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AbbVie Inc (ABBV.N)

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Latest Key Developments (Source: Significant Developments)

Abbvie Announces Positive Results From Second Phase 3 Study Of Elagolix In Women With Uterine Fibroids
Tuesday, 13 Mar 2018 

March 13 (Reuters) - Abbvie Inc ::ABBVIE ANNOUNCES POSITIVE TOPLINE RESULTS FROM SECOND PHASE 3 STUDY EVALUATING INVESTIGATIONAL ELAGOLIX IN WOMEN WITH UTERINE FIBROIDS.ABBVIE INC - ‍SECOND OF TWO PIVOTAL PHASE 3 STUDIES (ELARIS UF-II) MET PRIMARY EFFICACY ENDPOINT AND ALL RANKED SECONDARY ENDPOINTS​.ABBVIE INC - ‍RESULTS WERE CONSISTENT WITH FIRST PHASE 3 STUDY​.ABBVIE INC - STUDY ALSO MET ALL RANKED SECONDARY ENDPOINTS (P<0.02) AT MONTH SIX.ABBVIE INC - ‍RESULTS DEMONSTRATED ELAGOLIX, WITH LOW-DOSE ADD-BACK THERAPY, REDUCED HEAVY MENSTRUAL BLEEDING COMPARED TO PLACEBO​.ABBVIE INC - ‍WOMEN IN STUDY WILL CONTINUE IN EITHER POST-TREATMENT FOLLOW-UP OR A BLINDED SIX-MONTH EXTENSION STUDY​.  Full Article

FDA accepts Novartis submission of biosimilar version of Humira
Tuesday, 16 Jan 2018 

Jan 16 (Reuters) - Novartis AG ::SANDOZ REGULATORY SUBMISSION FOR PROPOSED BIOSIMILAR ADALIMUMAB ACCEPTED BY FDA.US FOOD AND DRUG ADMINISTRATION (FDA) ACCEPTED ITS BIOLOGICS LICENSE APPLICATION (BLA), SUBMITTED UNDER THE 351 (K) PATHWAY, FOR PROPOSED BIOSIMILAR ADALIMUMAB TO THE REFERENCE MEDICINE, HUMIRA.‍DATA PACKAGE PROVIDED IS EXPECTED TO DEMONSTRATE THAT SANDOZ PROPOSED BIOSIMILAR ADALIMUMAB MATCHES REFERENCE BIOLOGIC MEDICINE IN TERMS OF SAFETY, EFFICACY AND QUALITY​.  Full Article

Abbvie Looking To Return Additional Cash To Shareholders
Wednesday, 10 Jan 2018 

Jan 10 (Reuters) - Abbvie Inc ::ABBVIE CEO SAYS ANTICIPATES REDUCTION IN TAX RATE AS RESULT OF US TAX REFORM.ABBVIE CEO PLANS TO MAKE SIGNIFICANT INVESTMENT IN US IN COMING YEARS WITH ACCESS TO OVERSEAS CASH.ABBVIE CEO SAYS PLANS TO ADVANCE NEUROSCIENCE PIPELINE TO CONTRIBUTE TO SALES GROWTH IN COMING DECADE.ABBVIE CEO SAYS RISANKIZUMAB FOR PSORIASIS AND RELATED INDICATIONS CAN BE $5 BILLION DRUG BY 2025.ABBVIE CEO SAYS UPADACITINIB IMMUNOLOGY DRUG CAN REACH $6.5 BILLION SALES BY 2025 WITH SIX INDICATIONS.ABBVIE SAYS EXPECTS TO MOVE AT LEAST 10 DRUGS FOR SOLID TUMOR CANCERS TO CLINICAL TRIALS IN NEXT 12 MONTHS.ABBVIE CEO SAYS WILL LOOK FOR WAYS TO RETURN ADDITIONAL CASH TO SHAREHOLDERS.  Full Article

Abbvie's Upadacitinib Granted Breakthrough Therapy Designation From FDA
Monday, 8 Jan 2018 

Jan 8 (Reuters) - Abbvie Inc ::ABBVIE'S UPADACITINIB GRANTED BREAKTHROUGH THERAPY DESIGNATION FROM THE U.S. FOOD AND DRUG ADMINISTRATION FOR ATOPIC DERMATITIS.  Full Article

AbbVie's Upadacitinib Shows Positive Results As Monotherapy In Phase 3 Rheumatoid Arthritis Study
Wednesday, 20 Dec 2017 

Dec 20 (Reuters) - AbbVie Inc ::ABBVIE'S UPADACITINIB SHOWS POSITIVE RESULTS AS MONOTHERAPY IN PHASE 3 RHEUMATOID ARTHRITIS STUDY, MEETING ALL PRIMARY AND KEY SECONDARY ENDPOINTS.ABBVIE INC - LOOK FORWARD TO SHARING ADDITIONAL DATA FROM UPADACITINIB PHASE 3 RHEUMATOID ARTHRITIS PROGRAM WITH SCIENTIFIC COMMUNITY IN 2018.  Full Article

Abbvie Says Phase 3 Study Of Venclexta/Venclyxto In Combination With Rituxan Meets Primary Endpoint
Tuesday, 12 Dec 2017 

Dec 12 (Reuters) - Abbvie Inc ::ABBVIE ANNOUNCES PHASE 3 STUDY OF VENCLEXTA™/ VENCLYXTO™ (VENETOCLAX) IN COMBINATION WITH RITUXAN® (RITUXIMAB) MEETS ITS PRIMARY ENDPOINT.ABBVIE - IN STUDY, ADVERSE EVENTS WERE CONSISTENT WITH KNOWN SAFETY PROFILE OF VENCLEXTA/VENCLYXTO AND RITUXAN.ABBVIE - GRADE 3-4 NEUTROPENIA WAS HIGHER IN VENCLEXTA/VENCLYXTO IN COMBINATION WITH RITUXAN ARM OF TRIAL.ABBVIE - FOR PATIENTS TAKING VENCLEXTA/VENCLYXTO WITH RITUXAN, THERE WERE 6 GRADE ≥3 TLS AES IN EACH ARM.ABBVIE - FOR PATIENTS TAKING BENDAMUSTINE WITH RITUXAN, THERE WERE 2 GRADE ≥3 TLS AES IN EACH ARM.ABBVIE - FOR VENCLEXTA/VENCLYXTO IN COMBINATION WITH RITUXAN, AES LEADING TO DEATH WERE SEEN IN 10 PATIENTS.ABBVIE - FOR BENDAMUSTINE IN COMBINATION WITH RITUXAN, AES LEADING TO DEATH WERE SEEN IN 11 PATIENTS.  Full Article

Imbruvica Plus Rituximab Phase 3 Innovate Trial In Rare Waldenström's Macroglobulinemia Met Primary Endpoint
Tuesday, 5 Dec 2017 

Dec 5 (Reuters) - Abbvie Inc ::IMBRUVICA® (IBRUTINIB) PLUS RITUXIMAB PHASE 3 INNOVATE TRIAL IN RARE WALDENSTRÖM'S MACROGLOBULINEMIA MET PRIMARY ENDPOINT.ABBVIE - PHARMACYCLICS, JANSSEN PLAN TO SHARE INTERIM ANALYSIS DATA FROM PHASE 3 INNOVATE STUDY WITH REGULATORY AUTHORITIES.  Full Article

AbbVie, on conf call, says we need to see HCV market sort itself out
Friday, 27 Oct 2017 

Oct 27 (Reuters) - Abbvie Inc ::AbbVie CEO, on conf call, says we need to see HCV market sort itself out.AbbVie CEO, on conf call, says psoriasis business &, in general, areas where humira competes, has been and continues to be a relatively crowded market.AbbVie CEO, on conf call, says humira will still be a workhorse product within the psoriasis market, and risankizumab will fit in.AbbVie CEO, on conf call, says we would attempt to get a preliminary injunction to block any launches that violate our Humira IP ‍​.AbbVie, on conf call, says upadacitinib NDA next year will be filed with at least five of six studies ‍​.  Full Article

Abbvie reports Q3 adjusted earnings per share $1.41
Friday, 27 Oct 2017 

Oct 27 (Reuters) - Abbvie Inc ::Abbvie says Q3 earnings per share $1.01; Q3 adjusted earnings per share $1.41; Q3 net revenue $6,995 million versus $6,432 million.Abbvie says Q3 global humira net revenue $4.70 billion, up 15.8 percent on a reported basis.Q3 earnings per share view $1.38, revenue view $7.00 billion -- Thomson Reuters I/B/E/S.Abbvie says Q3 global imbruvica net revenue $688 million, up 37.3 percent on a reported basis.Abbvie says updates 2017 earnings per share guidance range to $4.27 to $4.29; raises 2017 adjusted earnings per share guidance range to $5.53 to $5.55.FY2017 earnings per share view $5.53 -- Thomson Reuters I/B/E/S.Abbvie says provides 2018 adjusted earnings per share guidance of $6.37 to $6.57.Fy2018 earnings per share view $6.56 -- Thomson Reuters I/B/E/S.Abbvie says on track to meet/exceed long-range guidance provided in Oct 2015; now expects 2020 global Humira sales to approach $21 billion.Announces a dividend increase of 11 percent, beginning with dividend payable in February 2018.2017 adjusted earnings per share outlook excludes $1.26 per share of intangible asset amortization expense, other items.  Full Article

Abbvie increases quarterly dividend by 11 percent
Friday, 27 Oct 2017 

Oct 27 (Reuters) - Abbvie Inc ::Abbvie increases quarterly dividend by 11 percent.Abbvie increases quarterly dividend by 11 percent.Sets quarterly cash dividend of $0.71 per share.  Full Article

BRIEF-Abbvie's Upadacitinib Meets Primary And Key Efficacy Endpoints In Phase 2B/3 Rheumatoid Arthritis Study In Japanese Patients

* ABBVIE'S UPADACITINIB MEETS PRIMARY AND KEY EFFICACY ENDPOINTS IN PHASE 2B/3 RHEUMATOID ARTHRITIS STUDY IN JAPANESE PATIENTS