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July 9, 2014
07:04 EDTCELGCelgene says OTEZLA did not achieve primary endpoint in Phase III trial
Celgene Corporation announced results of its phase III POSTURE study evaluating OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4, in patients with active ankylosing spondylitis. The OTEZLA arms did not achieve statistically significant improvement versus the placebo arm for the primary endpoint, the percentage of patients who achieve an ASAS 20 response at week 16. However, in a prespecified analysis, meaningful efficacy was observed at Week 24 in a large subset of patients with early-stage disease. Evaluation of the efficacy results is ongoing. An independent data monitoring committee recommended that the study proceed unchanged, based on an assessment of the safety and efficacy data at week 24. According to the protocol, magnetic resonance imaging data will be collected in a subgroup of subjects at week 52 and at additional time points, and radiographs will be taken on all study patients at week 104 and at additional time points. The safety and tolerability data observed in the POSTURE study are consistent with previously reported phase II data in ankylosing spondylitis, as well as six phase III studies of OTEZLA in psoriatic arthritis or psoriasis. No new safety signals were observed. The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study will be presented at an upcoming medical meeting. These results are from an investigational phase III study. OTEZLA is not approved for the treatment of patients with ankylosing spondylitis in any country.
News For CELG From The Last 14 Days
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October 20, 2014
13:26 EDTCELGCelgene I&I franchise boosted by Crohn’s trial data, says William Blair
William Blair said it views the preliminary Phase II efficacy and safety data from mongersen in Crohn’s disease reported by Celgene as encouraging. The firm noted that the 10 mg arm did not achieve significance, but the three data points collectively formed a robust dose-response that William Blair said lends support for the drug's proposed mechanism of action. William Blair believes mongersen complements Celgene’s Inflammation & Immunology portfolio and the firm maintains its Outperform rating on the stock, which is up 4% to $91.65 in afternoon trading.
13:21 EDTCELGCelgene reports Phase II data in Crohn’s Disease to be presented at UEG
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October 17, 2014
13:18 EDTCELGLeerink's biotech analyst holds an analyst/industry conference call
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October 16, 2014
15:10 EDTCELGAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
October 10, 2014
08:41 EDTCELGCelgene reports apremilast significantly improved preexisting psoriasis in study
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08:39 EDTCELGCelgene says data show Apremilast treatment resulted in improved quality of life
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October 8, 2014
07:11 EDTCELGEuropean Academy of Dermatology and Venereology to hold a conference
23rd EADV Congress is being held in Amsterdam, The Netherlands on October 8-12.
October 7, 2014
07:31 EDTCELGCelgene to present long-term efficacy and safety data on oral Otezla
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, announced that the latest research findings on OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4, in plaque psoriasis and psoriatic arthritis will be presented at the 23rd European Academy of Dermatology and Venereology Congress in Amsterdam, October 8 – 12. In total, 11 abstracts will be presented at the meeting. OTEZLA data to be presented include long-term results from Celgene’s pivotal trial, ESTEEM 2 and pooled analyses of safety and tolerability results from the ESTEEM 1 and 2 studies in patients with moderate to severe plaque psoriasis. Additional analyses will evaluate the effect of OTEZLA on pruritus, difficult-to-treat areas such as nail and scalp, and palmoplantar psoriasis, work productivity and improvements in health-related quality of life. An analysis of long-term results from the PALACE clinical trial program evaluating OTEZLA in patients with active psoriatic arthritis will also be presented at the meeting. The analysis assesses the effect of OTEZLA treatment through 52 weeks on the signs and symptoms of psoriatic arthritis, including enthesitis and dactylitis in patients with pre-existing enthesitis or dactylitis.
07:24 EDTCELGAlliance for Regenerative Medicine
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