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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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July 29, 2015
20:10 EDTCELGCelgene says patent challenges are baseless, Reuters reports
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July 28, 2015
07:31 EDTCELGCelgene commences tender offer for Receptos
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July 27, 2015
10:40 EDTCELGIsis 'most obvious' Biogen takeover target, TheStreet's Feuerstein says
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08:38 EDTCELGAnalysts divided on Biogen following $85 selloff
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July 24, 2015
08:08 EDTCELGCelgene price target raised to $190 from $156 at Canaccord
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July 23, 2015
19:50 EDTCELGCelgene price target raised to $163 from $146 at Cantor
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10:50 EDTCELGCelgene positioned for sustainable growth, says Piper Jaffray
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07:37 EDTCELGCelgene reports Q2 Revlimid sales up 19% to $1.44B
ABRAXANE® sales for the second quarter were $244 million, a 13 percent increase. POMALYST®/IMNOVID® sales for the second quarter were $235 million, an increase of 46%. VIDAZA® sales in the second quarter remained flat year-over-year at $152 million. OTEZLA® sales for the second quarter were $90 million, increasing 49 percent over the first quarter of 2015.
07:37 EDTCELGCelgene raises FY15 adjusted EPS view to $4.75-$4.85 from $4.60-$4.75
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07:32 EDTCELGCelgene reports Q2 adjusted EPS $1.23, consensus $1.20
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July 22, 2015
15:26 EDTCELGNotable companies reporting before tomorrow's open
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09:28 EDTCELGBiogen downgraded to Neutral at Piper Jaffray after Alzheimer's data
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July 21, 2015
11:03 EDTCELGCelgene treatment of pediatric Crohn's disease receives FDA orphan designation
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06:29 EDTCELGCelgene price target raised to $160 from $147 at Piper Jaffray
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06:24 EDTCELGPiper expects 'stronger, bolder' move from Biogen
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