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March 14, 2014
14:18 EDTCELGCelgene lower after U.K. draft guidance on Revlimid use
Shares of drug maker Celgene (CELG) are sinking after a U.K. guidance body refused, in a preliminary decision, to recommend expanded use of the company's Revlimid drug in the country. WHAT'S NEW: The U.K.'s National Institute for Health and Care Excellence, or NICE, declined to recommend the use of Revlimid by multiple myeloma patients who had been treated one time with another drug, bortezomib. Instead, NICE will recommend that Revlimid only be given to patients who have received two or more prior therapies, the regulator stated. Celgene failed to present data comparing the effectiveness of Revlimid to other drugs, and it is unclear if Revlimid is as effective as giving patients a second round of bortezomib, NICE stated. Additionally, Celgene's own model showed that the drug would not be cost effective at this stage, NICE added. ANALYST REACTION: In a note to investors earlier today, Wells Fargo analyst Dr. Brian Abrahams wrote that the weakness in Celgene's stock today may also have been triggered by the scheduling of a hearing in a patent case on April 29, which was earlier than previously expected. However, the scheduling of the hearing was known two days ago, the analyst stated. The hearing could be important in judging how long Celgene will have exclusive rights to Revlimid, but the outcome will not be known for another year or more, the analyst believes. Abrahams also said the U.K.'s decision is not significant, since the country is more stringent than other nations in these matters. The country is likely to change its decision in the future, based on data from a study of Revlimid, according to the analyst. Abrahams recommended that investors buy Celgene shares on today's weakness and added the stock to the firm's Priority Stock List. PRICE ACTION: In afternoon trading, Celgene fell $5.44, or 3.5%, to $150.56.
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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