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, June 0 6 , 20 2 1 — Novartis today announced Phase II primary endpoint data showing investigational iptacopan (LNP023) – a first-in-class, oral, targeted factor B inhibitor – reduced protein in the urine (proteinuria), an increasingly recognized surrogate marker correlating with progression to kidney failure2, and showed promise in stabilizing kidney function in patients with IgA nephropathy (IgAN)1. The data were presented at the 58th ERA-EDTA Congress held virtually from June 5–8, 2021.

Novartis announces iptacopan met Phase II study primary endpoint in rare kidney disease IgA nephropathy (IgAN)

Novartis AG (NYSE: NVS) reported the final analysis from the NETTER-1 phase 3 study comparing Lutathera plus 30 mg Sandostatin LAR (octreotide) to 60 mg octreotide LAR in patients with midgut neuroendocrine tumors. Lutathera failed to significantly prolong the lives of patients with midgut neuroendocrine tumors, according to data unveiled at the American Society of Clinical Oncology.

Novartis' Neuroendocrine Tumors Targeted Radiotherapy Takes Small Hit on Clinically Relevant Overall Survival

Novartis (NVS) posts results from a late-stage study on radioligand therapy at the 2021 ASCO.

Novartis (NVS) Announces Data on Radioligand Therapy at ASCO

Basel, June 4, 2021 — Novartis today announced the first published mature overall survival (OS) and updated overall response rate (ORR) data following treatment with Tabrecta® (capmatinib) in adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14)1-3. Data from the ongoing, pivotal, multi-cohort Phase II GEOMETRY mono-1 study will be presented today during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting (Poster Discussion Session, Lung Cancer—Non-Small Cell Metastatic; June 4, 2021, 9:00 AM-10:00 AM CT; abstract 9020).

Novartis announces Tabrecta® first published overall survival and updated overall response data in patients with METex14 metastatic NSCLC

Basel, June 4, 2021 — Novartis announced today results from the pivotal Phase III RATIONALE 302 trial showing the investigational anti-PD-1 immune checkpoint inhibitor tislelizumab improved overall survival (OS) versus chemotherapy (median 8.6 months vs. 6.3 months, p=0.0001).1 The study evaluated tislelizumab in patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who had received prior systemic therapy. Results were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Novartis investigational checkpoint inhibitor tislelizumab met primary endpoint of overall survival in pivotal Phase III trial of esophageal cancer after systemic therapy

Novartis AG (NYSE: NVS) has announced results from Phase 3 VISION study evaluating 177Lu-PSMA-617, a targeted radioligand therapy, plus best standard of care (SOC) in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Novartis said it would file for approval for the drug, known as Lu-PSMA-617, in the US and Europe in the second half of 2021 while pushing forward with pivotal studies on earlier-stage patients.

Novartis' Prostate Cancer Radioligand Therapy Extended Overall Survival by Four Months

Basel, June 3, 2021 — Novartis today announced that results of the Phase III VISION study evaluating 177Lu-PSMA-617, a targeted radioligand therapy, plus best standard of care (SOC) demonstrated significant improvement in overall survival (OS) compared to SOC alone, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)1. The difference in OS between study arms was statistically significant (one-sided p

Novartis 177Lu-PSMA-617 significantly improves overall survival and radiographic progression-free survival for men with metastatic castration-resistant prostate cancer in Phase III VISION study

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Basel, June 2, 2021 — Novartis today announced robust data from the primary analysis of the pivotal Phase II ELARA trial of Kymriah® (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL)1. Data will be presented as an oral presentation during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting (Abstract #7508; oral presentation: Monday, June 7, 10:30 AM CDT).

Novartis Kymriah® pivotal trial demonstrates strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma

Novartis AG (NYSE: NVS) said that the Phase 3 JUNIPERA study met its primary endpoint, with Cosentyx (secukinumab) showing a significantly longer time to worsening of symptoms compared to placebo in pediatric patients with two subtypes of juvenile idiopathic arthritis (JIA). The data will be presented at the EULAR 2021 Annual European Congress of Rheumatology.

Novartis's Late-stage Study On Cosentyx Hits Primary Endpoint Goal In Juvenile Idiopathic Arthritis

The FDA has approved Novartis AG's (NYSE: NVS) Cosentyx (secukinumab) to treat moderate to severe plaque psoriasis in pediatric patients six years and older and are candidates for systemic therapy or phototherapy. The approved dosing is 75 mg or 150 mg depending on the child's weight at the time of dosing and is administered by subcutaneous injection every four weeks after an initial loading regimen.

Novartis's Cosentyx Wins FDA Approval For Psoriasis In Pediatric Patients

Basel, June 2, 2021 — Novartis, a leader in rheumatology and immuno-dermatology, today announced 2-year positive results from the Phase III JUNIPERA study, demonstrating that Cosentyx® (secukinumab) significantly delayed time to flare vs placebo (P

Novartis presents positive Phase III results from JUNIPERA study supporting Cosentyx® as a potential treatment in a JIA population at EULAR 2021

Novartis AG (NYSE: NVS) has announced that three Phase 3 studies evaluating Beovu (brolucizumab) in patients with retinal diseases will be terminated early after more frequent dosing intervals were associated with higher rates of intraocular inflammation. The MERLIN study and the RAPTOR and RAVEN studies will be stopped.

Novartis Terminates Three Beovu Studies in Ocular Disorders Citing Patient Safety

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Novartis (NVS) initiates study for investigating its novel DARPin therapeutic candidate, ensovibep (MP0420), for the treatment of COVID-19, in collaboration with Molecular Partners.

Novartis (NVS) & Molecular Partners Initiate Study for COVID-19

Novartis AG (NYSE: NVS) along with Molecular Partners AG (OTC: MLLCF) is kicking off a Phase 2/3 EMPATHY study of DARPin therapeutic candidate, ensovibep (MP0420), to treat COVID-19. The program is investigating the safety and efficacy of ensovibep in patients with COVID-19, who are in the early stages of infection, to prevent worsening symptoms and hospitalization.

Novartis, Molecular Partners Initiate Global Trial For COVID-19 Treatment

EMPATHY global multi-center Phase 2 - 3 study, recruiting patients with COVID-19 infection, aiming to prevent worsening symptoms and hospitalization The study plans to enroll 2100 patients, with 400 patients to be enrolled into Phase 2, followed by 1700 patients in Phase 3 Novartis has been granted an option from Molecular Partners to in-license global rights of ensovibep and MP0423 - DARPin® antiviral therapeutic candidates that are undergoing testing to target SARS-CoV-2 spike protein DARPin® therapeutics well suited for a pandemic setting due to multi-specific target binding, long half-life for sustained activity and highly scalable production, compared to monoclonal antibodies ZURICH-SCHLIEREN, SWITZERLAND / ACCESSWIRE / May 27, 2021 / Molecular Partners AG (SIX:MOLN) and Novartis announced today the start of the clinical trial EMPATHY, a Phase 2 and 3 study, to explore the use of its novel DARPin® therapeutic candidate ensovibep (MP0420) for the treatment of COVID-19. Novartis will conduct the clinical trial program for ensovibep, with Molecular Partners as sponsor of the studies.

Novartis and Molecular Partners announce start of EMPATHY clinical trial for ensovibep for the treatment of COVID-19

Basel, May 19, 2021 — Novartis will present new data from its portfolio of approved and investigational targeted, radioligand, cell and gene and immunotherapies at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2021 European Hematology Association (EHA) Virtual Congress. More than 110 abstracts, including Novartis-sponsored and investigator-initiated trials, will be presented at the meetings.

Novartis to unveil new data at ASCO and EHA from its robust portfolio, including overall survival in prostate and breast cancer

Novartis AG (NVS) Presents at Cardiovascular Update Broker Conference Call - (Transcript)

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The Supreme Court turned away a petition from Sandoz seeking to challenge two Amgen Inc (NASDAQ: AMGN) patents related to rheumatoid arthritis drug Enbrel, thus blocking Novartis AG's (NYSE: NVS) Sandoz from selling a biosimilar of the drug in the U.S. until 2029. The justices turned away Novartis subsidiary Sandoz Inc's appeal of a lower court decision that upheld the validity of the patents.

Supreme Court Rebuffs Novartis Appeal Over Amgen's Arthritis Drug Enbrel: Report

Novartis AG (NYSE: NVS) revealed details on Phase 3 PARADISE-MI trial evaluating Entresto (sacubitril/valsartan) compared with ramipril in a contemporary acute myocardial infarction (AMI) population. Data were presented at the American College of Cardiology's virtual Scientific Session.

Novartis' Entresto Misses Primary Endpoint In Study After Heart Attacks

The stock price of Novartis AG (NYSE: NVS) increased by 1.01% as it went from $85.24 to $86.10 pre-market. This is why it happened.

NVS Stock: From $85.24 To $86.10 (1.01% Increase) Pre-Market Explanation

Novartis AG (NYSE: NVS) has reported that its Beovu (brolucizumab) drug met primary endpoints in Phase 3 KESTREL and KITE trials conducted in diabetic macular edema (DME) patients. According to one-year data, 6mg Beovu showed non-inferiority in change in best-corrected visual acuity from baseline compared to 2mg Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) Eylea (aflibercept).

Novartis' Beovu Non-Inferior To Aflibercept In Phase 3 Diabetic Macular Edema Study

Basel, May 1, 2021 — Novartis today announced positive one-year results of the Phase III KESTREL and KITE* studies, evaluating the efficacy and safety of Beovu® (brolucizumab) 6 mg in diabetic macular edema (DME). Both studies met their primary endpoints of non-inferiority in change in best corrected visual acuity (BCVA) from baseline for Beovu 6 mg versus aflibercept 2 mg at year one1. In KESTREL, patients on Beovu 6 mg gained a mean of 9.2 letters versus 10.5 letters for patients on aflibercept 2 mg1. In KITE, patients on Beovu 6 mg gained a mean of 10.6 letters versus 9.4 letters for patients on aflibercept 2 mg1. These results will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting.

Novartis Phase III Beovu® data show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept

The Eaton Vance Worldwide Health Sciences Fund (Trades, Portfolio) sold shares of the following stocks during the first quarter of 2021, which ended on March 31.

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