Key Developments: Celgene Corp (CELG.O)

CELG.O on Nasdaq

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19 Dec 2014
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Latest Key Developments (Source: Significant Developments)

Bristol-Myers Squibb and Celgene enter clinical collaboration agreement to evaluate immunotherapy and chemotherapy combination regimen
Wednesday, 20 Aug 2014 08:00am EDT 

Bristol-Myers Squibb Co:To establish a clinical trial collaboration with Celgene.To evaluate safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, OPDIVO, and Celgene's nab (technology-based chemotherapy ABRAXANE), in a Phase I study.Multiple tumor types will be explored in the study including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC).Proprietary name OPDIVO has been proposed in the U.S. and other countries, but remains subject to health authority approval.Study is expected to begin in the fourth quarter of 2014 to be conducted by Celgene.  Full Article

Celgene Corp Reports patients with diffuse Large B-Cell Lymphoma receiving Oral REVLIMID with Standard R-CHOP Achieved 98 pct Overall Response Rate and 80 pct complete Response Rate
Tuesday, 19 Aug 2014 07:30am EDT 

Celgene Corp:Says results of study evaluating combination of REVLIMID (lenalidomide) with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP) in untreated diffuse large b-cell lymphoma (DLBCL) were published.Says in phase II, open label, single arm study, by Dr. Grzegorz Nowakowski of the Mayo Clinic, 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.Says all patients received pegfilgrastim on day two of each cycle and aspirin prophylaxis throughout.Says primary endpoint was event-free survival (EFS) with secondary endpoints of progression free survival (PFS) and overall survival (OS).Says one-stage binomial design was used to assess the efficacy and tolerability of REVLIMID with R-CHOP.Says of the 64 patients enrolled, 60 were eligible for response evaluation.These patients, the overall response (OR) rate was 98 pct (59/60) with 80 pct (48/60) achieving a complete response (CR).Says 24-month EFS, which was identical to PFS, and OS rates were 59 pct (48-74 pct) and 78 pct (68-90 pct), respectively (95 pct CI).  Full Article

Health Canada Approves Celgene Corp 's ABRAXANE Plus Gemcitabine for first-line treatment of patients with metastatic pancreatic cancer
Wednesday, 6 Aug 2014 08:00am EDT 

Celgene Corp:Says Health Canada has approved ABRAXANE for Injectable Suspension (paclitaxel powder for injectable suspension) (nanoparticle, albumin-bound [nab] paclitaxel) for first-line treatment of adult patients with metastatic pancreatic cancer.Approval is welcome news for Canadians who are diagnosed with metastatic pancreatic cancer, and represents first approved treatment for this disease in nearly two decades.Health Canada approval was based on results of MPACT, an open-label, phase III, randomized, international study which was published in New England Journal of Medicine in Oct. 2013.  Full Article

Celgene Corp raises FY 2014 guidance
Thursday, 24 Jul 2014 07:32am EDT 

Celgene Corp:Raised FY 2014 total revenue to about $7.6 bln from $7. bln.Raised FY 2014 adjusted diluted EPS to a range of $3.60 to $3.65 from the previous range of $3.50 to $3.60, an increase of about 22 pct over 2013 adjusted diluted EPS.FY 2014 GAAP diluted EPS is expected to be in the range of $2.46 to $2.55 from the previous range of $2.47 to $2.59.FY 2014 revenue of $7.53 bln and EPS of $3.67 - Thomson Reuters I/B/E/S.  Full Article

Celgene reports results from phase III POSTURE Study Evaluating Oral OTEZLA in Ankylosing Spondylitis
Wednesday, 9 Jul 2014 07:00am EDT 

Celgene Corp:Declares results of its phase III POSTURE study evaluating OTEZLA, the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with active ankylosing spondylitis.OTEZLA arms did not achieve statistical improvement versus the placebo arm for the primary endpoint, the percentage of patients who achieve an ASAS (Assessment of SpondyloArthritis international Society) 20 response at week 16.Evaluation of the efficacy results is ongoing.  Full Article

Celgene Corp reaffirms FY 2017 revenue guidance - Conference Call
Wednesday, 11 Jun 2014 01:00pm EDT 

Celgene Corp:Expects FY 2017 revenue of $13 billion to $14 billion overall.FY 2017 revenue of $13 billion - Thomson Reuters I/B/E/S.  Full Article

Celgene Corp's subsidiary updates phase III clinical trials of OTEZLA
Wednesday, 11 Jun 2014 07:30am EDT 

Celgene Corp:Says a subsidiary Celgene International Sarl, results of additional analyses from the phase III clinical trials of OTEZLA, the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4).These included long-term (52-week) analyses from the PALACE 1, 2 and 3 trials of the impact of OTEZLA on psoriatic arthritis disease activity, safety and tolerability, in addition to a separate 16-week work productivity analysis from PALACE 1.The findings were presented at the European League Against Rheumatism Annual Congress (EULAR 2014) in Paris, France.  Full Article

Celgene announces appointment of Chief Financial Officer
Thursday, 22 May 2014 06:00am EDT 

Celgene Corp:Appoints Peter Kellogg as Executive Vice President, Chief Financial Officer.  Full Article

Celgene Corp gives FY 2017 revenue guidance in line with analysts' estimates - Conference Call
Monday, 19 May 2014 01:30pm EDT 

Celgene Corp:Says for FY 2017 it expect $13 billion to $14 billion in sales by that period of time.FY 2017 revenue of $13.14 billion - Thomson Reuters I/B/E/S.  Full Article

Celgene announces public offering of Senior Notes due 2019, 2024 and 2044 - Form 8-K
Wednesday, 7 May 2014 02:18pm EDT 

Celgene Corp:Announces underwritten public offering of $500 mln aggregate principal amount of 2.250pct Senior Notes due 2019, $1 bln aggregate principal amount of 3.625pct Senior Notes due 2024 and $1 bln aggregate principal amount of 4.625pct Senior Notes due 2044.Intends to use the net proceeds for general corporate purposes.Merrill Lynch, Pierce, Fenner & Smith Incorporated, Credit Suisse Securities (USA) LLC, Goldman, Sachs & Co. and Morgan Stanley & Co. LLC acts as underwriters.  Full Article

CORRECTED-BUZZ-U.S. Stocks on the Move-McDonald's, Taser, ClubCorp, Celgene

(Removes item on Canadian Solar, which was based on an erroneous report. The error also appeared in previous versions of U.S. Stocks on the move)

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