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)

U.S. Food and Drug Administration Approves Celgene Corp's REVLIMID for Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma
Wednesday, 5 Jun 2013 01:00pm EDT 

Celgene Corp announced the U.S. Food and Drug Administration (FDA) has approved the Company`s supplemental new drug application (sNDA) for REVLIMID (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. The approval was based on the results of MCL-001, a phase II, multi-center, single arm, open label study evaluating lenalidomide in 134 patients with MCL who had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination. Patients were required to have documented refractory disease (defined as without any response of partial response or better during treatment with bortezomib or a bortezomib-containing regimen), or relapsed disease (defined as progression within one year after treatment with bortezomib or a bortezomib-containing regimen). Patients with a creatinine clearance ≥60mL/min were given lenalidomide at 25mg once daily for 21 days every 28 days. Patients with a creatinine clearance ≥30mL/min and <60mL/min were given lenalidomide at a dose of 10mg once daily for 21 days every 28 days. REVLIMID (lenalidomide) is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.  Full Article

Celgene Corp Sees FY 2013 Revenue Guidance To Be Right At Or Slightly Ahead Of Prior Range-Conference Call
Friday, 17 May 2013 04:00pm EDT 

Celgene Corp announced that for fiscal 2013, it expects revenue to be right at or slightly ahead of $6 billion. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $6.151 billion for fiscal 2013.  Full Article

Celgene Corp Raises FY 2013 EPS Guidance; Reaffirms FY 2013 Revenue Guidance
Thursday, 25 Apr 2013 07:29am EDT 

Celgene Corp announced that for fiscal 2013, it raises adjusted diluted EPS guidance to a range of $5.55 to $5.65 from a range of $5.50 to $5.60 and total net product sales guidance is affirmed to $6.0 billion. GAAP diluted EPS expected to be in the range of $4.32 to $4.47 which includes upfront payment expense for alliances and collaborations.  Full Article

Celgene Corp Issues FY 2017 EPS Guidance; Revenue Guidance Above Analysts' Estimates-Conference Call
Tuesday, 26 Feb 2013 03:00pm EST 

Celgene Corp announced that for fiscal 2017, it expects roughly $12 billion in top-line revenue and $13 to $14 a share of EPS. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $11.5 billion and EPS of $13.2 for fiscal 2017.  Full Article

FDA Approves Celgene Corp's Drug For Multiple Myeloma-Reuters
Saturday, 9 Feb 2013 05:16pm EST 

Reuters reported that U.S. regulators have approved a new drug from Celgene Corp for patients with multiple myeloma whose disease has worsened after being treated with other cancer drugs. The U.S. Food and Drug Administration said on Friday it approved the drug, Pomalyst, also known as pomalidomide. The clinical trials have shown that the typical course of treatment is about five cycles.  Full Article

Celgene Corp Reaffirms FY 2013 Guidance
Thursday, 24 Jan 2013 07:30am EST 

Celgene Corp affirmed fiscal 2013 guidance and expects total net product sales to increase approximately 11% year-over-year to approximately $6.000 billion and adjusted diluted EPS to increase approximately 13% year-over-year to a range of $5.50 to $5.60. GAAP diluted EPS expected to be in the range of $4.67 to $4.79 for fiscal 2013. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $6.1 billion for fiscal 2013.  Full Article

Celgene Corp Issues FY 2013 Guidance In Line With Analysts' Estimates; Reaffirms FY 2015 Guidance; Issues FY 2017 Guidance
Monday, 7 Jan 2013 11:30am EST 

Celgene Corp announced that for fiscal 2013, it expects net product sales to be approximately $6.0 billion and adjusted diluted earnings per share (EPS) in the range of $5.50 to $5.60. Based on U.S. Generally Accepted Accounting Principles (GAAP), diluted EPS is expected in the range of $4.67 to $4.79. The Company also reaffirmed 2015 targets of $8.0-9.0 billion in net product sales and adjusted diluted EPS of $8.00 to $9.00. The Company also expects fiscal 2017 target of $12.0 billion in net product sales and adjusted diluted EPS of $13.00 to $14.00. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $6.0 billion and EPS of $5.57 for fiscal 2013; revenue of $8.1 billion and EPS of $8.31 for fiscal 2015.  Full Article

Celgene Corp Announces Phase III Study (MM-003) Of Pomalidomide Plus Low-Dose Dexamethasone
Tuesday, 11 Dec 2012 08:45am EST 

Celgene Corp announced that Celgene International Sàrl, a subsidiary of Celgene Corporation announced data from phase III, multi-center, randomized (2:1), open-label study (MM-003, n=455) 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, administered either alone or in combination. MM-003 met the primary endpoint of improvement in progression-free survival (PFS). PFS was significantly longer in patients who received pomalidomide plus low-dose dexamethasone compared with those who received high-dose dexamethasone (median 3.6 months vs. 1.8 months; hazard ratio HR, 0.45; P < 0.001). According to the study design, an interim analysis of overall survival (OS) was also conducted. In this analysis, pomalidomide plus low-dose dexamethasone demonstrated a highly statistically significant improvement in overall survival that crossed the upper boundary for superiority (median OS not reached vs. 7.8 months; HR, 0.53; P < 0.001). As a result, the Data Monitoring Committee recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed over to pomalidomide plus low-dose dexamethasone.  Full Article

Celgene Corp Announces Results From Study Evaluating Combination Of REVLIMID (lenalidomide) plus VIDAZA (azacitidine)
Monday, 10 Dec 2012 08:24pm EST 

Celgene Corp announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA. In the phase II investigator-initiated study, patients received azacitidine 75 mg/m2/day, days 1-7 followed by lenalidomide 50 mg/day, days 8-28 of 42-day cycles. Treatment was continued until disease progression, unacceptable adverse event or completion of 12 cycles. With 42 patients enrolled in the study, the overall response rate was 41%, with 28% of patients achieving a complete response (CR/CRi). The median time to CR and CRi was 12 and 6 weeks, respectively; the median duration of response (CR/CRi/PR) was 28 weeks (range 6 to >104 weeks). Median overall survival for all patients in the study was 20 weeks (range 1 to >121 weeks) and 69 weeks (range 10 to >121 weeks) for patients who responded to therapy. Additionally, median overall survival for responders was superior to non-responders (69 vs. 15 weeks p<0.01).  Full Article

Celgene Corp Sees FY 2012 Revenue Guidance At Low End Of Prior Range; Issues FY 2015 Guidance In Line With Analysts' Estimates-Conference Call
Wednesday, 14 Nov 2012 05:30pm EST 

Celgene Corp announced that for fiscal 2012, it expects revenue of about $5.5 billion. The Company also expects revenue to be in the range of $8 billion to $9 billion and EPS to be in the range of $8 to $9 in fiscal 2015. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $5.5 billion for fiscal 2012; revenue of $8 billion and EPS of $8.26 for fiscal 2015.  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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