Key Developments: Celgene Corp (CELG.O)

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Latest Key Developments (Source: Significant Developments)

Celgene Corporation says Celgene International Sàrl's VIDAZA (Azacitidine for Injection) receives positive CHMP opinion
Friday, 25 Sep 2015 03:00am EDT 

Celgene International Sàrl:Says that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion.Positive opinion for an expanded indication of VIDAZA(azacitidine for injection) for the treatment of adult patients aged 65 years or older with acute myeloid leukaemia (AML) who are not eligible for haematopoietic stem cell transplantation (HSCT).Celgene International Sàrl is a wholly owned subsidiary of Celgene Corporation.  Full Article

Celgene and Nurix announce collaboration targeting protein homeostasis
Wednesday, 16 Sep 2015 07:00am EDT 

Celgene Corp:Celgene and nurix announce collaboration targeting protein homeostasis for next-generation therapies in oncology, inflammation and immunology.Nurix inc says under the terms of the collaboration, Celgene will make an upfront payment to nurix of $150 million.Nurix inc says deal also includes an undisclosed equity investment, option to license future programs.Nurix inc says nurix will control and is responsible for all drug discovery and development activities through the end of phase 1 clinical trials.Nurix, inc-Celgene may license global development and commercialization rights to a program in exchange for payments totaling up to $405 million.Nurix, inc-Celgene will have worldwide rights to collaboration products, with the exception of certain collaboration products.  Full Article

Celgene prices $8 billion of senior unsecured notes
Tuesday, 4 Aug 2015 07:30am EDT 

Celgene Corporation:Announces the pricing of five series of senior unsecured notes for an aggregate principal amount of $8.0 billion.  Full Article

Celgene Corp raises FY 2015 adjusted EPS guidance
Thursday, 23 Jul 2015 07:30am EDT 

Celgene Corp:Sees FY 2015 Adjusted EPS Guidance Raised.Sees FY 2015 total net product sales are expected to be in the range of $9.0 billion to $9.5 billion.Sees FY 2015 REVLIMID net sales are expected to be in the range of $5.6 billion to $5.7 billion.Sees FY 2015 ABRAXANE net sales are expected to be in the range of $1.0 billion to $1.25 billion.Sees FY 2015 Adjusted diluted EPS is expected to be in the range of $4.75 to $4.85, up from the original range of $4.60 to $4.75.Sees FY 2015 GAAP diluted EPS to be in the range of $2.17 to $2.46, lowered from the original range of $2.97 to $3.1.  Full Article

Celgene Corp to acquire Receptos
Tuesday, 14 Jul 2015 04:58pm EDT 

Celgene Corp:To acquire Receptos, advancing in immune-inflammatory diseases.Says Celgene will pay $232.00 per share in cash, or a total of approximately $7.2 billion.Celgene will acquire all of the outstanding shares of common stock of Receptos through a tender offer, followed by a second-step merger.Says transaction has been approved by the boards of directors of both companies.Says Celgene expects to fund the transaction through a combination of existing cash and new debt.Says j.p. morgan and Citi are acting as financial advisors to Celgene on the transaction.  Full Article

Celgene Corp and Juno announces ten-year collaboration
Monday, 29 Jun 2015 04:05pm EDT 

Celgene Corp:Celgene and Juno announce ten-year collaboration to advance potentially groundbreaking immunotherapies for patients with cancer and autoimmune diseases.Says gains option to commercialize Juno programs outside North America and co-promote certain programs globally.To make initial payment of approximately $1 billion which includes the purchase of 9.1 million shares of Juno stock at $93.00 per share.Says Juno gains option to co-develop and co-promote select Celgene programs.Says additionally, subject to additional obligations, Celgene may select a third program.Says parties will share global costs and profits with 70% allocated to Celgene and 30% allocated to Juno.Will lead global development and commercialization, subject to a Juno Co promote option in the US and certain EU territories.Says has entered into a standstill agreement and agreed to certain lock-up provisions on its share ownership.Says transaction has been approved by the boards of directors of both companies.Says Celgene and Juno currently expect to complete the transaction during the third quarter of 2015.  Full Article

Celgene Corp announces additional $4 billion share repurchase authorization
Wednesday, 17 Jun 2015 07:30am EDT 

Celgene Corp:Says its Board of Directors has authorized the repurchase of up to an additional $4.0 billion of the company's common stock.This open-ended program is effective immediately.The company now has a total of about $5.2 billion remaining from previous authorizations plus the new authorization.  Full Article

Celgene Corp updates results from mm-020/ifm 07-01
Friday, 12 Jun 2015 07:30am EDT 

Celgene Corp:Updated results from mm-020/ifm 07-01 (first) study of revlimid presented at European hematology annual congress.Updated analysis of progression-free survival demonstrated median of 26 months for patients treated with continuous rd versus 21.9 months for mpt.Incidence of solid tumors was similar in continuous rd and mpt arms (3.4 pct and 3.3 pct, respectively) and 5.9 pct in rd18 arm.Says updated analysis of safety in the continuous rd arm remained similar with extended follow-up to previously reported data.  Full Article

Celgene Corp and Lycera Corp says exclusive strategic collaboration
Tuesday, 9 Jun 2015 07:00am EDT 

Celgene Corp:Lycera and Celgene announce an exclusive strategic collaboration to advance novel immune modulators.Lycera corp says under the terms of the agreement, lycera receives an $82.5 million upfront cash payment.Lycera corp says upfront payment includes an exclusive option for Celgene to license lycera's portfolio of ex vivo rorgamma agonist compounds.Lycera corp says lycera has the potential to receive near term payments of an additional $22.5 million.Lycera says Celgene gets exclusive right to buy lycera upon conclusion of option period or achievement by lycera of pre-specified clinical milestones.Lycera says during the option period, lycera will retain full control of its research and development programs.Lycera says following the exercise of the option to acquire lycera, shareholders will be also eligible to receive future success-based milestones.  Full Article

Analysis of Phase II Data for Celgene Corp's Investigational Oral GED-0301 in patients with Active Crohn's Disease presented at digestive disease week
Tuesday, 19 May 2015 08:15am EDT 

Celgene Corp:Says that a post-hoc subgroup analysis of a double-blind, placebo-controlled, randomized, multicenter phase II trial of GED-0301 (mongersen) in patients with active Crohn's disease was presented at Digestive Disease Week (DDW) in Washington, D.C.Patients with more severe Crohn's disease or longer disease duration treated with GED-0301 160 mg experienced clinical remission and response rates greater than placebo.Phase II trial enrolled 166 adult patients with moderate-to-severe Crohn's disease with documented inflammatory lesions in the terminal ileum and/or right colon.Patients with known lesions in the stomach, proximal small intestine, transverse colon, and/or left colon, strictures, fistulae, perianal disease, extraintestinal manifestations, active or recent infections or a history of malignancy were excluded.Patients were randomly assigned to receive treatment for two weeks with one of three daily doses of GED-0301 or placebo and then evaluated for responses at days 15, 28 and 84.Primary efficacy endpoint of the study was the percentage of patients with clinical remission, defined as a CDAI score below 150 at day 15, which was maintained at day 28.Secondary endpoints included clinical response defined as a reduction of CDAI score of 100 points or 70 points at day 15 and day 28.  Full Article

Celgene says patent-fighting hedge fund manager wants to short its shares

NEW YORK - Celgene Corp, one of the world's largest biotechnology companies, has accused U.S. hedge fund manager Kyle Bass of attempting to profit from his attempts to wipe out several major drug patents through his Coalition for Affordable Drugs.

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