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January 17, 2014
09:01 EDTSGENSeattle Genetics announces ADCETRIS approval in Japan
Seattle Genetics announced that its collaborator, Takeda Pharmaceutical Company Limited, has received approval of ADCETRIS from the Japanese Ministry of Health, Labour and Welfare for the treatment of patients with CD30-positive relapsed or refractory Hodgkin lymphoma and anaplastic large cell lymphoma. As a result, Seattle Genetics will receive two milestone payments from Takeda totaling $9M upon final pricing agreement in Japan. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL and known to be expressed in some types of non-Hodgkin lymphoma, including ALCL. The approval of the new drug application was based on two global pivotal phase 2 clinical trials of ADCETRIS, as well as a phase 1/2 clinical trial conducted in Japan, for patients with relapsed or refractory CD30-positive HL and ALCL. In March 2012, the Japanese MHLW granted ADCETRIS orphan drug designation for the treatment of patients with HL and ALCL, which triggered priority review in Japan.
News For SGEN From The Last 14 Days
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September 30, 2014
12:32 EDTSGENAnalysts differ on Seattle Genetics outlook after data
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10:02 EDTSGENOn The Fly: Analyst Downgrade Summary
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09:10 EDTSGENOn The Fly: Pre-market Movers
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08:18 EDTSGENSeattle Genetics downgraded at BofA/Merrill
As previously reported, BofA/Merrill downgraded Seattle Genetics to Underperform from Neutral. The firm said AETHERA data for interim overall survival advantage was not significant and could reinforce Adcetris' role as a salvage therapy as opposed to a frontline option. Price target lowered to $34 from $40.
07:43 EDTSGENSeattle Genetics outlook still positive, says RBC Capital
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06:16 EDTSGENSeattle Genetics downgraded to Underperform from Neutral at BofA/Merrill
September 29, 2014
13:07 EDTSGENSeattle Genetics weakness a buying opportunity, says Credit Suisse
Credit Suisse said Seattle Genetics top-line AETHERA data was significantly positive for the primary endpoint and expects full results in December at ASH to provide a meaningful update. The firm would use weakness as a buying opportunity and reiterates its Outperform rating and $51 price target.
12:59 EDTSGENSeattle Genetics positive data largely as expected, says Piper Jaffray
Piper Jaffray says the Seattle Genetics' positive top-line data from the Phase III ATHERA trial of ADCETRIS for consolidation therapy in high risk Hodgkin's lymphoma patients following stem cell transplant was largely as expected. Piper sees the potential for label expansion, but keeps an Underweight rating on the stock with a $26 price target.
06:49 EDTSGENSeattle Genetics, Takeda announce positive data from Phase 3 trial of Adcetris
Seattle Genetics and Takeda Pharmaceutical announced that patients with Hodgkin lymphoma who received ADCETRIS as consolidation therapy immediately following an autologous stem cell transplantation lived significantly longer without disease progression compared to patients who received placebo. The phase 3 clinical trial, known as AETHERA, compared the use of single agent ADCETRIS to placebo in 329 patients with HL who were at risk of relapse. ADCETRIS is an antibody-drug conjugate directed to CD30, a defining marker of classical HL. The AETHERA trial met its primary endpoint with ADCETRIS treatment resulting in a statistically significant improvement in progression-free survival versus placebo as assessed by an independent central review committee, which equates to a 75% improvement in PFS. PFS was assessed after a minimum of two years post initiation of treatment for all study patients. A pre-specified interim analysis of overall survival showed no statistically significant difference between the treatment arms. Patients on both study arms with progression of HL received a variety of subsequent therapies. Notably, most patients on the placebo arm received ADCETRIS after progression. A further analysis of overall survival is planned in 2016.
05:47 EDTSGENSeattle Genetics to host conference call
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September 26, 2014
17:59 EDTSGENSeattle Genetics up nearly 4% after hours after setting date for ADCETRIS data
September 24, 2014
09:07 EDTSGENSeattle Genetics reports additional data from Phase 1 trial of ADCETRIS
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