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.

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Novartis has underperformed other healthcare stocks so far. Value remains within normal P/E range.

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Novartis (NVS) gets CRL from the FDA for its cholesterol drug, inclisiran, due to unresolved facility inspection-related conditions.

Novartis (NVS) Gets CRL From the FDA for Cholesterol Drug

The FDA's inability to inspect an overseas manufacturing facility is holding up an application for inclisiran.

FDA Refuses to Approve Novartis' $9.7 Billion Cholesterol Drug for Now

Basel, December 18, 2020 — The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of December 23, 2020, due to unresolved facility inspection-related conditions. The conditions will be conveyed to the European manufacturing facility within 10 business days. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the Novartis NDA may be approved. No onsite inspection was conducted. If it is determined that a facility inspection is needed to approve the application, the FDA will define an approach for scheduling once safe travel may resume based on public health need and other factors.

Novartis receives complete response letter from U.S. FDA for inclisiran

Novartis (NVS) to buy neuroscience company, Cadent, for up to $770 million.

Novartis (NVS) to Acquire Neuroscience Company for Up to $770M

Novartis said on Thursday it had entered into an agreement to acquire U.S.-based neuroscience company Cadent for up to $770 million, gaining full rights to Cadent's neuroscience portfolio.

Novartis to buy neuroscience company Cadent for up to $770 million

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cadent Therapeutics, a privately held clinical stage biopharmaceutical company focused on the development of therapies for the treatment of cognitive, mood, and movement disorders, announced today that it has reached a definitive agreement with Novartis, under which Novartis will acquire all of the outstanding capital stock of Cadent Therapeutics. Upon the closing of the agreement, Cadent will receive a $210 million upfront payment and will be eligible for up

Cadent Therapeutics Enters Agreement to be Acquired by Novartis

Novartis (NVS) gets positive review from the FDA Advisory Committee to support the use of Entresto in the treatment of patients with heart failure with preserved ejection fraction.

Novartis' (NVS) Entresto Gets FDA Panel Nod for Expanded Use

Novartis' bid to pump up sales of its Entresto heart failure medicine beyond $5 billion annually got a boost when a U.S. Food and Drug advisory panel recommended it be used to treat a different form of the disease.

Novartis' bid to boost Entresto sales beyond $5 billion gets FDA panel lift

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.

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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.

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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.

News for Novartis Stock (NVS)