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Novartis AG (NVS.N)

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Latest Key Developments (Source: Significant Developments)

Novartis: Kisqali Shown To Prolong Life In Women With Breast Cancer
Wednesday, 31 Jul 2019 10:05am EDT 

July 31 (Reuters) - Novartis AG ::NOVARTIS KISQALI SIGNIFICANTLY PROLONGS LIFE IN WOMEN WITH HR+/HER2- ADVANCED BREAST CANCER NOW IN TWO DISTINCT PHASE III TRIALS.IN MONALEESA-3, KISQALI PLUS FULVESTRANT ACHIEVED STATISTICALLY SIGNIFICANT IMPROVEMENT IN OVERALL SURVIVAL IN POST-MENOPAUSAL WOMEN IN FIRST- AND SECOND-LINE SETTING.  Full Article

Novartis Gives Update On Phase III PARAGON-HF Trial In Heart Failure Patients
Monday, 29 Jul 2019 01:00am EDT 

July 29 (Reuters) - Novartis Ag ::NOVARTIS PROVIDES UPDATE ON PHASE III PARAGON-HF TRIAL IN HEART FAILURE PATIENTS WITH PRESERVED EJECTION FRACTION (HFPEF).PARAGON STUDY NARROWLY MISSES STATISTICAL SIGNIFICANCE ON PRIMARY ENDPOINT; OVERALL SAFETY PROFILE CONFIRMED.TOTALITY OF EVIDENCE SUGGESTS POTENTIAL CLINICALLY IMPORTANT BENEFIT; RESULTS WILL BE PRESENTED IN SEPTEMBER AT ESC CONGRESS 2019.  Full Article

Novartis CEO Says U.S. Gov't Policy Environment Very Fluid
Thursday, 18 Jul 2019 09:01am EDT 

July 18 (Reuters) - Novartis AG ::NOVARTIS CEO SAYS PLANS TO INITIATE DISCUSSIONS WITH FDA OVER INTRATHECAL ADMINISTRATION OF ZOLGENSMA LATER THIS YEAR.NOVARTIS CFO SAYS PROFITABILITY BENEFITED IN H1 FROM VALSARTAN SUPPLY SHORTAGE.NOVARTIS CEO SAYS U.S. GOVERNMENT POLICY ENVIRONMENT "VERY FLUID" REGARDING DRUG PRICING AFTER TRUMP ADMINISTRATION DROPS REBATE RULE.NOVARTIS DRUG DIVISION CHIEF SAYS CONFIDENT ABOUT MS DRUG MAYZENT'S LONGTERM POTENTIAL, BUT SAYS 'THIS YEAR IS ALL ABOUT EDUCATION" AND IDENTIFYING PATIENTS.  Full Article

Novartis CEO Expects Q4 European Commission Approval For Zolgensma
Thursday, 18 Jul 2019 09:00am EDT 

July 18 (Reuters) - Novartis AG ::NOVARTIS CEO SAYS EXPECTS Q4 EUROPEAN COMMISSION APPROVAL FOR ZOLGENSMA.  Full Article

Lifemax Laboratories Says FDA Granted Rare Pediatric Disease Designation To Lm-030
Thursday, 18 Jul 2019 07:00am EDT 

July 18 (Reuters) - Novartis AG ::LIFEMAX LABORATORIES - FDA GRANTED RARE PEDIATRIC DISEASE DESIGNATION TO LM-030, AN INVESTIGATIONAL THERAPY LICENSED FROM NOVARTIS.  Full Article

Recordati To Acquire Worldwide Rights To Signifor And Osilodrostat (LCI699)
Friday, 12 Jul 2019 02:30pm EDT 

July 12 (Reuters) - Recordati Industria Chimica e Farmaceutica SpA ::RECORDATI TO ACQUIRE WORLDWIDE RIGHTS TO SIGNIFOR® AND OSILODROSTAT (LCI699).RECORDATI - ANNOUNCES SIGNING OF AN AGREEMENT WITH NOVARTIS FOR ACQUISITION OF WORLDWIDE RIGHTS TO SIGNIFOR AND SIGNIFOR LAR.RECORDATI - AGREEMENT ALSO COVERS ACQUISITION OF WORLDWIDE RIGHTS TO OSILODROSTAT (LCI699).RECORDATI - UPON COMPLETION OF TRANSACTION A CONSIDERATION OF $390 MILLION WILL BE DUE TO NOVARTIS.RECORDATI - UNDER TERMS OF AGREEMENT NOVARTIS WILL SUPPLY SIGNIFOR AND OSILODROSTAT (LCI699) PRODUCTS TO RECORDATI FOR A TRANSITIONAL PERIOD.  Full Article

Amphastar Pharmaceuticals Announces Settlement In Litigation With Momenta And Sandoz
Wednesday, 19 Jun 2019 06:00am EDT 

June 19 (Reuters) - Amphastar Pharmaceuticals Inc ::AMPHASTAR PHARMACEUTICALS, INC. ANNOUNCES SETTLEMENT IN LITIGATION WITH MOMENTA AND SANDOZ.AMPHASTAR PHARMACEUTICALS - MOMENTA/SANDOZ WILL PAY CO $59.9 MILLION NO LATER THAN JULY 2.AMPHASTAR PHARMACEUTICALS INC - CO, MOMENTA/SANDOZ WILL SUBMIT STIPULATIONS OF DISMISSAL OF ALL PENDING LITIGATION BETWEEN PARTIES..  Full Article

Atara Biotherapeutics Appoints Pascal Touchon As Chief Executive Officer
Tuesday, 28 May 2019 05:00pm EDT 

May 28 (Reuters) - Atara Biotherapeutics Inc ::ATARA BIOTHERAPEUTICS APPOINTS PASCAL TOUCHON PRESIDENT, CHIEF EXECUTIVE OFFICER AND MEMBER OF THE BOARD OF DIRECTORS.ATARA BIOTHERAPEUTICS INC - TOUCHON WAS MOST RECENTLY AT NOVARTIS ONCOLOGY AS GLOBAL HEAD, CELL & GENE AND MEMBER OF ONCOLOGY EXECUTIVE COMMITTEE.ATARA BIOTHERAPEUTICS INC - ISAAC CIECHANOVER STEPPED DOWN FROM HIS ROLE AS PRESIDENT, CHIEF EXECUTIVE OFFICER.ATARA BIOTHERAPEUTICS INC - DIETMAR BERGER, ATARA'S GLOBAL HEAD OF RESEARCH AND DEVELOPMENT, HAS RESIGNED.  Full Article

FDA Approves Jakafi For The Treatment Of Patients With Acute Graft-Versus-Host Disease
Friday, 24 May 2019 01:43pm EDT 

May 24 (Reuters) - Incyte Corp ::FDA APPROVES JAKAFI® (RUXOLITINIB) FOR THE TREATMENT OF PATIENTS WITH ACUTE GRAFT-VERSUS-HOST DISEASE.INCYTE CORP - JAKAFI WILL BE MADE AVAILABLE TO APPROPRIATE PATIENTS WITH STEROID-REFRACTORY ACUTE GVHD IMMEDIATELY..INCYTE CORP - FDA APPROVED JAKAFI (RUXOLITINIB) FOR TREATMENT OF STEROID-REFRACTORY ACUTE GVHD IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER.  Full Article

Regenxbio Announces First FDA Approval Of A Gene Therapy Based On Its Proprietary Nav Technology Platform
Friday, 24 May 2019 01:14pm EDT 

May 24 (Reuters) - Regenxbio Inc ::REGENXBIO ANNOUNCES FIRST FDA APPROVAL OF A GENE THERAPY BASED ON ITS PROPRIETARY NAV® TECHNOLOGY PLATFORM.REGENXBIO INC - ADDITIONAL APPROVALS FOR GENE THERAPY BASED ON ITS PROPRIETARY NAV® TECHNOLOGY PLATFORM ANTICIPATED IN EUROPE AND JAPAN IN 2019.  Full Article

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Novartis to answer U.S. Senate demand for data manipulation details

ZURICH Novartis plans to answer a U.S. senator who demanded details about data manipulation related to its gene therapy Zolgensma, amid scrutiny of the Swiss drugmaker's decision to delay informing regulators until after the treatment's approval.