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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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April 15, 2015
17:08 EDTCELGCelgene announces phase 2 Apremilast data
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April 13, 2015
09:34 EDTCELGActive equity options trading on open
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05:09 EDTCELGCelgene to purchase 14.35M shares of Mesoblast stock for A$3.82 per share
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April 12, 2015
19:33 EDTCELGCelgene takes stake in Australia's Mesoblast, the Australian says
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April 7, 2015
07:24 EDTCELGCelgene Otezla has growing opportunity, says Bernstein
After interviewing small groups of New York City area dermatologists, Bernstein believes that Celgene's psoriasis,treatment, Otezla, has a growing opportunity, due to its oral dosing, convenience, and lack of immunosuppression. The firm quotes doctors as saying that the drug serves as a useful "stepping stone," for patients who might need more intensive therapy, but want to postpone or avoid biologic Bernstein keeps a $158 price target and Outperform rating on Celgene.

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