Novartis

Novartis AG is a holding company, which engages in the development, manufacture, and marketing of healthcare products. It operates through the following segments: Innovative Medicines, Sandoz, and Corporate. The Innovative Medicines segment researches, develops, manufactures, distributes and sells patented pharmaceuticals, and is composed of two business units: Novartis Oncology and Novartis Pharmaceuticals. The Sandoz segment develops, manufactures and markets finished dosage form medicines as well as intermediary products, including active pharmaceutical ingredients. The Corporate segment refers to group management and central services. The company was founded on February 29, 1996 and is headquartered in Basel, Switzerland.

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Novartis AG is a holding company, which engages in the business of developing, manufacturing, and marketing healthcare products. It operates through the following segments: Innovative Medicines, Sandoz, and Corporate. The Innovative Medicines segment includes researching, distributing and selling patented pharmaceuticals. The Sandoz segment focuses on marketing finished dosage form medicines and intermediary products including active pharmaceutical ingredients. The Corporate segment is involved in group management and central services. The company was founded on February 29, 1996 and is headquartered in Basel, Switzerland.

Basel, December 16, 2020 — Novartis today announced that the US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto® (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF). This was based on data supporting the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits) in patients studied in PARAGON-HF. If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction (HFrEF), both based on trials that included active comparators (valsartan and enalapril, respectively)1,2.

Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF

Novartis' (NVS) late-stage study on ruxolitinib in COVID-19 patients did not meet its primary endpoint.

Novartis' (NVS) COVID-19 Study Fails to Meet Primary Endpoint

Basel, December 15, 2020 — Novartis today announced positive findings from the first interpretable results of the Phase III KESTREL study, assessing the efficacy and safety of Beovu® (brolucizumab) 3 mg and 6 mg in diabetic macular edema (DME). Following KITE*, KESTREL is the second pivotal Phase III study of Beovu in DME. The trial met its primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline of Beovu 6 mg to aflibercept 2 mg at year one. The trial also met its key secondary endpoint of non-inferiority in average change in BCVA of Beovu 6 mg to aflibercept 2 mg over week 40 through week 521. (Beovu 6 mg is the marketed dose for wet AMD.)

Novartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edema

Basel, December 14, 2020 — Novartis today announced that the Phase III RUXCOVID study evaluating ruxolitinib on top of standard of care (SoC) therapy compared to SoC treatment alone in patients with COVID-19 did not meet its primary endpoint1. Initial data show there was no statistically significant reduction in the proportion of patients on ruxolitinib plus SoC therapy who experienced severe complications, including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) by Day 29, compared to SoC alone1. The trial also did not show clinically relevant benefit among secondary and exploratory endpoints including mortality rate by Day 29, and time to recovery (no longer infected, or ambulatory with no or minimal limitations)1.

Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19

Basel, December 9 , 20 20 — Novartis today announced new Kisqali® (ribociclib) data demonstrating consistent efficacy benefit with Kisqali plus endocrine therapy across the main intrinsic subtypes of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer. The largest biomarker analysis of efficacy in intrinsic subtypes evaluated whether there was a correlation between these subtypes and efficacy outcomes in patients treated with Kisqali across the three Phase III MONALEESA trials1. The findings will be presented in an oral presentation at the 2020 San Antonio Breast Cancer Virtual Symposium.

Novartis Kisqali® data demonstrate superior benefit across main intrinsic subtypes in metastatic breast cancer

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According to the All-in-One Screener, a Premium feature of GuruFocus, four German and Swiss companies with at least four gurus owning shares are Novartis AG (XSWX:NOVN)(NYSE:NVS), Nestle SA (XSWX:NESN), SAP SE (XTER:SAP)(NYSE:SAP) and Cie Financiere Richemont SA (XSWX:CFR).

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Novartis acquired AveXis in 2018 to jumpstart their transition to cell and gene modalities. The approval of Kymriah in 2017 has led to the expected tepid growth but is a stepping stone to the future.

Novartis: Leading Pharma Into Growth Era

Basel, December 8 , 20 20 — Detailed results from the Phase III ASCEMBL study demonstrate that, at 24 weeks, asciminib (ABL001) – a novel investigational treatment specifically targeting the ABL myristoyl pocket (STAMP) – nearly doubled the major molecular response (MMR) rate compared to Bosulif® (bosutinib)* (25.5% vs. 13.2%, respectively ([95% CI, 2.19-22.3]; 2-sided P=0.029) in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine-kinase inhibitors (TKIs)1. These data were presented today at a late-breaking abstracts session during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH).

Novartis investigational STAMP inhibitor asciminib (ABL001) shows superior MMR rate to Bosulif®* in chronic myeloid leukemia trial

Basel, December 5, 2020 — Novartis announced analyses from two separate trials with Kymriah® (tisagenlecleucel) in patients with certain advanced lymphomas. In the interim analysis of the investigational Phase II ELARA study, Kymriah led to a complete response (CR) in 65% of patients with relapsed or refractory (r/r) follicular lymphoma (FL) and an overall response rate (ORR) of 83% after at least three months of follow-up. These patients continued to relapse or have refractory disease despite exposure to numerous lines of therapy (median four prior lines of therapy [range 2-13]) prior to Kymriah infusion1. The second analysis – a 40-month median follow-up from the Phase II JULIET trial – reported that the two-year progression-free survival (PFS) rate was 33% in patients with r/r diffuse large B-cell lymphoma (DLBCL), an important finding given these patients have limited treatment options that provide durable responses2. The JULIET study continued to show the effectiveness and well-characterized safety profile of Kymriah for these patients. These results were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH).

Novartis analyses confirm benefit of Kymriah® with clinically meaningful rates of complete response seen in patients with certain advanced lymphomas

Basel, December 4 , 20 20 — Detailed results from the pivotal Phase III REACH3 study demonstrate Jakavi® (ruxolitinib) significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD) compared to best available therapy (BAT)1. The results of REACH3, the first successful, randomized Phase III trial in chronic GvHD, were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH). REACH3 is jointly sponsored by Novartis and Incyte.

Novartis announces first data from REACH3 trial showing Jakavi® (ruxolitinib) significantly improved outcomes in patients with steroid-resistant/dependent chronic GvHD

EAST HANOVER, N.J., Dec. 1, 2020 /PRNewswire/ -- Novartis today announced that the US Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult...

Novartis announces FDA approval of Xolair® (omalizumab) for adults with nasal polyps

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Novartis' shares are inexpensive and trade at a discount to its historic valuation range. Shares offer a solid dividend yield of 3.5% at current prices.

Novartis: Leading Pharma Player Offers A Solid Yield And Upside Potential

On Tuesday, Swiss biopharma company Novartis AG (NYSE: NVS) announced a $2.5 billion share buyback program. The management also exhibited a heightened confidence level in its sales projections based on the current pipeline of products under development.

Novartis Kicks Off $2.5B Share Buyback Program On Strong Pipeline Growth

Basel, November 24, 20 20 — Novartis is hosting today its annual Meet Novartis Management event giving investors and industry analysts the opportunity to meet with key executives across the company. The virtual meeting provides a deeper view into the company's progress on its ongoing transformation and growth strategy focused on becoming the leading medicines company powered by data science and advanced therapy platforms.

Novartis highlights confidence in growing sales with margin expansion, fueled by in-market brands and a rich pipeline, at Annual Meet the Management investor event

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Novartis (NVS) enters into a license agreement with Mesoblast for remestemcel-L for the treatment of acute respiratory distress syndrome and other indications.

Novartis (NVS) Partners With Mesoblast for ARDS Cell Therapy

Basel, November 19 , 20 20 — Novartis announced today that it entered into an exclusive worldwide license and collaboration agreement with Mesoblast to develop, commercialize and manufacture remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. ARDS is an area of significant unmet need, with an approximate 40% mortality rate with current standard of care, which includes prolonged ICU treatment and mechanical ventilation.1 ,2 As the potential first ARDS therapy, remestemcel-L will use mesenchymal stromal cells (MSCs), a cell-based platform technology, to treat this deadly condition and improve outcomes. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing 300-patient Phase III study.3 Novartis intends to initiate a Phase III study in non-COVID-19-related ARDS after the anticipated closing of the license agreement and successful completion and outcome of the current study.

Novartis secures exclusive rights for potential acute respiratory distress syndrome cell therapy

The digital press release with multimedia content can be accessed here:

New data at ASH to reinforce breadth of Novartis hematology portfolio across multiple blood cancers and serious hematologic diseases

Basel, November 19 , 20 20 — Novartis today announced the signature of five virtual power purchase agreements (VPPAs), which are expected to collectively add more than 275 megawatts of clean power to the electrical grid. This move makes Novartis the first pharmaceutical company set to achieve 100% renewable electricity in its European operations through VPPAs.

Novartis set to achieve 100% renewable electricity in its European operations

Using traditional metrics, it seems in peril, but investors need to take a closer look in order to judge just how safe the payout is.

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New Novartis analyses for investigational inclisiran demonstrate consistently effective and sustained LDL-C reduction at month 17 regardless of age and gender

Basel, November 6 , 20 20 — Novartis today announced new data from an interim analysis for the randomized, double-blind, placebo-controlled CAN-COVID trial evaluating the efficacy and safety of canakinumab in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS)6. The ongoing trial failed to meet its primary endpoint showing that treatment with canakinumab plus standard of care (SoC) did not demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with placebo plus SoC up to Day 291. The trial did not meet its key secondary endpoint of reducing the COVID-19-related death rate during the 4-week period after treatment1. The safety profiles of canakinumab plus SoC and placebo plus SoC were comparable1.

Novartis provides update on CAN-COVID trial in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS)

Basel, November 5, 2020 — Novartis, a leader in rheumatology and immuno-dermatology, today announced 12-week results from the first-of-its-kind Phase IIIb ULTIMATE randomized controlled trial, which demonstrated the significant treatment response of Cosentyx® (secukinumab) on synovitis (joint lining inflammation) in psoriatic arthritis (PsA) versus placebo. Synovitis was assessed using an advanced and sensitive imaging technique called Power Doppler ultrasonography (PDUS). These data are being presented at the American College of Rheumatology (ACR) All-Virtual Annual Meeting, November 5-9, 2020.

Novartis Cosentyx® shows early synovitis reduction in patients with psoriatic arthritis in first-of-its-kind study

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