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AbbVie Inc (ABBV.K)

ABBV.K on New York Consolidated

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17 Feb 2017
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Latest Key Developments (Source: Significant Developments)

Biogen and AbbVie's drug approved in EU
Tuesday, 5 Jul 2016 08:00am EDT 

Biogen Inc : Biogen and AbbVie's once-monthly zinbryta(tm) (daclizumab) approved in European Union for treatment of multiple sclerosis . Zinbryta significantly reduced multiple measures of disease activity in patients with relapsing forms of MS .Targeted mechanism of action of zinbryta did not cause broad, prolonged depletion of studied immune cell types.  Full Article

Abbvie announces fourth breakthrough therapy designation granted by FDA
Wednesday, 29 Jun 2016 07:30am EDT 

AbbVie Inc : Abbvie announces fourth breakthrough therapy designation granted by the U.S. Food and drug administration (FDA) for ibrutinib (imbruvica) for chronic graft-versus-host-disease (CGVHD), a rare condition with limited treatment options . FDA also granted therapy orphan drug designation (ODD) for condition . Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an Abbvie company and Janssen Biotech Inc .Versus-Host-Disease (CGVHD), a rare condition with limited treatment options.  Full Article

Infinity regains worldwide rights to duvelisib; ends collaboration with AbbVie
Tuesday, 28 Jun 2016 06:55am EDT 

Infinity Pharmaceuticals Inc : Infinity undertakes restructuring of workforce . Infinity will also reduce its workforce by 58 percent . Says neither infinity nor abbvie have future financial obligations to other party . Exploring strategic options for program that could enable submission of global regulatory applications, commercialization for duvelisib . Says will not proceed with phase 1b/2 study of duvelisib in combination with venetoclax . Says ipi-549 is only investigational pi3k-gamma inhibitor in clinical development . Continuing to focus on filing nda for duvelisib with u.s. Food and drug administration (fda) in q4 of 2016 . Plans to seek feedback on dynamo data from fda . Strategic decisions include closing bravura, a phase 3 study of duvelisib, contempo, a phase 1b/2 study of duvelisib . Also expects to report topline data from duo, predicated on results of an interim analysis, in q3 of 2016 .Infinity regains worldwide rights to duvelisib following mutual agreement with abbvie to end collaboration.  Full Article

Coherus BioSciences provides update on IPRs
Monday, 13 Jun 2016 02:04pm EDT 

Coherus BioSciences Inc : Received favorable decision from Patent Trial and Appeal Board related to dosing regimen for Abbvie's Humira (Adalimumab) .Coherus BioSciences provides update on IPRs.  Full Article

Abbvie reports 17.93 pct passive stake in Reata as of May 25 - SEC filing
Monday, 6 Jun 2016 05:25pm EDT 

Reata Pharmaceuticals Inc :Abbvie Inc reports 17.93 pct passive stake in Reata Pharmaceuticals Inc as of May 25, 2016 - SEC filing.  Full Article

AbbVie says entered share repurchase agreement with JPMorganChase
Thursday, 2 Jun 2016 12:16pm EDT 

Abbvie Inc : On June 1, entered into an accelerated share repurchase agreement with JPMorganChase to repurchase $3.8 billion of stock .AbbVie Inc says JPMorgan is expected to make an initial delivery of about 54.4 million shares of AbbVie's common stock on June 2, 2016.  Full Article

Moody's downgrades AbbVie to Baa2; stable outlook
Wednesday, 1 Jun 2016 06:08pm EDT 

Moody's: Moody's downgrades AbbVie to Baa2; stable outlook . Baa2 rating reflects its large scale with a revenues of about $23 billion, its high margins and its strong cash flow . In light of continuing revenue concentration in Humira, this degree of financial leverage positions AbbVie at the Baa2 rating level .Rating outlook is stable, reflecting expectations for good organic growth offset by product concentration risk.  Full Article

Coherus Biosciences provides update on '135 IPR
Tuesday, 17 May 2016 10:31am EDT 

Coherus Biosciences Inc : Coherus Biosciences provides update on '135 IPR . Coherus Biosciences Inc - Received favorable decision from Us Patent and Trademark Office instituting co's petition for inter partes review of Abbvie's U.S. Patent 8,889,135 . Coherus Biosciences Inc - Says "Confident that this will lead to a final decision nullifying '135 patent" .Coherus Biosciences Inc - Abbvie's U.S. Patent directed to dosing regimen in which 40 MG of Humira administered subcutaneously every 13 to 15 days to treat Rheumatoid Arthritis.  Full Article

Bristol-Myers says European Commission approval of Empliciti for treatment of multiple myeloma
Wednesday, 11 May 2016 02:25pm EDT 

Bristol-myers Squibb Co :Bristol-Myers squibb and abbvie announce european commission approval of empliciti(tm) (elotuzumab) for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.  Full Article

FDA expands Imbruvica label to include survival data
Monday, 9 May 2016 08:08am EDT 

AbbVie Inc : U.S. FDA expands Imbruvica (ibrutinib) label to include overall survival data in previously untreated chronic lymphocytic leukemia . Label now includes overall survival (OS) results in previously-untreated cll/sll patients from phase 3 resonate tm -2 (pcyc-1115) trial .U.S. FDA expands Imbruvica (ibrutinib) label to new indication for small lymphocytic lymphoma (SLL) patients.  Full Article

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BRIEF-Abbvie announces $5 bln increase to stock repurchase program

* Abbvie announces $5 billion increase to stock repurchase program Source text for Eikon: Further company coverage: