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March 23, 2014
15:44 EDTCELGCelgene releases new research findings on OTEZLA
Celgene Corporation released new research findings on OTEZLA, apremilast, the company’s oral, selective inhibitor of phosphodiesterase 4, PDE4, from the ESTEEM 1 and 2 phase III studies in patients with moderate to severe plaque psoriasis at the 72nd Annual Meeting of the American Academy of Dermatology, AAD, Annual Meeting in Denver, CO. ESTEEM 1 demonstrated a stable mean PASI improvement of 81 to 88% between weeks 32 and 52 for those patients who were treated for 52 weeks with OTEZLA 30 mg BID and who achieved a PASI-75 score at week 32 . These data are consistent with the mean PASI-75 improvement observed between weeks 16 and 32. In the same group of patients, OTEZLA 30 mg BID continued to demonstrate improvements in difficult-to-treat areas affected by plaque psoriasis...In ESTEEM 2, a significantly higher percentage of patients receiving OTEZLA 30 mg BID achieved a PASI-75 response at week 16, primary endpoint, compared with patients who received placebo. Statistical significance at week 16 was also demonstrated for the major secondary endpoint, static Physician Global Assessment, sPGA, score of clear or almost clear. The beneficial effects of OTEZLA on psoriasis in difficult-to-treat areas of scalp, nails, palms and soles were also demonstrated in ESTEEM 2. After 16 weeks of treatment, OTEZLA 30 mg BID demonstrated significantly higher response rates versus placebo for psoriasis affecting the scalp...“Psoriasis of the nails, scalp and palmoplantar regions is very difficult to treat and can be debilitating for individuals dealing with this chronic disease," said Jennifer Cather, MD, Modern Research Associates, Dallas, Texas. “Results from the 52-week analysis of the ESTEEM program suggest that early responses seen with OTEZLA treatment in multiple efficacy endpoints of plaque psoriasis, including difficult to treat areas, are durable over time. Together with the observed long-term consistent safety and tolerability profile, these findings are encouraging.” A separate analysis of long-term safety and tolerability data from ESTEEM 1 identified no new or unexpected adverse events (AEs) for patients treated with OTEZLA compared with results at week 16...No new or unexpected AEs were identified for patients treated with OTEZLA in ESTEEM 2.
News For CELG From The Last 14 Days
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December 12, 2014
08:01 EDTCELGPiper predicts two large-cap biotechs could be acquired in 2015
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December 9, 2014
14:10 EDTCELGCelgene ISTODAX combination demonstrates complete response in 51% of patients
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08:34 EDTCELGCelgene price target raised to $130 from $102 at Argus
Argus hiked its price target on Celgene as the firm thinks the company posted solid Q3 results, while it is continuing to make progress in its pipeline. Argus keeps a Buy rating on the shares.
08:28 EDTCELGCelgene price target raised to $130 from $112 at UBS
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07:44 EDTCELGAmerican Association for Cancer Research to hold a symposium
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05:46 EDTCELGCelgene presents POMALYST/IMNOVID Phase IIIb study results at ASH meeting
Celgene announced that results from the STRATUS trial, a single-arm phase IIIb study of pomalidomide plus low-dose dexamethasone in patients with relapsed and refractory multiple myeloma were presented at the 56th American Society of Hematology annual meeting. Pomalidomide is marketed as POMALYST in the United States and IMNOVID in the European Union. In the study, 599 patients with refractory, or relapsed and refractory, disease who had previously failed lenalidomide and bortezomib had been enrolled at the time of the data cutoff. The primary endpoint was safety, and key secondary endpoints included pomalidomide exposure, overall response rate, or ORR, duration of response, or DOR, progression-free survival, or PFS, overall survival, or OS, and cytogenetic analyses. Patients had a median five prior therapies. All patients received thromboprophylaxis with low-dose aspirin, low-molecular-weight heparin, or equivalent. At a median follow-up of 6.8 months with a median four cycles received, the median PFS and OS were 4.2 months and 11.9 months, respectively. The ORR was 35%, with 8% of patients achieving at least a very good partial response, or VGPR. The median DOR was 6.8 months. In patients refractory to prior lenalidomide or lenalidomide and bortezomib, similar PFS, OS, and ORR were achieved.
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
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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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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December 7, 2014
16:40 EDTCELGAgios announces new data from Ongoing Phase 1 trial of AG-221
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14:10 EDTCELGAmerican Society of Hematology to hold a meeting
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13:16 EDTCELGCelgene, Acceleron announced data from luspatercept phase 2 clinical trial
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December 6, 2014
09:28 EDTCELGCelgene to hold an analyst and investor event
Analyst and Investor Event being held in conjunction with the American Society of Hematology's 56th Annual Meeting in San Francisco on December 7 at 11 pm. Webcast Link

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