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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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August 26, 2014
11:20 EDTCELGCelgene added to short term buy list at Deutsche Bank
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09:35 EDTCELGActive equity options trading on open
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August 25, 2014
12:19 EDTCELGOn The Fly: Midday Wrap
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10:40 EDTCELGBiotechs rise after InterMune acquired by Roche
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August 20, 2014
08:02 EDTCELGBristol-Myers, Celgene enter collaboration agreement for OPDIVO, ABRAXANE
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August 19, 2014
09:38 EDTCELGActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL GILD TSLA CELG VLO VZ FB HD
07:33 EDTCELGCelgene announces publication of REVLIMID combination results
Celgene announced that results of a study evaluating the combination of REVLIMID with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone in untreated diffuse large b-cell lymphoma were published online ahead of print in the Journal of Clinical Oncology. In a phase II, open label, single arm study, 64 patients with newly diagnosed, untreated, stage II-IV CD20 positive DLBCL received 25 mg of lenalidomide on days 1-10 with standard dose R-CHOP every 21 days for six cycles. All patients received pegfilgrastim on day two of each cycle and aspirin prophylaxis throughout. The primary endpoint was event-free survival with secondary endpoints of progression free survival and overall survival. A one-stage binomial design was used to assess the efficacy and tolerability of REVLIMID with R-CHOP. Of the 64 patients enrolled, 60 were eligible for response evaluation. In these patients, the overall response rate was 98% with 80% achieving a complete response. The 24-month EFS, which was identical to PFS, and OS rates were 59% and 78%, respectively. The company said, "This study demonstrated that the addition of lenalidomide to conventional R-CHOP resulted in similar PFS rates and OS rates between sub-types. This is intriguing as patients with the non-GCB phenotype have traditionally experienced poorer outcomes. The results of this study support further evaluation of this regimen in this sub-type of DLBCL.

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