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Regeneron Pharmaceuticals Inc (REGN.OQ)

REGN.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Regeneron Announces Approval Of Dupixent (Dupilumab) In Japan For Treatment Of Atopic Dermatitis
Monday, 22 Jan 2018 

Jan 22 (Reuters) - Regeneron Pharmaceuticals Inc ::REGENERON ANNOUNCES APPROVAL OF DUPIXENT® (DUPILUMAB) IN JAPAN FOR THE TREATMENT OF ATOPIC DERMATITIS.REGENERON PHARMACEUTICALS - DUPIXENT IS BEING JOINTLY DEVELOPED BY CO, SANOFI UNDER A COLLABORATION AGREEMENT, & WILL BE COMMERCIALIZED IN JAPAN BY SANOFI.  Full Article

Aimmune Therapeutics Announces 2018 Outlook, Including Upcoming Data From Pivotal Phase 3 Palisade Trial Of AR101 For Peanut Allergy
Monday, 8 Jan 2018 

Jan 8 (Reuters) - Aimmune Therapeutics Inc ::AIMMUNE THERAPEUTICS - PALISADE COMPLETED IN 2017; TOPLINE RESULTS ANTICIPATED IN FEBRUARY.AIMMUNE THERAPEUTICS INC - AR101 BLA SUBMISSION EXPECTED AT END OF 2018.AIMMUNE THERAPEUTICS ANNOUNCES 2018 OUTLOOK, INCLUDING UPCOMING DATA FROM PIVOTAL PHASE 3 PALISADE TRIAL OF AR101 FOR PEANUT ALLERGY.AIMMUNE THERAPEUTICS - ARTEMIS TRIAL IS ON TRACK TO COMPLETE ENROLLMENT IN Q1 OF 2018, EXPECTS DATA FROM ARTEMIS IN EARLY 2019.AIMMUNE THERAPEUTICS INC - ENDED 2017 WITH ABOUT $182 MILLION IN CASH, CASH EQUIVALENTS AND INVESTMENTS AS OF DEC 31, 2017.AIMMUNE THERAPEUTICS INC- 2018 PLANS INCLUDE INITIATION OF ARC005 CLINICAL TRIAL OF AR101 FOR PEANUT ALLERGY IN YOUNG CHILDREN AGES 6-48 MONTHS.AIMMUNE THERAPEUTICS - 2018 PLANS ALSO INCLUDE INITIATION, WITH REGENERON AND SANOFI, OF PHASE 2 CLINICAL TRIAL OF AR101 AND ADJUNCTIVE DUPILUMAB.AIMMUNE - ALSO EXPECTS TO FILE IND APPLICATION FOR EGG ALLERGY PROGRAM IN 2018, CONTINUE WORK TOWARD FILING IND FOR WALNUT ALLERGY IN 2019.  Full Article

Regeneron Pharma Says Enter Letter Agreement Relating To Immuno-Oncology License,Collaboration Agreement With Sanofi
Monday, 8 Jan 2018 

Jan 8 (Reuters) - Regeneron Pharmaceuticals Inc ::REGENERON PHARMACEUTICALS-ON JAN 7,ENTERED LETTER AGREEMENT RELATING TO IMMUNO-ONCOLOGY LICENSE,COLLABORATION AGREEMENT WITH SANOFI BIOTECHNOLOGY SAS​.REGENERON PHARMACEUTICALS-PURSUANT TO LETTER AGREEMENT, CO, SANOFI SAS, AGREED TO INCREASE REGN2810 BUDGET AMOUNT TO $1.640 BILLION.REGENERON -ENTERED LETTER AGREEMENT ALSO RELATING TO AMONG OTHERS​, THE INVESTOR AGREEMENT DATED AS OF JAN 11, 2014, WITH SANOFI - SEC FILING.REGENERON PHARMACEUTICALS INC - ‍ ALSO AGREED TO REVISE REGN2810 GLOBAL DEVELOPMENT PLAN AND REGN2810 GLOBAL DEVELOPMENT BUDGET.  Full Article

Regeneron And Isa Pharmaceuticals Announce Strategic Immuno-Oncology Collaboration
Monday, 18 Dec 2017 

Regeneron Pharmaceuticals Inc ::REGENERON AND ISA PHARMACEUTICALS ANNOUNCE STRATEGIC IMMUNO-ONCOLOGY COLLABORATION.‍REGENERON AND ISA WILL SHARE CLINICAL TRIAL COSTS AND EXCHANGE PRODUCT SUPPLY​.REGENERON PHARMACEUTICALS- CO AND ISA WILL JOINTLY FUND AND CONDUCT CLINICAL TRIALS OF COMBINATION TREATMENT IN CERVICAL CANCER AND HEAD-AND-NECK CANCER.SAYS FURTHER FINANCIAL DETAILS WERE NOT DISCLOSED.REGENERON PHARMACEUTICALS -‍IN ADDITION, CO WILL PROVIDE UPFRONT PAYMENT, EQUITY INVESTMENT IN EXCHANGE FOR OPTION TO EXCLUSIVE GLOBAL LICENSE FOR ISA101​.SAYS ANNOUNCED A CLINICAL COLLABORATION TO ADVANCE ISA101, AN IMMUNOTHERAPY TARGETING HPV16-INDUCED CANCER.  Full Article

Regeneron And Sanofi Announce Positive Topline Pivotal Results For Pd-1 Antibody Cemiplimab In Advanced Cutaneous Squamous Cell Carcinoma
Wednesday, 13 Dec 2017 

Regeneron Pharmaceuticals Inc ::REGENERON AND SANOFI ANNOUNCE POSITIVE TOPLINE PIVOTAL RESULTS FOR PD-1 ANTIBODY CEMIPLIMAB IN ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA.REGENERON PHARMACEUTICALS INC SAYS SAFETY PROFILE IN STUDY WAS GENERALLY CONSISTENT WITH APPROVED ANTI-PD-1 AGENTS..REGENERON PHARMACEUTICALS INC SAYS SUBMISSION TO EUROPEAN MEDICINES AGENCY (EMA) IS ALSO EXPECTED TO BE COMPLETED IN Q1 OF 2018.REGENERON PHARMACEUTICALS - ‍SUBMISSION TO U.S. FOOD AND DRUG ADMINISTRATION , WHICH HAS BEEN INITIATED AND IS EXPECTED TO BE COMPLETED IN Q1 OF 2018​.  Full Article

Regeneron Announces FDA Acceptance Of SBLA Filing For 12-Week Dosing Of Eylea(Aflibercept) Injection For Patients With Wet AMD
Monday, 11 Dec 2017 

Dec 11 (Reuters) - Regeneron Pharmaceuticals Inc ::REGENERON ANNOUNCES FDA ACCEPTANCE OF SBLA FILING FOR 12-WEEK DOSING OF EYLEA® (AFLIBERCEPT) INJECTION FOR PATIENTS WITH WET AMD.REGENERON PHARMACEUTICALS - UNDER PDUFA, GOAL FOR STANDARD REVIEW OF AN SBLA IS TEN MONTHS FROM SUBMISSION FOR A TARGET ACTION DATE OF AUGUST 11, 2018.  Full Article

Regeneron And Decibel Therapeutics Announce Strategic Collaboration
Wednesday, 29 Nov 2017 

Nov 29 (Reuters) - Regeneron Pharmaceuticals Inc ::REGENERON AND DECIBEL THERAPEUTICS ANNOUNCE STRATEGIC COLLABORATION TO DISCOVER AND DEVELOP THERAPEUTICS FOR HEARING LOSS AND TINNITUS.REGENERON PHARMACEUTICALS INC - ‍FURTHER FINANCIAL TERMS WERE NOT DISCLOSED​.REGENERON PHARMACEUTICALS INC - WILL PROVIDE DECIBEL WITH BROAD ACCESS TO ITS PROPRIETARY SUITE OF TECHNOLOGIES​.REGENERON PHARMACEUTICALS INC - ‍WILL ALSO DIRECTLY PARTICIPATE IN AND PROVIDE FINANCIAL SUPPORT FOR DECIBEL'S RESEARCH AND DEVELOPMENT EFFORTS​.REGENERON PHARMACEUTICALS INC - ‍DECIBEL RETAINS WORLDWIDE DEVELOPMENT AND COMMERCIALIZATION RIGHTS TO ANY PRODUCTS DISCOVERED IN COLLABORATION​.REGENERON PHARMACEUTICALS INC - ‍DECIBEL WILL PAY REGENERON TIERED ROYALTIES BASED ON NET SALES​.  Full Article

Regeneron Provides Update On Eylea (Aflibercept) Injection And Nesvacumab (Ang2 Antibody) Combination Program
Monday, 27 Nov 2017 

Nov 27 (Reuters) - Regeneron Pharmaceuticals Inc ::REGENERON PROVIDES UPDATE ON EYLEA® (AFLIBERCEPT) INJECTION AND NESVACUMAB (ANG2 ANTIBODY) COMBINATION PROGRAM.REGENERON PHARMACEUTICALS INC -‍ RESULTS FROM TWO PHASE 2 STUDIES DID NOT PROVIDE SUFFICIENT DIFFERENTIATION TO WARRANT PHASE 3 DEVELOPMENT​.REGENERON PHARMACEUTICALS - ‍RESULTS FROM RUBY, ONYX WILL BE FURTHER ANALYZED AND WILL BE SUBMITTED FOR PRESENTATION AT A FUTURE MEDICAL CONGRESS​.REGENERON PHARMACEUTICALS - ‍EYLEA RESULTS CONSISTENT WITH FINDINGS IN PREVIOUS CLINICAL STUDIES; THERE WERE NO NEW SAFETY SIGNALS IN THESE STUDIES​.  Full Article

Regeneron Q3 non-GAAP earnings per share $3.99
Wednesday, 8 Nov 2017 

Nov 8 (Reuters) - Regeneron Pharmaceuticals Inc :Regeneron reports third quarter 2017 financial and operating results.Q3 non-GAAP earnings per share $3.99.Q3 GAAP earnings per share $3.32.Q3 earnings per share view $3.85 -- Thomson Reuters I/B/E/S.Regeneron Pharmaceuticals Inc - qtrly total revenue $ ‍1,501​ million versus $1,220 million.Regeneron Pharmaceuticals Inc - qtrly EYLEA U.S. net product sales $‍953​ million versus $854 million.Regeneron Pharmaceuticals - qtrly global net sales of dupixent were $89 million, which were almost exclusively in United States​.Regeneron Pharmaceuticals Inc sees FY2017 ‍EYLEA U.S. net product sales approximately 10% growth over 2016​.Regeneron Pharmaceuticals - ‍expect to submit first regulatory application for Cemiplimab in advanced cutaneous squamous cell carcinoma in early 2018​.Regeneron Pharmaceuticals Inc sees FY2017 ‍capital expenditures to be between $265 million and $285 million​.Q3 revenue view $1.46 billion -- Thomson Reuters I/B/E/S.Regeneron Pharmaceuticals Inc - qtrly ‍global net sales of praluent were $49 million, compared to $38 million in Q3 2016​.Regeneron Pharmaceuticals - ‍qtrly revenue include Sanofi and Bayer collaboration revenue of $482 million.Regeneron Pharmaceuticals Inc sees 2017 ‍Sanofi reimbursement of Regeneron commercialization-related expenses​ in a range of $350 million - $375 million.  Full Article

Regeneron and Sanofi to present new analyses from Praluent injection Odyssey clinical trial
Tuesday, 7 Nov 2017 

Nov 7 (Reuters) - Regeneron Pharmaceuticals Inc :Regeneron and Sanofi to present new analyses from the Praluent® (alirocumab) injection Odyssey clinical trial program at the AHA Scientific Sessions 2017.  Full Article

Regeneron CEO says fears over Eylea 'greatly exaggerated'

Fears of the demise of blockbuster eye drug Eylea were "greatly exaggerated," Regeneron Pharmaceuticals Inc's chief executive said on Thursday, after the treatment and new eczema drug Dupixent powered the company's fourth-quarter results.