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Novartis AG (NVS.N)

NVS.N on New York Stock Exchange

92.07USD
6 Dec 2019
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Latest Key Developments (Source: Significant Developments)

Novartis To Acquire The Medicines Company For $9.7 bln
Monday, 25 Nov 2019 

Nov 24 (Reuters) - Novartis Ag ::REG-NOVARTIS TO ACQUIRE THE MEDICINES COMPANY FOR USD 9.7 BN, ADDING INCLISIRAN, A POTENTIALLY TRANSFORMATIONAL INVESTIGATIONAL CHOLESTEROL-LOWERING THERAPY TO ADDRESS LEADING GLOBAL CAUSE OF DEATH.OFFER PRICE OF USD 85.00 PER SHARE.NOVARTIS - DEAL EXPECTED TO MODESTLY DILUTE CORE EPS VERSUS A NO DEAL SCENARIO DURING NEXT FEW YEARS AS CO INVESTS FOR A SUCCESSFUL LAUNCH OF INCLISIRAN.TRANSACTION HAS BEEN UNANIMOUSLY APPROVED BY BOARDS OF DIRECTORS OF BOTH COMPANIES.NOVARTIS PLANS TO FINANCE TRANSACTION THROUGH AVAILABLE CASH AND SHORT- AND LONG-TERM BORROWINGS.TRANSACTION IS EXPECTED TO CLOSE IN Q1 OF 2020, SUBJECT TO SATISFACTION OR WAIVER OF ALL CLOSING CONDITIONS.NOVARTIS - EXPECTS DEAL TO BE SIGNIFICANTLY ACCRETIVE TO GROUP CORE OPERATING INCOME AND CORE EPS IN MEDIUM TERM.ASSUMING COMPLETION IN Q1 OF 2020, CO EXPECTS INCLISIRAN TO START TO CONTRIBUTE TO GROUP AND IM DIVISION SALES FROM 2021.  Full Article

FDA Says Approves Novartis' Sickle Cell Disease Treatment Adakveo 100 Mg/10 Ml Injection
Saturday, 16 Nov 2019 

Nov 15 (Reuters) - U.S. FDA::FDA SAYS APPROVES NOVARTIS' SICKLE CELL DISEASE TREATMENT ADAKVEO 100 MG/10 ML INJECTION.  Full Article

Novartis Says New Medicine Adakveo® (Crizanlizumab) Approved By FDA
Saturday, 16 Nov 2019 

Nov 16 (Reuters) - Novartis AG ::REG-NEW NOVARTIS MEDICINE ADAKVEO® (CRIZANLIZUMAB) APPROVED BY FDA TO REDUCE FREQUENCY OF PAIN CRISES IN INDIVIDUALS LIVING WITH SICKLE CELL DISEASE.MEDICINE IS EXPECTED TO BE AVAILABLE TO PATIENTS IN COMING WEEKS.  Full Article

Vectura Says UK Court Dismissed GSK's Claims Of Passing Off In Respect Of Sandoz's Airflusal Forspiro
Friday, 4 Oct 2019 

Oct 4 (Reuters) - Vectura Group PLC ::VECTURA GROUP PLC - UK COURT RULING IN GSK V SANDOZ PASSING OFF CASE.VECTURA GROUP PLC - ENGLISH HIGH COURT HAS DISMISSED ALL OF GSK'S CLAIMS OF PASSING OFF IN RESPECT OF SANDOZ'S AIRFLUSAL FORSPIRO.  Full Article

Novartis Says Phase III PREVENT Study Met Primary Endpoint For Patients With Axial Spondyloarthritis
Tuesday, 17 Sep 2019 

Sept 17 (Reuters) - Novartis AG ::NOVARTIS COSENTYX® POSITIVE 16-WEEK PREVENT RESULTS ADVANCE POTENTIAL NEW INDICATION FOR PATIENTS WITH AXIAL SPONDYLOARTHRITIS.PHASE III PREVENT STUDY MET 16-WEEK PRIMARY ENDPOINT OF ASAS40 IN PATIENTS WITH ACTIVE NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS (NR-AXSPA).ALL SECONDARY ENDPOINTS WERE ALSO MET.NOVARTIS HAS SUBMITTED TO EMA FOR APPROVAL IN NR-AXSPA, WHICH WOULD BE FOURTH INDICATION FOR COSENTYX.52-WEEK DATA FROM PREVENT STUDY, TO SUPPORT FDA SUBMISSION, ARE EXPECTED LATER IN YEAR.  Full Article

Amplyx Pharmaceuticals Executed Exclusive Worldwide License Agreement With Novartis
Monday, 16 Sep 2019 

Sept 16 (Reuters) - Novartis AG ::AMPLYX PHARMACEUTICALS - EXECUTED EXCLUSIVE WORLDWIDE LICENSE AGREEMENT WITH NOVARTIS.AMPLYX PHARMACEUTICAL - UNDER AGREEMENT CO ACQUIRED RIGHTS TO PHASE 2 ANTI-BK VIRUS MONOCLONAL ANTIBODY, MAU868, FOR TREATMENT, PREVENTION OF BKV DISEASE.AMPLYX PHARMACEUTICALS - FINANCIAL TERMS HAVE NOT BEEN DISCLOSED.  Full Article

Novartis Says Data Shows Mayzent Can Help Patients With Secondary Progressive Sclerosis
Thursday, 12 Sep 2019 

Sept 12 (Reuters) - Novartis AG ::NEW NOVARTIS DATA SHOW MAYZENT® CAN HELP PRESERVE MOBILITY FOR LONGER IN PATIENTS WITH SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS (SPMS).NEW POST HOC STATISTICAL ANALYSIS OF PIVOTAL EXPAND STUDY AT ECTRIMS SHOWS THAT MAYZENT® (SIPONIMOD) CAN HELP PATIENTS KEEP THEIR MOBILITY FOR OVER FOUR YEARS LONGER ON AVERAGE.FURTHER EXPAND ANALYSES DEMONSTRATE MAYZENT ALSO SIGNIFICANTLY REDUCED GREY MATTER VOLUME LOSS AT ONE AND TWO YEARS, A KEY DRIVER OF DISABILITY PROGRESSION AND COGNITIVE DECLINE IN PATIENTS WITH SPMS.ADDITIONAL PRE-CLINICAL DATA SHOW MAYZENT MAY HAVE RE-MYELINATION PROPERTIES, WHICH SUPPORT REGENERATION OF DAMAGED MYELIN IN CENTRAL NERVOUS SYSTEM, POTENTIALLY PREVENTING FURTHER NEURODEGENERATION.MAYZENT, ONLY TREATMENT FOR ACTIVE SPMS APPROVED BY US FOOD AND DRUG ADMINISTRATION (FDA) WITH PROVEN EFFICACY IN A PIVOTAL STUDY OF A REPRESENTATIVE SPMS POPULATION, IS CURRENTLY UNDER REVIEW BY EUROPEAN MEDICINES AGENCY (EMA).  Full Article

Polpharma Biologics Announces Global Commercialization Deal For Biosimilar Natalizumab
Tuesday, 3 Sep 2019 

Sept 3 (Reuters) - Polpharma Biologics: :POLPHARMA BIOLOGICS ANNOUNCES GLOBAL COMMERCIALIZATION DEAL FOR BIOSIMILAR NATALIZUMAB.HAS ENTERED A GLOBAL COMMERCIALIZATION AGREEMENT WITH SANDOZ AG FOR A NATALIZUMAB BIOSIMILAR.MEDICINE IS CURRENTLY IN PHASE III CLINICAL DEVELOPMENT FOR TREATMENT OF RELAPSING-REMITTING MULTIPLE SCLEROSIS.UNDER AGREEMENT, CO WILL BE RESPONSIBLE FOR DEVELOPMENT, MANUFACTURING, SUPPLY OF COLLABORATION BIOSIMILAR.  Full Article

U.S. Senator Grassley Asks Novartis For Information About 'Intentional Withholding' Of Information About Zolgensma From FDA - Letter
Tuesday, 13 Aug 2019 

Aug 12 (Reuters) - :U.S. SENATOR GRASSLEY IN AUG 9 LETTER TO NOVARTIS ASKS FOR INFORMATION ABOUT 'INTENTIONAL WITHHOLDING' OF INFORMATION ABOUT ZOLGENSMA FROM U.S. FDA - LETTER.U.S. SENATOR GRASSLEY IN LETTER TO NOVARTIS CEO ASKS INFORMATION ABOUT ZOLGENSMA TO BE PROVIDED BY AUG 23, 2019 - LETTER.  Full Article

Sandoz Will Appeal District Court Of New Jersey Ruling In Biosimilar Erelzi U.S. Patent Case
Saturday, 10 Aug 2019 

Aug 9 (Reuters) - Novartis AG::SANDOZ WILL APPEAL DISTRICT COURT OF NEW JERSEY RULING IN BIOSIMILAR ERELZI® (ETANERCEPT-SZZS) US PATENT CASE.SANDOZ TO APPEAL COURT RULING TO UNITED STATES COURT OF APPEALS FOR FEDERAL CIRCUIT.FRIDAY RULING PREVENTS LAUNCH OF IMPORTANT, AFFORDABLE TREATMENT OPTION FOR US PATIENTS AFFECTED BY CHRONIC AUTOIMMUNE AND INFLAMMATORY DISEASES.SANDOZ REMAINS COMMITTED TO PROVIDING ERELZ AS SOON AS POSSIBLE.US DISTRICT COURT OF NEW JERSEY RULED AGAINST SANDOZ IN PATENT LITIGATION CONCERNING SANDOZ BIOSIMILAR, ERELZI FOR REFERENCE MEDICINE ENBREL.SANDOZ WILL APPEAL RULING TO US COURT OF APPEALS FOR FEDERAL CIRCUIT, AND PARTIES HAVE AGREED TO AN EXPEDITED APPEAL..  Full Article

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U.S. FDA approves generic versions of Novartis blockbuster MS treatment

The U.S. Food and Drug Administration on Thursday approved three generic versions of Swiss drugmaker Novartis AG's top-selling multiple sclerosis (MS) medicine Gilenya.