for the treatment of adult patients with the earlier untreated stage III or IV cHL.
Seattle Genetics has an agreement with Takeda for the development and commercialization of Adcetris. The company retains all its rights to sell Adcetris in the United States and Canada while Takeda has the commercial rights to the drug in the rest of the world.
However, Adcetris has several competitors including Bristol-Myers Squibb’s (BMY - Free Report) Opdivo and Merck’s (MRK - Free Report) Keytruda, which are approved for relapsed or refractory cHL.
Shares of Seattle Genetics have surged 42.8% so far this year, outperforming the industry’s increase of 9.8%.
Apart from Adcetris, Seattle Genetics has some promising pipeline candidates in its portfolio, which are under early- and mid-stage development.
Seattle Genetics and Astellas are evaluating enfortumab vedotin in a pivotal phase II study on patients with metastatic urothelial cancer, previously treated with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy. In March 2019, both companies reported positive top-line results from the first cohort of the phase II EV-201 program on enfortumab vedotin. Both entities plan to submit a biologics license application (BLA) for enfortumab vedotin to the FDA later this year.
Also, during the same month, Seattle Genetics completed enrollment in the phase II innovaTV 204 probe on tisotumab vedotin, currently under evaluation as a monotherapy for treating patients with advanced/metastatic cervical cancer, whose disease relapsed or progressed after the standard of care treatment. Tisotumab vedotin is being developed in partnership with the Danish company, Genmab A/S (GNMSF - Free Report) .
Another interesting candidate in Seattle Genetics’ portfolio is SEA-BCMA, which is being assessed in a phase I investigation for treating patients with relapsed or refractory multiple myeloma (MM).
Adcetris is performing well since its launch and the drug’s label expansion programs look promising as well. However, Seattle Genetics remains heavily dependent on Adcetris for revenues, which is a matter of concern. Therefore, a decline in the medicine’s sales will adversely impact the company's top line. Although the organization is working on various label expansion studies of the drug, any unfavorable response from the regulatory bodies could materially hurt the stock.
Seattle Genetics, Inc. Price and Consensus
Seattle Genetics currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strrong Buy) stocks here.
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