Key Developments: Celgene Corp (CELG.O)

CELG.O on Nasdaq

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17 Apr 2014
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Latest Key Developments (Source: Significant Developments)

Celgene Corp announces expansive multi-year strategic alliance with FORMA Therapeutics
Tuesday, 1 Apr 2014 07:30am EDT 

FORMA Therapeutics:Says a second strategic collaboration and option agreement with Celgene Corp.New collaboration will enable FORMA to extend its capabilities across broad areas of chemistry and biology.FORMA received an upfront cash payment of $225 million, and the parties entered into a collaboration with a term of 3 ½ years.  Full Article

Celgene Corp and Acceleron Pharma Inc collaborators publishes Nature Medicine Describing Sotatercept and ACE-536 Therapeutic Potential in Beta-thalassemia and Myelodysplastic Syndromes
Monday, 24 Mar 2014 07:30am EDT 

Celgene Corp and Acceleron Pharma Inc:Publication of two papers available online and in April issue of journal Nature Medicine that describe how sotatercept and ACE-536 promote red blood cell formation through an erythropoietin (EPO) independent mechanism in mice.EPO stimulates proliferation of early-stage red blood cell precursors to form new red blood cells.However, anemias associated with defects in the late-stages of red blood cell formation, known as ineffective erythropoiesis, are resistant to EPO treatment.These studies suggest that sotatercept and ACE-536 may promote and regulate maturation of late-stage red blood cell precursors.This distinct activity supports rationale for sotatercept and ACE-536 as potential novel therapies to correct anemia, including EPO-resistant anemia, in diseases such as beta-thalassemia and myelodysplastic syndromes.  Full Article

Celgene Corp announces FDA approval of OTEZLA
Friday, 21 Mar 2014 03:40pm EDT 

Celgene Corp:Says the U.S. Food and Drug Administration (FDA) approves OTEZLA, the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis.  Full Article

Health Canada approves Celgene Corp's POMALYST patients with progressive multiple myeloma
Tuesday, 11 Feb 2014 06:30am EST 

Celgene Corp:Says Health Canada has approved POMALYST oral therapy in combination with dexamethasone, for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed, who have received at least two prior treatment regimens and have demonstrated disease progression on their last regimen.POMALYST received priority review status by Health Canada due to the high unmet medical need that exists and the clinical value that the treatment brings to patients and physicians.The Health Canada approval of POMALYST was based on the MM-003 pivotal study, which was published in The Lancet Oncology in Oct 2013.POMALYST is expected to be commercially available in Mar.POMALYST is a trademark of the company.  Full Article

Celgene Corp reaffirms FY 2014 guidance
Thursday, 30 Jan 2014 07:32am EST 

Celgene Corp:Affirms fiscal 2014 guidance.Says fiscal 2014 total revenue expected to be about $7.5 billion, an increase of 15 percent year-over-year.Says fiscal 2014 adjusted diluted EPS expected to be in the range of $7.00 to $7.20.Says fiscal 2014 GAAP diluted EPS is expected to be in the range of $5.54 to $5.92.Fiscal 2014 revenue of $7.5 bln - Thomson Reuters I/B/E/S.  Full Article

Celgene Corp updates on FY 2013 guidance; gives FY 2014 guidance in line with analysts' estimates
Monday, 13 Jan 2014 12:00pm EST 

Celgene Corp:Says FY 2013 total revenue to be about $6.5 billion and total net product sales are expected to be $6.4 billion.Says FY 2013 adjusted diluted earnings per share (EPS) is expected to be about $5.96.Says FY 2013 based on U.S. Generally Accepted Accounting Principles (GAAP), diluted EPS is expected to be in the range of $3.37 to $3.39.Says FY 2014 total net product sales are expected to be $7.3 billion to $7.4 billion.Says FY 2014 adjusted diluted EPS to be $7.00 to $7.20.Says FY 2014 on a GAAP basis, diluted EPS is expected to be in the range of $5.54 to $5.92.FY 2013 revenue of $6.4 billion and EPS of $6.00 - Thomson Reuters I/B/E/S Estimates.FY 2014 revenue of $7.4 billion and EPS of $7.2 - Thomson Reuters I/B/E/S Estimates.  Full Article

Celgene Corp's Celgene International Sarl Two studies highlight retrospective analyses of phase III study of POMALYST/IMNOVID (Pomalidomide)
Tuesday, 10 Dec 2013 08:30am EST 

Celgene Corp:Says Celgene International Sàrl, a subsidiary updated analyses from MM-003, the company's phase III study of pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone in patients with refractory multiple myeloma who have failed therapy with both bortezomib and lenalidomide.Says administered either alone or in combination were presented at the American Society of Hematology annual meeting in New Orleans, La.Says pomalidomide is marketed as POMALYST in the United States and IMNOVID in the European Union.Says the overall response rate (ORR) for the pomalidomide plus low-dose dexamethasone arm and high-dose dexamethasone arm was 31% vs. 10% (P < 0.001), respectively.Says the results were published in The Lancet Oncology in Sept 2013.  Full Article

Celgene Corp's Celgene International Sàrl announces first analysis of extended dosing with Celgene Epigenetic Agent CC-486 in patients with higher-risk Myelodysplastic Syndromes
Saturday, 7 Dec 2013 09:37pm EST 

Celgene Corp:Says that Celgene International Sàrl, a wholly owned subsidiary of Celgene Corp announced that results from an ad hoc analysis of a subset of subjects with higher-risk myelodysplastic syndrome (MDS) from two ongoing phase I/II studies of oral epigenetic agent CC-486 (oral azacitidine).Says that in this analysis, 23 patients with WHO-defined RAEB-1 or RAEB-2 MDS who received CC-486 300mg once per day (n=20) or 200mg twice per day (n=3) for 14 or 21 days of repeated 28-day cycles.Says that for purposes of this analysis, subject data were analyzed collectively.Says that Hematologic responses were defined by International Working Group (IWG) 2006 criteria.Says that overall response rate (ORR) was calculated as any response of complete or partial remission (CR or PR) and/or any hematologic improvement (HI).Says that marrow complete remission (mCR) was not included in ORR.Says that 14 subjects (61 pct ) had a diagnosis of RAEB-1 and 9 (39 pct) had RAEB-2, median time from diagnosis was 2.1 (0.1 - 33.2) months, and ECOG performance status scores were 0 (n=4, 17 pct), 1 (n=15, 65 pct), or 2 (n=4, 17 pct).Says that overall response was achieved by 11/23 subjects (48 pct) with 4/23 (17 pct) subjects achieving a complete remission, no patients achieving a partial remission and 7/23 patients (30 pct) achieving a hematologic improvement.  Full Article

OncoMed Pharmaceuticals Inc and Celgene Corp enter into agreement - Reuters
Tuesday, 3 Dec 2013 08:11am EST 

OncoMed Pharmaceuticals Inc:Says Celgene Corp would develop and market six of its anti-cancer stem cell experimental drugs for an upfront payment of $155 million.Says it is eligible to receive up to $3 billion in option and payments if Celgene's option to license worldwide rights is exercised and approved.Says Celgene will also buy about $22.25 million of OncoMed's common stock for $15.13 per share.  Full Article

Celgene Corp Receives Positive CHMP Opinion For Abraxane In Combination With Gemcitabine As Treatment For Patients With Metastatic Pancreatic Cancer
Friday, 22 Nov 2013 07:25am EST 

Celgene Corp announced that the European Medicines Agency's (EMA): Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas. The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months. There have been no new treatments approved for pancreatic cancer in nearly seven years. The CHMP positive opinion was based on the results of theMPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, phase III, randomized, international study published in the New England Journal of Medicine in its October 16, 2013 e-publication. The MPACT study involved 861 chemotherapy-naïve patients with metastatic pancreatic cancer at 151 community and academic centers from 11 countries, including North America, Eastern and Western Europe and Australia. In the study, nab-paclitaxel plus gemcitabine demonstrated a statistically significant improvement in median overall survival compared to gemcitabine alone (8.5 vs. 6.7 months) (HR 0.72, P <0.0001); a 28% overall reduction in risk of death.2  Full Article

Mylan sues Celgene for blocking Revlimid, Thalomid generics

- Mylan Inc on Thursday sued Celgene Corp to stop the latter's effort to keep generic versions of two drugs that generate $4.5 billion of annual sales off the market.

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