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News Breaks
March 2, 2013
16:09 EDTCELGCelgene presents results from 1st phase III study in psoriasis ESTEEM 1
Celgene International Sŕrl, a subsidiary of Celgene presented the results from ESTEEM 1, the Company’s first phase III study in psoriasis, at the American Academy of Dermatology annual meeting in Miami, Florida. The company previously announced statistical significance for the primary and major secondary endpoint of PASI-75 at Week 16 and the Static Physician Global Assessment for patients receiving apremilast in the ESTEEM 1&2 phase III studies. ESTEEM 1&2 are the phase III registrational randomized, placebo-controlled studies evaluating the company’s oral small-molecule inhibitor of phosphodiesterase-4 in patients with moderate-to-severe chronic plaque psoriasis. Statistical significance at week 16 was also demonstrated in the major secondary endpoint, Static Physician Global Assessment (sPGA) of clear or almost clear (P<0.0001), and other key secondary endpoints (change in BSA, Pruritus VAS, DLQI), as well as in assessments of difficult to treat areas (nail and scalp psoriasis). An NDA submission to the U.S. Food and Drug Administration, based on the combined ESTEEM 1&2 studies for psoriasis, is expected in the second half of 2013. The Company previously announced it expects to file a separate NDA for psoriatic arthritis in the first quarter of 2013. A combined PsA/psoriasis MAA submission in Europe is also planned for the second half of 2013.
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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