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Regeneron Pharmaceuticals Inc (REGN.OQ)

REGN.OQ on NASDAQ Stock Exchange Global Select Market

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14 Dec 2017
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Latest Key Developments (Source: Significant Developments)

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

Aimmune Therapeutics collaborates to study AR101 with Regeneron and Sanofi’s dupilumab for peanut allergy
Monday, 16 Oct 2017 

Oct 16 (Reuters) - Aimmune Therapeutics Inc : :Aimmune Therapeutics announces clinical collaboration to study AR101 with Regeneron and Sanofi’s dupilumab for peanut allergy.Aimmune Therapeutics Inc - ‍regeneron will sponsor trial, with Aimmune to provide clinical supply of AR101 and food challenge materials​.Aimmune Therapeutics Inc - ‍clinical collaboration will include formation of an Aimmune-Regeneron/Sanofi joint development committee​.Aimmune Therapeutics Inc - ‍planned phase 2 clinical trial to study AR101 is expected to begin in 2018​.Aimmune Therapeutics Inc - ‍trial design will test potential to achieve sustained unresponsiveness to peanut following treatment​.  Full Article

Regeneron, Sanofi announce positive Dupilumab topline results from phase 3 trial in uncontrolled persistent Asthma
Monday, 11 Sep 2017 

Sept 11 (Reuters) - Regeneron Pharmaceuticals Inc :Regeneron and Sanofi announce positive Dupilumab topline results from phase 3 trial in uncontrolled persistent Asthma.Regeneron and Sanofi announce positive Dupilumab topline results from phase 3 trial in uncontrolled persistent Asthma.Co, Sanofi announced pivotal phase 3 liberty asthma quest study of met its two primary endpoints.Results for 200 mg and 300 mg Dupilumab dose groups were generally comparable on both exacerbations and fev.Cos plan to submit a supplemental biologics license application to U.S. Food and drug administration (FDA) by end of year.  Full Article

Sanofi, Regeneron say Cemiplimab receives U.S. FDA breakthrough designation for advanced cutaneous squamous cell carcinoma
Friday, 8 Sep 2017 

Sept 8 (Reuters) - :Sanofi, Regeneron: Cemiplimab receives FDA breakthrough designation for advanced cutaneous squamous cell carcinoma.Sanofi - pending data results, co and Regeneron anticipate submitting a biologics license application for Cemiplimab with the FDA in Q1 2018.Sanofi - Cemiplimab is currently under clinical development, its safety and efficacy has not been fully evaluated by any regulatory authority.  Full Article

Regeneron and Sanofi receive complete response letter from FDA for Sarilumab
Friday, 28 Oct 2016 

Sanofi Sa : Regeneron and sanofi receive complete response letter from fda for sarilumab, an investigational treatment for rheumatoid arthritis . Sanofi says sanofi and regeneron remain committed to development of sarilumab and providing therapy to ra patients in u.s. As quickly as possible . Sanofi -if approved by fda, sarilumab would be commercialized by regeneron and sanofi genzyme, specialty care global business unit of sanofi .Sanofi - crl refers to certain deficiencies identified during gmp inspection of facility in france where sarilumab is filled and finished.  Full Article

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France's Sanofi pins hopes on new drugs after setbacks

PARIS Sanofi's promising pipeline of experimental drugs can help it overcome setbacks including the low uptake of a new cholesterol treatment and concerns about a dengue vaccine, the French pharmaceuticals group said on Wednesday.