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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)

Ziopharm Oncology Announces Immuno-Oncology Clinical Supply Agreement With Regeneron
Monday, 12 Nov 2018 

Nov 12 (Reuters) - ZIOPHARM Oncology Inc ::ZIOPHARM ONCOLOGY ANNOUNCES IMMUNO-ONCOLOGY CLINICAL SUPPLY AGREEMENT WITH REGENERON TO EVALUATE COMBINATION THERAPY FOR PATIENTS WITH BRAIN CANCER.ZIOPHARM ONCOLOGY INC - UNDER AGREEMENT ZIOPHARM AND REGENERON WILL INITIATE A PHASE 2 STUDY IN FIRST HALF OF 2019 IN PATIENTS WITH RGBM.ZIOPHARM ONCOLOGY INC - PHASE 2 STUDY TO MEASURE PRELIMINARY SAFETY AND EFFICACY OF AD-RTS-HIL-12 PLUS VELEDIMEX IN COMBINATION WITH LIBTAYO.ZIOPHARM ONCOLOGY INC - UNDER AGREEMENT ZIOPHARM WILL BE RESPONSIBLE FOR CONDUCT AND COSTS OF CLINICAL TRIAL, AND REGENERON WILL SUPPLY LIBTAYO FOR STUDY.  Full Article

Sanofi: Analyses On Mortality From ODYSSEY OUTCOMES Trial Of Praluent
Sunday, 11 Nov 2018 

Nov 12 (Reuters) - SANOFI SA ::ANNOUNCED ON SUNDAY ANALYSES ON MORTALITY FROM THE 18,924-PATIENT ODYSSEY OUTCOMES TRIAL.PRALUENT® (ALIROCUMAB) WAS ASSOCIATED WITH FEWER DEATHS IN PATIENTS WHO HAD EXPERIENCED A HEART ATTACK OR UNSTABLE ANGINA.ADDITIONAL NEW ANALYSES SHOWED AN ASSOCIATION BETWEEN REDUCED NON-FATAL CARDIOVASCULAR (CV) EVENTS AND REDUCTION IN NON-CV DEATH DURING THE TRIAL PERIOD.PRALUENT ADDED TO MAXIMALLY-TOLERATED STATINS WAS COMPARED TO MAXIMALLY-TOLERATED STATINS ALONE IN PATIENTS WHO HAD EXPERIENCED AN ACS WITHIN THE LAST 12 MONTHS.NO NEW SAFETY SIGNALS WERE FOUND IN THE ANALYSES.DATA HAVE BEEN SUBMITTED TO REGULATORY AUTHORITIES, TARGET ACTION DATE FOR FDA DECISION IS APRIL 28, 2019.  Full Article

Regeneron Says EYLEA Injection Improves Diabetic Retinopathy In Phase 3 Trial
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - Regeneron Pharmaceuticals Inc ::EYLEA (AFLIBERCEPT) INJECTION IMPROVES DIABETIC RETINOPATHY, REDUCES VISION-THREATENING COMPLICATIONS IN PHASE 3 TRIAL.CRL REQUESTED INFO ON MANUFACTURING, SUPPLY, COMPLETION OF USABILITY STUDY OF A SINGLE INJECTION OF EYLEA PRE-FILLED SYRINGE IN ABOUT 30 PATIENTS.EXPECTS TO COMPILE ALL REQUESTED INFORMATION, RESUBMIT PAS IN EARLY 2019.CONTINUES TO EXPECT 2019 LAUNCH OF EYLEA PRE-FILLED SYRINGE.FDA ISSUED CRL REGARDING CMC PRIOR-APPROVAL SUPPLEMENT FOR EYLEA PRE-FILLED SYRINGE.PHASE 3 PANORAMA TRIAL EVALUATING EYLEA INJECTION IN PATIENTS WITH MODERATELY SEVERE, SEVERE NPDR MET PRIMARY, KEY SECONDARY ENDPOINTS.EVERY 8-WEEK AND EVERY 16-WEEK DOSING GROUPS FOR EYLEA MET PRIMARY, KEY SECONDARY ENDPOINTS AT 1 YEAR.ADVERSE EVENTS WERE CONSISTENT WITH THE KNOWN PROFILE OF EYLEA.SERIOUS OCULAR TREATMENT-EMERGENT ADVERSE EVENTS IN STUDY EYE OCCURRED IN 0 & 1 PATIENTS IN EYLEA GROUPS, 1 PATIENT IN SHAM INJECTION GROUP.OCULAR INFLAMMATION OCCURRED IN 1 PATIENT IN EACH EYLEA TREATMENT GROUP AND 0 PATIENTS IN SHAM INJECTION GROUP.APTC-DEFINED ARTERIAL THROMBOEMBOLIC TREATMENT-EMERGENT EVENTS OCCURRED IN 4 & 2 PATIENTS IN EYLEA GROUPS, 5 PATIENTS IN SHAM INJECTION GROUP.  Full Article

Dupixent Shows Positive Topline Results In Two Phase 3 Trials Of Patients
Tuesday, 16 Oct 2018 

Oct 16 (Reuters) - Regeneron Pharmaceuticals Inc ::DUPIXENT® (DUPILUMAB) SHOWED POSITIVE TOPLINE RESULTS IN TWO PHASE 3 TRIALS OF PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS.DUPIXENT® (DUPILUMAB) SHOWED POSITIVE TOPLINE RESULTS IN TWO PHASE 3 TRIALS OF PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS.REGENERON PHARMACEUTICALS INC - BOTH PIVOTAL PHASE 3 PLACEBO-CONTROLLED TRIALS EVALUATING DUPIXENT MET ALL THEIR PRIMARY AND SECONDARY ENDPOINTS..REGENERON PHARMACEUTICALS INC - RATES OF ADVERSE EVENTS WERE GENERALLY SIMILAR ACROSS DUPIXENT AND PLACEBO IN TRIALS.REGENERON PHARMACEUTICALS INC - NO NEW OR UNEXPECTED SIDE EFFECTS RELATED TO DUPIXENT WERE OBSERVED IN TRIALS.  Full Article

Regeneron Pharmaceuticals Inc - FDA Approves Libtayo
Friday, 28 Sep 2018 

Sept 28 (Reuters) - Regeneron Pharmaceuticals Inc ::FDA APPROVES LIBTAYO® (CEMIPLIMAB-RWLC) AS FIRST AND ONLY TREATMENT FOR ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA.REGENERON PHARMACEUTICALS INC - U.S. LIST PRICE, OR WHOLESALE ACQUISITION COST, IS $9,100 PER THREE-WEEK TREATMENT CYCLE FOR LIBTAYO.  Full Article

FDA To Review Supplemental Biologics License Application
Wednesday, 12 Sep 2018 

Sept 12 (Reuters) - Regeneron Pharmaceuticals Inc ::FDA TO REVIEW SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR PRALUENT® (ALIROCUMAB) INJECTION AS POTENTIAL TREATMENT TO REDUCE MAJOR ADVERSE CARDIOVASCULAR EVENTS.REGENERON PHARMACEUTICALS INC - FDA SET A PRESCRIPTION DRUG USER FEE ACT (PDUFA) ACTION DATE OF APRIL 28, 2019.  Full Article

Regeneron & Bluebird Bio To Collaborate To Develop New Cell Therapies For Cancer
Monday, 6 Aug 2018 

Aug 6 (Reuters) - bluebird bio Inc ::REGENERON AND BLUEBIRD BIO ANNOUNCE COLLABORATION TO DISCOVER, DEVELOP AND COMMERCIALIZE NEW CELL THERAPIES FOR CANCER.REGENERON PHARMACEUTICALS INC - WILL ALSO MAKE A $100 MILLION INVESTMENT IN BLUEBIRD BIO COMMON STOCK AT A PRICE OF $238.10 PER SHARE.REGENERON PHARMACEUTICALS - CO, BLUEBIRD BIO SELECTED 6 INITIAL TARGETS, WILL EQUALLY SHARE COSTS OF RESEARCH AND DEVELOPMENT UP TO POINT OF SUBMITTING IND APPLICATION.  Full Article

Bluebird Bio And Regeneron Announce Collaboration To Discover, Develop And Commercialize New Cell Therapies For Cancer
Monday, 6 Aug 2018 

Aug 6 (Reuters) - bluebird bio Inc ::BLUEBIRD BIO AND REGENERON ANNOUNCE COLLABORATION TO DISCOVER, DEVELOP AND COMMERCIALIZE NEW CELL THERAPIES FOR CANCER.BLUEBIRD BIO - CO, REGENERON WILL SPECIFICALLY LEVERAGE REGENERON'S VELOCISUITE PLATFORM TECHNOLOGIES FOR DISCOVERY OF FULLY HUMAN ANTIBODIES.BLUEBIRD BIO - CO, REGENERON HAVE SELECTED 6 TARGETS & WILL EQUALLY SHARE COSTS OF RND UP TO POINT OF SUBMITTING AN INVESTIGATIONAL NEW DRUG APPLICATION.  Full Article

Regeneron Reports Q2 EPS $4.82
Thursday, 2 Aug 2018 

Aug 2 (Reuters) - Regeneron Pharmaceuticals Inc ::Q2 2018 EYLEA (AFLIBERCEPT) INJECTION U.S. NET SALES INCREASED 8 PCT TO $992 MILLION VERSUS Q2 2017.REGENERON REPORTS SECOND QUARTER 2018 FINANCIAL AND OPERATING RESULTS.Q2 GAAP EARNINGS PER SHARE $4.82.Q2 EARNINGS PER SHARE VIEW $4.70 -- THOMSON REUTERS I/B/E/S.QTRLY TOTAL REVENUES $1,608 MILLION VERSUS $1,470 MILLION.SEES 2018 CAPEX $410 MILLION TO $450 MILLION.Q2 REVENUE VIEW $1.56 BILLION -- THOMSON REUTERS I/B/E/S.QTRLY NON-GAAP NET INCOME PER SHARE $ 5.45.QTRLY TOTAL NET PRODUCT SALES RECORDED BY SANOFI FOR PRALUENT $32 MILLION.QTRLY TOTAL NET PRODUCT SALES RECORDED BY SANOFI FOR DUPIXENT $28 MILLION.  Full Article

Intellia Therapeutics, Regeneron Agreed To Co-Development Agreement
Friday, 20 Jul 2018 

July 20 (Reuters) - Intellia Therapeutics Inc ::INTELLIA THERAPEUTICS - CO, REGENERON AGREED TO CO-DEVELOPMENT/CO-PROMOTION AGREEMENT CONSISTENT WITH A CERTAIN SCHEDULE OF THEIR APRIL 2016 COLLABORATION DEAL.INTELLIA THERAPEUTICS SAYS CO, REGENERON ENTERED INTO FIRST CO-DEVELOPMENT/CO-PROMOTION AGREEMENT DIRECTED TO A TARGET, WHICH IS TRANSTHYRETIN - SEC FILING.  Full Article

J&J unit to pay $360 mln to U.S. to resolve charity kickback probe

BOSTON, Dec 6 A unit of Johnson & Johnson has agreed to pay the U.S. government $360 million to resolve an investigation into its financial support of charities that help Medicare patients cover out-of-pocket drug costs, the U.S. Justice Department said on Thursday.