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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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September 29, 2014
08:55 EDTCELGCelgene price target raised to $115 from $100 at RBC Capital
RBC Capital increased its price target on Celgene (CELG) as the firm now estimates that the company's new oral Crohn's disease drug GED-0301 will generate $1B in sales. The firm expects Celgene's stock to rise further as it predicts that Phase II data for the company's Crohn's treatment will be much better than the data for AbbVie's (ABBV) Crohn's treatment, Humira. RBC predicts that Celgene's long-term 2020 guidance will beat expectations if the company is able to reach a legal settlement with Actavis (ACT.). RBC Capital keeps an Outperform rating on Celgene.
07:26 EDTCELGInforma Business Information to hold a conference
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September 25, 2014
09:36 EDTCELGActive equity options trading on open
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September 24, 2014
13:17 EDTCELGCelgene continues rally after FDA approval of psoriasis drug
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07:01 EDTCELGCelgene OTEZLA to become important revenue generator, says Cantor
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September 23, 2014
15:21 EDTCELGCelgene announces FDA approves Otezla for treating plaque psoriasis
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September 22, 2014
07:21 EDTCELGEBD Group to hold a conference
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September 17, 2014
07:00 EDTCELGConcert Pharmaceuticals announces initiation of CTP-730 Phase 1 trial
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