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Novartis' Fabhalta Shows Promise in Addressing Critical Gaps in C3 Glomerulopathy Treatment
GlobeNewswire News Room· 2024-06-13 15:39
C3G Disease Overview - C3G is a rare kidney disease with no specifically approved therapies, leading most patients to progress to kidney failure requiring dialysis or transplant [8] - Current treatments are complex and burdensome, often involving combinations of antihypertensive agents, SGLT2 inhibitors, corticosteroids, and immunosuppressive agents [9] - Nephrologists adjust treatment approaches based on eGFR decline and proteinuria levels, with SGLT2 inhibitor use increasing year-over-year [9] Physician Perspectives and Challenges - 148 nephrologists across EU5 countries emphasize the urgent need for effective C3G treatments and the importance of early intervention [1] - Less than half of EU5 nephrologists feel confident in achieving target proteinuria levels with current treatments [2] - Over 75% of audited C3G patients are expected to progress to end-stage renal disease within the next decade [2] Emerging Treatment Landscape - Promising new treatments in development include Novartis' Fabhalta (iptacopan) and Apellis' Empaveli (pegcetacoplan) [3] - Phase III APPEAR-C3G study showed Fabhalta plus supportive care achieved a 35.1% reduction in proteinuria at 6 months compared to placebo [10] - Additional pipeline assets from Q32 Bio, Omeros, and others offer hope for better C3G management [3] Market Research and Insights - Spherix's Patient Chart Dynamix™ service analyzes real patient management patterns and treatment decision drivers [4] - Market Dynamix™ provides analysis of markets expected to experience paradigm shifts in 3-5 years, including C3G [12] - Spherix monitors specialty markets across multiple therapeutic areas through its extensive Physician Community [13]
Why Novartis (NVS) is a Top Value Stock for the Long-Term
ZACKS· 2024-06-06 14:46
That's where the Style Scores come in. To maximize your returns, you want to buy stocks with the highest probability of success. This means picking stocks with a Zacks Rank #1 or #2 that also have Style Scores of A or B. If you find yourself looking at stocks with a #3 (Hold) rank, make sure they have Scores of A or B as well to ensure as much upside potential as possible. The direction of a stock's earnings estimate revisions should always be a key factor when choosing which stocks to buy, since the Scores ...
Why Novartis (NVS) is a Top Momentum Stock for the Long-Term
ZACKS· 2024-06-04 14:56
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Novartis AG (NVS) Investor Event at ASCO Conference Call (Transcript)
Seeking Alpha· 2024-06-03 21:24
Novartis AG (NYSE:NVS) Investor Event at ASCO Conference Call June 2, 2024 7:00 PM ET Company Participants Parag Mahanti - Investor Relations Shreeram Aradhye - President of Global Drug Development and Chief Medical Officer Jeff Legos - Global Head of Oncology & Hematology Drug Development Reshema Kemps-Polanco - Chief Commercial Officer of U.S. Business Rodney Gillespie - International Therapeutic Area Head, Oncology Novartis Conference Call Participants Emmanuel Papadakis - Deutsche Bank Steve Scala - TD ...
Novartis Phase III data confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria
GlobeNewswire News Room· 2024-05-30 22:01
Patients treated with remibrutinib experienced improvements in weekly urticaria activity scores (UAS7) observed as early as Week 1 and sustained to 1 year (Week 52)1 Remibrutinib, an oral Bruton's tyrosine kinase inhibitor, demonstrated a favorable and consistent safety profile up to 1 year, including balanced liver function tests versus placebo1 Novartis intends to submit remibrutinib for approval in chronic spontaneous urticaria (CSU) to global health authorities starting in H2 2024, and continues to inve ...
Novartis (NVS) Presents Positive Data on Renal Drugs at ERA
zacks.com· 2024-05-27 17:31
Novartis (NVS) announced results from the six-month, double-blind trial period of the late-stage APPEAR- C3G study of Fabhalta. Fabhalta, an oral Factor B inhibitor of the alternative complement pathway, is being investigated in adult patients with C3 glomerulopathy (C3G). APPEAR-C3G is a phase III multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of twice-daily oral Fabhalta (200 mg) in C3G patients. The study comprises a six-month double-bl ...
Novartis: Buy This Blue-Chip Dividend Stock On Sale Now
seekingalpha.com· 2024-05-27 11:00
Core Viewpoint - Novartis is currently performing well despite a recent decline in net sales due to the spin-off of its Sandoz business, with strong growth in continuing operations and a positive outlook for future earnings and dividends [3][11][35] Financial Performance - Q1 2023 net sales were $12.953 billion, a 3% increase year-over-year, while Q1 2024 net sales decreased to $11.829 billion, an 8.7% decline due to the Sandoz spin-off [6][9] - Adjusted for the spin-off, net sales from continuing operations grew by 9.5% year-over-year in Q1 2024, with currency-neutral net sales increasing by 11% [11] - Core EPS for Q1 2024 rose by 16.9% to $1.80, exceeding analyst expectations [14] Growth Drivers - Novartis' top 20 brands saw net sales increase by 16% to $9.3 billion in Q1 2024, with 13 out of 20 brands experiencing growth [12][13] - The company has over 100 projects in clinical development and plans to submit more than two dozen indications in core therapeutic areas to regulatory authorities [16][17] Debt and Financial Health - Net debt increased from $10.2 billion to $15.8 billion, primarily due to a $5.2 billion annual dividend payment, but remains manageable [19] - Novartis maintains an AA- credit rating from S&P, indicating strong financial health and stability [20] Valuation and Dividend - Current P/E ratio is 13.8, below the 10-year average of 16.3, suggesting the stock is undervalued [22] - The forward dividend yield is 3.7%, significantly higher than the healthcare sector median of 1.5%, with a consistent annual growth of 6.9% over the last five years [28][30]
Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolio
globenewswire.com· 2024-05-25 10:15
Basel, May 25, 2024 – Novartis today presented results from a pre-specified interim analysis of the Phase III ALIGN study of atrasentan, an investigational oral selective endothelin A (ETA) receptor antagonist, in patients with IgA nephropathy (IgAN)1. Patients treated with atrasentan, in addition to supportive care (maximally tolerated and stable dose of a renin-angiotensin system [RAS] inhibitor), achieved a 36.1% (p<0.0001) reduction in proteinuria (as measured by 24-hour urine protein to creatinine rati ...
Novartis presents latest Phase III Fabhalta® (iptacopan) data in C3 glomerulopathy (C3G) showing clinically meaningful and statistically significant 35.1% proteinuria reduction vs. placebo
prnewswire.com· 2024-05-25 10:00
EAST HANOVER, N.J., May 25, 2024 /PRNewswire/ -- Novartis today presented results from the 6-month, double-blind period of the Phase III APPEAR-C3G study of Fabhalta® (iptacopan) at the late-breaking clinical trials session of the European Renal Association (ERA) Congress1. Patients treated with Fabhalta in addition to supportive care achieved a 35.1% (p=0.0014) reduction in proteinuria (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at 6 months when compared to placebo on top of supportiv ...
Motor Neuron Disease Clinical Trial Pipeline Appears Robust With 120+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight
Newsfilter· 2024-05-16 17:00
New York, USA, May 16, 2024 (GLOBE NEWSWIRE) -- Motor Neuron Disease Clinical Trial Pipeline Appears Robust With 120+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight Diagnosing motor neuron diseases often presents challenges as there are no definitive tests in many cases. Motor neuron disease symptoms can vary widely among individuals and, in the early stages, may resemble those of other illnesses, complicating diagnosis. However, specific gene tests are available for condit ...