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October 9, 2012
09:02 EDTRHHBY, SGENSeattle Genetics to receive milestone payments as Genentech advances two ADCs
Seattle Genetics (SGEN) will receive undisclosed milestone payments under its antibody-drug conjugate collaboration with Genentech, a member of the Roche Group (RHHBY). The milestones were triggered by Genentech’s advancement of two ADCs utilizing Seattle Genetics technology into phase II clinical development. The phase II randomized, open-label study is designed to evaluate the safety and efficacy of ADCs anti-CD22 and DCDS4501A each in combination with Rituxan in patients with relapsed or refractory follicular non-Hodgkin lymphoma and relapsed or refractory diffuse large B-cell lymphoma.
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December 19, 2014
09:48 EDTRHHBYBiogen should be bought on weakness after Roche drug halted, says Evercore ISI
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09:28 EDTRHHBYOn The Fly: Pre-market Movers
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08:53 EDTRHHBYBiogen drug, trial differs from Roche Alzheimer's drug, says RBC Capital
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08:51 EDTRHHBYBiogen drops 2% after Roche discontinues Alzheimer drug trial
Shares of Biogen (BIIB) are moving lower after Roche (RHHBY) announced the discontinuation of its Alzheimer's drug gantenerumab, which was in Phase III testing. Analysts at Wells Fargo said Roche's trial failure adds risk to Biogen's potential treatment of Alzheimer's. Shares of Biogen are down $8.20 to $345.50 in pre-market trading.
06:12 EDTRHHBYRoche says breast cancer study did not meet PFS superiority endpoint
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06:10 EDTRHHBYRoche to discontinue Phase III study of Alzheimer's disease drug
Roche announced the decision to discontinue SCarlet RoAD, a phase III study of investigational anti-amyloid medicine gantenerumab in prodromal Alzheimer’s disease, based on results of a pre-planned futility analysis and recommendation by the independent Data Monitoring Committee. No new safety signals for gantenerumab were observed in this analysis and the overall safety profile was similar to that seen in the phase I trial, Roche said. Data from the SCarlet RoAD study will be shared with the medical community after full review and analysis, it added. "We are disappointed with these study results because people with early stage Alzheimer's need new medicines that delay disease progression,” said Sandra Horning, M.D., Chief Medical Officer at Roche. "This is the first Phase III trial to evaluate a potential disease-modifying medicine in this early prodromal stage of Alzheimer’s disease. We remain committed to investigating new medicines for this devastating illness."
05:36 EDTRHHBYImmunoGen reports Phase III MARIANNE study met non-inferiority endpoint
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05:33 EDTRHHBYGenentech provides update on Phase III MARIANNE
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December 18, 2014
12:46 EDTRHHBYRoche acquires privately held Dutalys for $133.75M up front
Roche announced that it has agreed to acquire Dutalys GmbH, a privately held biotechnology company based in Vienna, Austria. Dutalys specializes in the discovery and development of fully human, bi-specific antibodies based on their proprietary DutaMab technology, Roche said. Under the terms of the agreement, Roche will make an upfront cash payment of $133.75M to shareholders and make additional contingent payments of up to $355M based on the achievement of certain predetermined milestones.
09:03 EDTSGENSeattle Genetics initiates Phase 1b trial of SGN-CD33A
Seattle Genetics announced initiation of a phase 1b clinical trial of SGN-CD33A in combination with standard of care chemotherapy, including cytarabine and daunorubicin, for patients with newly diagnosed acute myeloid leukemia. The trial will also evaluate SGN-CD33A in the consolidation setting for AML, both in combination with cytarabine and as a single-agent maintenance regimen. SGN-CD33A is a novel antibody-drug conjugate targeted to CD33 utilizing Seattle Genetics’ newest technology. CD33 is expressed on most AML cells regardless of subtype, cytogenetic abnormality or underlying mutational heterogeneity. SGN-CD33A is also under evaluation in an ongoing phase 1 dose escalation trial as a single-agent or in combination with hypomethylating agents for the treatment of patients who have relapsed AML or have declined intensive frontline therapy. The study is a phase 1b, open-label, multi-center, dose-escalation clinical trial designed to evaluate SGN-CD33A administered in combination with frontline standard of care regimens for induction (cytarabine and daunorubicin) and/or consolidation. In addition, the study will evaluate single-agent SGN-CD33A as a maintenance regimen. The primary endpoints are determination of the maximum tolerated dose and safety profile of SGN-CD33A in these settings. In addition, the trial will evaluate anti-leukemic activity, pharmacokinetics, progression-free survival and overall survival. The phase 1b trial will enroll approximately 90 patients at multiple centers in the United States.
December 16, 2014
08:47 EDTRHHBYHemispherx Ampligen provides anti-tumor activity
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05:46 EDTRHHBYRoche launches PCR molecular diagnostic system for point of care environment
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December 15, 2014
05:24 EDTRHHBYExelixis announces Genentech files NDA for cobimetinib, vemurafenib combination
Exelixis (EXEL) announced its collaborator Genentech, a member of the Roche Group (RHHBY), has completed the filing of its New Drug Application, or NDA, with the FDA for cobimetinib, a specific MEK inhibitor discovered by Exelixis, in combination with vemurafenib for previously untreated patients with unresectable locally advanced or metastatic melanoma harboring a BRAF V600 mutation. Cobimetinib has received Fast Track designation by the FDA. Roche submitted a Marketing Authorization Application for the combination to the European Medicines Agency in September of this year. The NDA is based on data from the coBRIM trial, a phase 3 pivotal trial conducted by Genentech in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma.
December 12, 2014
05:52 EDTRHHBYRoche announces retirement of Genentech research head
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December 9, 2014
12:22 EDTRHHBYPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
07:44 EDTRHHBYAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
19:42 EDTSGENSeattle Genetics says Adcetris 'demonstrates antitumor activity'
Seattle Genetics highlighted two separate Adcetris data presentations in relapsed/refractory and frontline diffuse large B-cell lymphoma, or DLBCL, at the 56th American Society of Hematology, or ASH, Annual Meeting and Exposition. Adcetris is an antibody-drug conjugate directed to CD30, which is expressed in classical Hodgkin lymphoma, anaplastic large cell lymphoma and several other types of non-Hodgkin lymphoma. Seattle Genetics CEO Clay Siegall said, “The updated phase 2 data at ASH demonstrate encouraging activity of Adcetris in relapsed/refractory DLBCL, even when CD30 is undetectable by standard immunohistochemistry methods. In addition, our data show that Adcetris can be safely combined with RCHOP in the frontline setting with a strong complete remission rate in high-intermediate and high-risk patients. The activity observed supports our plans to initiate a randomized phase 2 clinical trial of Adcetris for relapsed CD30-positive DLBCL patients during 2015 and to pursue possible frontline DLBCL combination trials."
19:41 EDTSGENSeattle Genetics says planning phase 1b combination trial for SGN-CD33A
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10:04 EDTSGENSeattle Genetics highlights 'encouraging' long-term outcomes in Phase 1 trial
Seattle Genetics highlighted multiple ADCETRIS data presentations in frontline and salvage Hodgkin lymphoma at the 56th American Society of Hematology Annual Meeting and Exposition taking place in San Francisco, CA, December 6-9. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma, a type of T-cell lymphoma. Data highlighted in oral sessions include encouraging long-term outcomes from a phase 1 trial evaluating ADCETRIS in combination with AVD chemotherapy in frontline HL, as well as strong activity evaluating ADCETRIS combination therapy in second-line HL and ADCETRIS monotherapy or combination therapy in frontline HL patients age 60 and older. In addition, encouraging data from multiple investigator-sponsored trials were featured in oral and poster sessions evaluating ADCETRIS in frontline and salvage HL and in non-Hodgkin lymphoma settings.
08:33 EDTSGENSeattle Genetics should be bought on weakness, says RBC Capital
RBC Capital believes that Seattle Genetics' shares could be under pressure today due to questions around its AETHERA data and the checkpoint inhibitor efficacy of its ADCETRIS drug. However, the firm says that other issues are more important over the longer term, including the efficacy of ADCs as a cancer treatment, the emergence of other pipeline products and therapeutic approaches, and efficient development pathways to the market. The firm keeps a $48 price target and Outperform rating on Seattle Genetics.
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