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Biogen Inc (BIIB.OQ)

BIIB.OQ on NASDAQ Stock Exchange Global Select Market

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15 Jan 2019
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Latest Key Developments (Source: Significant Developments)

Banner Gets FDA Tentative Approval For Multiple Sclerosis Treatment Bafiertam
Wednesday, 2 Jan 2019 

Jan 2 (Reuters) - Biogen Inc ::BANNER RECEIVES FDA TENTATIVE APPROVAL FOR BAFIERTAM FOR THE TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS.BANNER LIFE SCIENCES LLC SAYS FULL APPROVAL EXPECTED NO LATER THAN JUNE 20, 2020.  Full Article

Alkermes And Biogen Announce Submission Of A New Drug Application To FDA For Diroximel Fumarate In Multiple Sclerosis
Monday, 17 Dec 2018 

Dec 17 (Reuters) - Biogen Inc ::ALKERMES AND BIOGEN ANNOUNCE SUBMISSION OF A NEW DRUG APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR DIROXIMEL FUMARATE IN MULTIPLE SCLEROSIS.BIOGEN INC - IF APPROVED, BIOGEN INTENDS TO MARKET DIROXIMEL FUMARATE UNDER BRAND NAME VUMERITY™.BIOGEN INC - VUMERITY™ NAME HAS BEEN CONDITIONALLY ACCEPTED BY FDA & WILL BE CONFIRMED UPON APPROVAL.  Full Article

AGTC Reports Topline Interim 6 Month Data From Phase 1/2 X-Linked Retinoschisis Clinical Study
Wednesday, 12 Dec 2018 

Dec 12 (Reuters) - Applied Genetic Technologies Corp ::AGTC ANNOUNCES TOPLINE INTERIM SIX-MONTH DATA FROM PHASE 1/2 X-LINKED RETINOSCHISIS CLINICAL STUDY; TERMINATION OF BIOGEN COLLABORATION.APPLIED GENETIC- RESULTS FROM STUDY SHOW RAAV2TYF-CB-HRS1 GENERALLY SAFE, WELL-TOLERATED, BUT NO SIGNS OF CLINICAL ACTIVITY WERE OBSERVED AT 6-MONTHS.APPLIED GENETIC TECHNOLOGIES - TO REGAIN RIGHTS TO FIVE CLINICAL AND PRECLINICAL DEVELOPMENT PROGRAMS; BIOGEN TERMINATES COLLABORATION AGREEMENT.APPLIED GENETIC TECHNOLOGIES - TO REGAIN RIGHTS TO FIVE CLINICAL & PRECLINICAL DEVELOPMENT PROGRAMS; BIOGEN TERMINATES COLLABORATION AGREEMENT.APPLIED GENETIC - ON SCHEDULE TO ADVANCE ITS PHASE 1/2 CLINICAL STUDIES IN ACHROMATOPSIA,X-LINKED RETINITIS PIGMENTOSA; 3 DATA RELEASES SEEN IN 2019.APPLIED GENETIC TECHNOLOGIES CORP - BIOGEN'S TERMINATION OF COLLABORATION AGREEMENT WILL BE EFFECTIVE ON MARCH 8, 2019.APPLIED GENETIC TECHNOLOGIES - WILL DETERMINE NEXT STEPS FOR THREE DISCOVERY PROGRAMS OVER NEXT SEVERAL MONTHS.APPLIED GENETIC TECHNOLOGIES - PREVIOUS FINANCIAL GUIDANCE, EVEN IN LIGHT OF BIOGEN'S TERMINATION OF COLLABORATION AGREEMENT, REMAINS UNCHANGED.APPLIED GENETIC TECHNOLOGIES CORP - AS OF SEPT 30, 2018, CO'S CASH, CASH EQUIVALENTS AND INVESTMENTS TOTALED $105.4 MILLION.APPLIED GENETIC TECHNOLOGIES - EXPECTS TOTAL CASH, CASH EQUIVALENTS AND INVESTMENTS AS OF JUNE 30, 2019, TO BE BETWEEN $65 AND $75 MILLION.  Full Article

HitGen And Biogen Enter Research Collaboration
Wednesday, 21 Nov 2018 

Nov 21 (Reuters) - Biogen Inc ::HITGEN AND BIOGEN ENTER A DNA-ENCODED LIBRARY-BASED DRUG DISCOVERY RESEARCH COLLABORATION.HITGEN - SPECIFIC FINANCIAL DETAILS WERE NOT DISCLOSED.HITGEN - WILL RECEIVE UPFRONT PAYMENTS, AND BE ELIGIBLE FOR MILESTONE PAYMENTS.  Full Article

Eisai And Biogen Announce Additional Data From The Phase II Clinical Trial Of Ban2401
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - Biogen Inc ::EISAI AND BIOGEN ANNOUNCE PRESENTATION OF ADDITIONAL DATA FROM THE PHASE II CLINICAL TRIAL OF BAN2401 IN EARLY ALZHEIMER’S DISEASE AT THE 2018 CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE.EISAI AND BIOGEN ANNOUNCE PRESENTATION OF ADDITIONAL DATA FROM THE PHASE II CLINICAL TRIAL OF BAN2401 IN EARLY ALZHEIMER’S DISEASE AT THE 2018 CLINICAL TRIALS ON ALZHEIMER’S DISEASE (CTAD) CONFERENCE.BIOGEN INC - BAN2401 DEMONSTRATED AN ACCEPTABLE TOLERABILITY PROFILE THROUGH 18 MONTHS OF STUDY DRUG ADMINISTRATION.BIOGEN INC - EISAI AND BIOGEN ARE CURRENTLY DISCUSSING NEXT STEPS FOR BAN2401 WITH REGULATORY AUTHORITIES.BIOGEN INC - AN OPEN-LABEL EXTENSION FOR PATIENTS PREVIOUSLY ENROLLED IN STUDY 201 IS BEING PLANNED, WITH ENROLLMENT EXPECTED TO BEGIN THIS YEAR.BIOGEN - HIGHEST TREATMENT DOSE SHOWED STATISTICALLY SIGNIFICANT SLOWING OF CLINICAL DECLINE ON ADCOMS OF 30 PERCENT VERSUS PLACEBO AT 18 MONTHS.BIOGEN - FROM CONVENTIONAL ANALYSIS, HIGHEST TREATMENT DOSE DEMONSTRATED STATISTICALLY SIGNIFICANT REDUCTION IN BRAIN AMYLOID AT 18 MONTHS (P<0.0001).BIOGEN INC - BAN2401 DEMONSTRATED AN ACCEPTABLE TOLERABILITY PROFILE THROUGH 18 MONTHS OF STUDY DRUG ADMINISTRATION.  Full Article

UCB Phase 2B Study Of DZP In SLE: Primary Endpoint Not Met
Tuesday, 23 Oct 2018 

Oct 23 (Reuters) - UCB SA ::TOPLINE RESULTS FROM A PHASE 2B STUDY OF DAPIROLIZUMAB PEGOL IN SLE.PRIMARY ENDPOINT OF THE STUDY WAS NOT MET.STUDY DID DEMONSTRATE CONSISTENT AND POTENTIALLY MEANINGFUL IMPROVEMENTS FOR THE MAJORITY OF CLINICAL ENDPOINTS IN PATIENTS TREATED WITH DZP COMPARED WITH PLACEBO.DZP WAS WELL TOLERATED AND DEMONSTRATED AN ACCEPTABLE SAFETY PROFILE..BIOMARKER DATA DEMONSTRATED EVIDENCE OF PROOF OF BIOLOGY..  Full Article

Biogen Canada And pCPA Reach Agreement On Access To Treatment For Spinal Muscular Atrophy
Wednesday, 3 Oct 2018 

Oct 3 (Reuters) - Biogen Inc ::BIOGEN CANADA AND PAN-CANADIAN PHARMACEUTICAL ALLIANCE (PCPA) REACH AGREEMENT ON ACCESS TO FIRST AND ONLY APPROVED TREATMENT FOR SPINAL MUSCULAR ATROPHY (SMA) IN CANADA.BIOGEN CANADA - PUBLIC DRUG PLANS WILL COVER TYPE 1 PATIENTS AND BIOGEN WILL COVER MOST URGENT TYPE 2 AND 3 PATIENTS UNDER AN URGENT ACCESS PROGRAM.BIOGEN CANADA - REACHED AGREEMENT WITH PAN-CANADIAN PHARMACEUTICAL ALLIANCE TO PROVIDE SMA TYPE 1 PATIENTS WITH ACCESS TO BIOGEN'S PRODUCT, SPINRAZA.  Full Article

Biogen Inc To Repurchase Up To $3.5 Bln Of Company's Common Stock
Friday, 3 Aug 2018 

Aug 3 (Reuters) - Biogen Inc ::BIOGEN INC - DIRECTORS AUTHORIZED A PROGRAM TO REPURCHASE UP TO $3.5 BILLION OF THE COMPANY’S COMMON STOCK.BIOGEN INC SAYS 2018 SHARE REPURCHASE PROGRAM DOES NOT HAVE AN EXPIRATION DATE - SEC FILING.BIOGEN INC - ALL SHARE REPURCHASES UNDER 2018 SHARE REPURCHASE PROGRAM WILL BE RETIRED.  Full Article

Biogen Reports Qtrly Non-GAAP Earnings Per Share Of $5.80
Tuesday, 24 Jul 2018 

July 24 (Reuters) - Biogen Inc ::BIOGEN Q2 2018 REVENUES INCREASE 9% TO $3.4 BILLION.QTRLY EARNINGS PER SHARE (EPS) ATTRIBUTABLE TO BIOGEN INC. $4.18.QTRLY NON-GAAP EARNINGS PER SHARE $5.80.Q2 EARNINGS PER SHARE VIEW $5.21, REVENUE VIEW $3.25 BILLION -- THOMSON REUTERS I/B/E/S.IN Q2 GAAP DILUTED EPS IMPACTED BY $2.84 RELATED TO COLLABORATION AGREEMENT WITH IONIS PHARMACEUTICALS, AMONG OTHERS.QTRLY TECFIDERA REVENUE $1,087 MILLION VERSUS $1,111 MILLION.ACQUIRES MUSCLE ENHANCEMENT PROGRAM FROM ALIVEGEN.QTRLY SPINRAZA REVENUE $423 MILLION VERSUS $203 MILLION.ACQUISITION FROM ALIVEGEN INCLUDES AN UPFRONT PAYMENT OF $27.5 MILLION.UPDATING ITS FULL YEAR 2018 FINANCIAL GUIDANCE.2018 REVENUE EXPECTED TO BE ABOUT $13.0 BILLION TO $13.2 BILLION.BIOGEN - AS PER DEAL, MAY PAY ALIVEGEN UP TO $535 MILLION IN ADDITIONAL POTENTIAL DEVELOPMENT, COMMERCIALIZATION MILESTONES ACROSS BOTH ASSETS & MULTIPLE INDICATIONS.2018 GAAP DILUTED EPS IS EXPECTED TO BE BETWEEN $21.80 AND $22.40.2018 NON-GAAP DILUTED EPS IS EXPECTED TO BE BETWEEN $24.90 AND $25.50.FY2018 EARNINGS PER SHARE VIEW $23.97, REVENUE VIEW $12.97 BILLION -- THOMSON REUTERS I/B/E/S.HAS ACQUIRED ALG-801 (PHASE 1A) AND ALG-802 (PRECLINICAL) FROM ALIVEGEN INC.  Full Article

Biogen Exercises Option To Increase Ownership In Samsung Bioepis
Thursday, 28 Jun 2018 

June 28 (Reuters) - Biogen Inc ::BIOGEN EXERCISES OPTION TO INCREASE OWNERSHIP IN SAMSUNG BIOEPIS.BIOGEN INC - WILL PAY SAMSUNG BIOLOGICS APPROXIMATELY $700 MILLION TO INCREASE ITS OWNERSHIP IN SAMSUNG BIOEPIS TO APPROXIMATELY 49.9%.BIOGEN INC - DEAL INCREASING BIOGEN'S OWNERSHIP IN SAMSUNG BIOEPIS FROM APPROXIMATELY 5.4% TO APPROXIMATELY 49.9%.  Full Article

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Best U.S. fund managers of '18 buying healthcare, pot stocks as market wobbles

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