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December 14, 2012
10:55 EDTABT, ABT, CELG, CELG, GILD, GILD, INFI, INFI, PCYC, PCYC, PFE, PFE, RHHBY, RHHBY, SGEN, SGENLeerink's biotech analyst holds a post-ASH update conference call
Biotech Analyst Liang discusses new agents for lymphomas including new data on kinase inhibitors Ibrutinib (PCYC), GS-1101 (GILD), IPI-145 (INFI), Bcl-2 inhibitor ABT-199 (ABT/Roche) on the Analyst/Industry conference call to be held on December 14 at 11 am.
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December 9, 2014
05:43 EDTPCYCPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:27 EDTPCYCPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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05:22 EDTCELGCelgene reports REVLIMID study data suggests improved response rates, PFS, OS
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05:17 EDTCELGCelgene reports Vidaza Phase III study shows doubled overall survival times
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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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16:00 EDTGILDOptions Update; December 8, 2014
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14:06 EDTCELGCelgene reports luspatercept, sotatercept increased hemoglobin levels in trials
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13:54 EDTCELGCelgene announces results from phase lll Revlimid study
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13:45 EDTPCYCTG Therapeutics says TG-1101 well tolerated in Phase 2 study
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13:32 EDTPFEPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
10:47 EDTINFIInfinity reports updated Phase 1 data from duvelisib study, says well tolerated
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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.
10:02 EDTGILDGilead presents follow-up data from Zydelig registrational studies
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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.
08:32 EDTPCYCTrout Group to hold events at ASH 2014
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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07:36 EDTCELGAgios announces Celgene to extend discovery phase of collaboration to April 2016
Agios Pharmaceuticals (AGIO) announced that Celgene (CELG) has elected to extend the period of its exclusivity for an additional year to April 2016 under the global strategic collaboration agreement. The two companies have been working together since April 2010 to discover, develop and commercialize disease-altering therapies in oncology arising from Agios' cancer metabolism research platform. The terms of the collaboration extension are consistent with previously agreed upon financial terms. As a result of the extension, Celgene will maintain its exclusive option to drug candidates that emerge from Agios' cancer metabolism research platform through April 2016. Agios will receive a $20M payment. Following this extension, the discovery portion of the collaboration will expire on April 14, 2016. Under the terms of the original agreement announced in April 2010, Agios leads research, preclinical and early development efforts through Phase 1, while Celgene receives an option to obtain exclusive rights either upon IND acceptance or at the end of Phase 1, to further development and commercialize medicines emerging from Agios' cancer metabolism research. Celgene would lead and fund global development and commercialization of some of these drugs, and Agios would retain development and commercialization rights for certain drugs in the United States. On all programs, Agios is eligible to receive up to $120M in milestone-based payments as well as royalties on any sales.
07:17 EDTCELGCelgene price target raised to $131 from $120 at Cantor
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05:35 EDTCELGCelgene REVLIMID, low-dose dexamethasone increased PFS
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