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AbbVie Inc (ABBV.N)

ABBV.N on New York Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Abbvie Announces First Regulatory Approval Of SKYRIZI
Tuesday, 26 Mar 2019 

March 26 (Reuters) - AbbVie Inc ::ABBVIE ANNOUNCES FIRST REGULATORY APPROVAL OF SKYRIZI™ (RISANKIZUMAB) FOR THE TREATMENT OF PLAQUE PSORIASIS, GENERALIZED PUSTULAR PSORIASIS AND ERYTHRODERMIC PSORIASIS AND PSORIATIC ARTHRITIS IN JAPAN.ABBVIE INC SAYS JAPANESE MINISTRY OF HEALTH, LABOUR AND WELFARE HAS APPROVED SKYRIZI AN INTERLEUKIN-23 INHIBITOR.  Full Article

AbbVie Says FDA Placed A Partial Clinical Hold On All Clinical Trials Evaluating Venetoclax For Investigational Treatment Of Multiple Myeloma
Tuesday, 19 Mar 2019 

March 19 (Reuters) - AbbVie Inc ::ABBVIE PROVIDES UPDATE ON VENCLEXTA®/VENCLYXTO® (VENETOCLAX) MULTIPLE MYELOMA PROGRAM.ABBVIE INC - FDA HAS PLACED A PARTIAL CLINICAL HOLD ON ALL CLINICAL TRIALS EVALUATING VENETOCLAX FOR INVESTIGATIONAL TREATMENT OF MULTIPLE MYELOMA.ABBVIE INC - PARTIAL CLINICAL HOLD FOLLOWS A REVIEW OF DATA FROM ONGOING PHASE 3 BELLINI TRIAL (M14-031).ABBVIE INC - TUESDAY'S ACTION DOES NOT IMPACT ANY OF APPROVED INDICATIONS FOR VENETOCLAX.ABBVIE - PATIENTS WHO ARE CURRENTLY ENROLLED IN STUDIES AND RECEIVING BENEFIT FROM THERAPY MAY CONTINUE WITH TREATMENT, AFTER CONSULTATION WITH PHYSICIAN.ABBVIE INC - INFORMED CLINICAL TRIAL INVESTIGATORS INVOLVED IN STUDIES OF RESULTS AND WILL WORK WITH THEM TO PROCEED AS APPROPRIATE.ABBVIE - A HIGHER PROPORTION OF DEATHS WAS OBSERVED IN VENETOCLAX ARM COMPARED TO CONTROL ARM OF TRIAL IN PHASE 3 BELLINI TRIAL (M14-031).  Full Article

Abbvie Receives CHMP Positive Opinion For Risankizumab For The Treatment Of Moderate To Severe Plaque Psoriasis
Friday, 1 Mar 2019 

March 1 (Reuters) - AbbVie Inc ::ABBVIE RECEIVES CHMP POSITIVE OPINION FOR RISANKIZUMAB (SKYRIZI™) FOR THE TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.ABBVIE - CHMP POSITIVE OPINION FOR RISANKIZUMAB FOR TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS WILL NOW BE REVIEWED BY EUROPEAN COMMISSION.  Full Article

AbbVie Sets Quarterly Cash Dividend Of $1.07 Per Share
Thursday, 21 Feb 2019 

Feb 21 (Reuters) - AbbVie Inc ::SETS QUARTERLY CASH DIVIDEND OF $1.07PER SHARE.  Full Article

Abbvie Reaches Agreement With PCPA For Hepatitis C Treatment Maviret
Thursday, 21 Feb 2019 

Feb 21 (Reuters) - AbbVie Inc ::ABBVIE REACHES AN AGREEMENT WITH THE PAN-CANADIAN PHARMACEUTICAL ALLIANCE (PCPA) FOR ITS HEPATITIS C TREATMENT MAVIRET™.  Full Article

Abbvie Says NDA Accepted For Priority Review By U.S. FDA For Upadacitinib For Treatment Of Moderate To Severe Rheumatoid Arthritis
Tuesday, 19 Feb 2019 

Feb 19 (Reuters) - AbbVie Inc ::ABBVIE ANNOUNCES NEW DRUG APPLICATION ACCEPTED FOR PRIORITY REVIEW BY U.S. FDA FOR UPADACITINIB FOR TREATMENT OF MODERATE TO SEVERE RHEUMATOID ARTHRITIS.ABBVIE INC - ABBVIE USED A PRIORITY REVIEW VOUCHER TO EXPEDITE REVIEW OF UPADACITINIB NDA.ABBVIE INC - ANTICIPATES A REGULATORY DECISION IN Q3 2019.ABBVIE - NDA FOR UPADACITINIB FOR TREATING MODERATE TO SEVERE RHEUMATOID ARTHRITIS IS SUPPORTED BY DATA FROM GLOBAL UPADACITINIB SELECT PHASE 3 PROGRAM.ABBVIE - UPADACITINIB IS ALSO UNDER REVIEW BY EUROPEAN MEDICINES AGENCY FOR TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS.  Full Article

Bioarctic Says U.S. FDA Approves IND Application for Abbv-0805
Monday, 11 Feb 2019 

Feb 11 (Reuters) - BIOARCTIC::BIOARCTIC: U.S. FOOD AND DRUG ADMINISTRATION APPROVES INVESTIGATIONAL NEW DRUG APPLICATIONFOR ABBV-0805.BIOARCTIC AB - FIRST CLINICAL STUDY OF ABBV-0805, PREVIOUSLY NAMED BAN0805, IS PLANNED TO START IN 2019.  Full Article

Coherus BioSciences Announces Global Settlement With AbbVie Securing Rights To Commercialize Its Adalimumab Biosimilar Candidate, CHS-1420
Friday, 25 Jan 2019 

Jan 25 (Reuters) - Coherus BioSciences Inc ::COHERUS BIOSCIENCES ANNOUNCES GLOBAL SETTLEMENT WITH ABBVIE SECURING RIGHTS TO COMMERCIALIZE ITS ADALIMUMAB BIOSIMILAR CANDIDATE, CHS-1420.COHERUS BIOSCIENCES INC - FINANCIAL TERMS ARE NOT DISCLOSED..COHERUS BIOSCIENCES INC - FINANCIAL TERMS ARE NOT DISCLOSED.COHERUS BIOSCIENCES - GLOBAL SETTLEMENTS RESOLVE ALL PENDING DISPUTES BETWEEN PARTIES RELATED TO COHERUS' ADALIMUMAB BIOSIMILAR.COHERUS BIOSCIENCES INC - UNDER U.S. SETTLEMENT, COHERUS' LICENSE PERIOD IN U.S. COMMENCES ON DECEMBER 15, 2023.COHERUS BIOSCIENCES INC - CURRENTLY PREPARING BIOLOGICS LICENSE APPLICATION FOR CHS-1420 FOR SUBMISSION TO FDA WITH ANTICIPATED FILING IN LATE 2019.COHERUS BIOSCIENCES INC - COHERUS WILL PAY ROYALTIES TO ABBVIE.COHERUS BIOSCIENCES INC - CONTINUES TO EVALUATE OPTIONS AND POTENTIAL STRATEGIES FOR EX-U.S. COMMERCIALIZATION OF CHS-1420.  Full Article

Abbvie Reports Q4 Loss Per Share Of $1.23
Friday, 25 Jan 2019 

Jan 25 (Reuters) - AbbVie Inc ::QTRLY LOSS PER SHARE $1.23; QTRLY ADJUSTED EARNINGS PER SHARE $1.90.QTRLY NET REVENUE $8,305 MILLION VERSUS $7,739 MILLION.Q4 EARNINGS PER SHARE VIEW $1.94, REVENUE VIEW $8.38 BILLION -- REFINITIV IBES DATA.SEES FY 2019 GAAP EARNINGS PER SHARE $7.39 TO $7.49; SEES FY 2019 ADJUSTED EARNINGS PER SHARE $8.65 TO $8.75.FY2019 EARNINGS PER SHARE VIEW $8.74 -- REFINITIV IBES DATA.ABBVIE - QTRLY GAAP LOSS PER SHARE INCLUSIVE OF RECENT PARTIAL IMPAIRMENT CHARGE RELATED TO INTANGIBLE ASSETS BOUGHT AS PART OF 2016 DEAL WITH STEMCENTRX.QTRLY GLOBAL HUMIRA SALES OF $4,918 MILLION, UP 0.5 PERCENT ON A REPORTED BASIS.QTRLY INTERNATIONAL HUMIRA SALES $1,303 MILLION, DOWN 17.5 PERCENT ON A REPORTED BASIS.ABBVIE – INTERNATIONALLY Q4 HUMIRA SALES DECLINED 14.8 PERCENT OPERATIONALLY DUE TO DIRECT BIOSIMILAR COMPETITION IN CERTAIN INTERNATIONAL MARKETS.QTRLY GLOBAL IMBRUVICA NET REVENUE OF $1,006 MILLION, UP 42 PERCENT ON A REPORTED BASIS.  Full Article

Abbvie - Co Determined It Will Record Impairment Charge On Intangible Assets Acquired As Part Of Co’S 2016 Acquisition Of Stemcentrx
Friday, 4 Jan 2019 

Jan 4 (Reuters) - AbbVie Inc ::ABBVIE INC - CO DETERMINED IT WILL RECORD IMPAIRMENT CHARGE ON INTANGIBLE ASSETS ACQUIRED AS PART OF CO’S 2016 ACQUISITION OF STEMCENTRX,.ABBVIE INC - ESTIMATED NET IMPACT OF IMPAIRMENT CHARGE & RELATED ADJUSTMENT TO CONTINGENT CONSIDERATION LIABILITIES IS ABOUT $4 BILLION.ABBVIE - TO EVALUATE INFORMATION REGARDING STEMCENTRX-RELATED CLINICAL PROGRAMS, TO MONITOR REMAINING $1 BILLION OF INTANGIBLE ASSETS FOR MORE IMPAIRMENT.  Full Article

UPDATE 5-Biogen scraps two Alzheimer drug trials, wipes $18 bln from market value

CHICAGO/TOKYO, March 21 Biogen Inc and partner Eisai Co Ltd are ending two late-stage trials of their experimental Alzheimer's disease drug aducanumab, a major setback in the quest to find a treatment for the mind-wasting disease and a blow to Biogen, which lost more than $18 billion of its value on Thursday.