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News Breaks
July 9, 2014
11:57 EDTCELGCelgene shares higher despite missing primary endpoint in Otezla trial
Celgene Corporation (CELG) this morning said one of its drug, Otezla, did not achieve the primary endpoint in a Phase III trial. WHAT'S NEW: The biopharmaceutical company said Otezla, an oral treatment for adults with active psoriatic arthritis, did not achieve a statistically significant improvement when compared to placebo in its Phase III POSTURE study in patients with ankylosing spondylitis, a inflammatory spinal joint disorder. Despite missing the study's primary endpoint, Celgene said the drug did show "meaningful efficacy" in patients with early stages of the disease who took Otezla for a longer period. The company said evaluation of these efficacy results is ongoing. WHAT'S NOTABLE: Despite missing the primary endpoint, Celgene said that based on an assessment of the safety and efficacy data at week 24, an independent data monitoring committee recommended that the study proceed unchanged. Scott Smith, Global Head of Inflammation & Immunology at Celgene, says that the company is "encouraged" by its preliminary results, especially in patients with shorter disease duration. Smith said the company is planning to start another Phase III trial after it does more analysis. Celgene noted that Otezla is not approved to treat ankylosing spondylitis in any country. PRICE ACTION: Celgene shares were down as much as 1.5% earlier this morning, but are now up $1.12, or 1.31%, to $86.84 in late-morning trading. Year-to-date, shares are up nearly 3%.
News For CELG From The Last 14 Days
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October 21, 2014
09:23 EDTCELGCelgene GED-0301 said to have 67% 12-week remission at high dose in trial
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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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