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February 6, 2013
09:02 EDTSGENSeattle Genetics initiates two Phase I trials of SGN-CD19A
Seattle Genetics announced the initiation of two phase I clinical trials of SGN-CD19A, one for patients with B-cell acute lymphoblastic leukemia and one for patients with B-cell non-Hodgkin lymphomas. SGN-CD19A utilizes Seattle Genetics’ industry-leading antibody-drug conjugate technology. The trials are designed to assess the safety and antitumor activity of SGN-CD19A, an ADC targeted to CD19. The studies are phase I, open-label, dose-escalation clinical trials. The primary endpoints are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD19A. In addition, the trials will evaluate antitumor activity, pharmacokinetics, progression-free survival and overall survival. One trial will enroll adult and pediatric patients with relapsed or refractory B-cell ALL, as well as patients with Burkitt lymphoma or leukemia or B-cell lymphoblastic lymphoma. The dose escalation portion of the study is designed to evaluate both weekly and every three week schedules and will enroll approximately 80 patients at multiple centers in the United States. A second trial will enroll patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and mantle cell lymphoma. The dose escalation portion of the trial will evaluate SGN-CD19A administered every three weeks and will enroll approximately 25 patients at multiple centers in the United States.
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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