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Novartis (NVS) Announces Positive Data on Kidney Disease Drug
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Novartis AG (NVS - Free Report) announced positive top-line results from the pre-specified interim analysis of the late-stage study on pipeline candidate iptacopan in patients with IgA nephropathy (IgAN).
Iptacopan is an oral, proximal complement inhibitor that binds factor B and inhibits the alternative complement pathway.
APPLAUSE-IgAN is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of twice-daily oral iptacopan (200 mg) in 470 adults with primary IgAN.
IgAN is a complement-mediated kidney disease that mostly affects young adults. It is a major cause of chronic kidney disease and kidney failure worldwide.
Iptacopan demonstrated superiority versus placebo in proteinuria (protein in urine) reduction and provided a clinically meaningful and highly statistically significant proteinuria reduction on top of supportive care in patients with IgAN.
The safety profile of the candidate was consistent with previously reported data.
The APPLAUSE study continues to evaluate iptacopan’s ability to slow IgAN progression by measuring the estimated glomerular filtration rate slope over 24 months – the primary endpoint at the study end, with topline results expected in 2025.
Meanwhile, iptacopan is currently under review for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
The candidate is also being evaluated in phase III studies for C3 glomerulopathy (C3G), immune complex membranoproliferative glomerulonephritis and atypical hemolytic uremic syndrome.
It has been granted Breakthrough Therapy Designation in PNH and C3G by the FDA. Iptacopan also enjoys orphan drug designations from the FDA and European Medicines Agency in PNH and C3G.
Novartis recently acquired Chinook Therapeutics for $3.5 billion to strengthen its renal pipeline. The acquisition added two late-stage candidates, atrasentan and zigakibart (BION-1301), IgAN, to Novartis’ pipeline.
Shares of Novartis have risen 9.8% year to date compared with the industry’s 4.2% growth.
Image Source: Zacks Investment Research
Novartis is currently streamlining its pharmaceutical portfolio. The company recently completed the divestment of its “front of eye” ophthalmology assets to Bausch + Lomb (BLCO - Free Report) , a global eye-health company, for $2.5 billion.
The deal includes Xiidra, a treatment for the signs and symptoms of dry eye disease, and investigational medicine SAF312 (libvatrep), in development as a first-in-class therapy for chronic ocular surface pain, as well as the AcuStream delivery device in dry eye indications and OJL332 in pre-clinical development.
In view of the same, BLCO recently launched an offering of $1.4 billion in aggregate principal amount of new senior secured notes due 2028 to finance the acquisition of Xiidra.
BLCO was also looking to enter into an incremental term loan facility in the form of an incremental amendment to its existing term loan facility or a separate credit agreement.
Novartis is looking to become a pure-play pharmaceutical company. While the older drugs face generic competition, the continued strong performance of Entresto, Pluvicto, Kesimpta and Kisqali fuels growth and should maintain momentum.
The strong performance of key drugs, strategic acquisitions and a streamlined focus should pave the way for NVS’ solid growth in the quarters ahead.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 24 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 2 cents per share.
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Novartis (NVS) Announces Positive Data on Kidney Disease Drug
Novartis AG (NVS - Free Report) announced positive top-line results from the pre-specified interim analysis of the late-stage study on pipeline candidate iptacopan in patients with IgA nephropathy (IgAN).
Iptacopan is an oral, proximal complement inhibitor that binds factor B and inhibits the alternative complement pathway.
APPLAUSE-IgAN is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of twice-daily oral iptacopan (200 mg) in 470 adults with primary IgAN.
IgAN is a complement-mediated kidney disease that mostly affects young adults. It is a major cause of chronic kidney disease and kidney failure worldwide.
Iptacopan demonstrated superiority versus placebo in proteinuria (protein in urine) reduction and provided a clinically meaningful and highly statistically significant proteinuria reduction on top of supportive care in patients with IgAN.
Novartis AG Price, Consensus and EPS Surprise
Novartis AG price-consensus-eps-surprise-chart | Novartis AG Quote
The safety profile of the candidate was consistent with previously reported data.
The APPLAUSE study continues to evaluate iptacopan’s ability to slow IgAN progression by measuring the estimated glomerular filtration rate slope over 24 months – the primary endpoint at the study end, with topline results expected in 2025.
Meanwhile, iptacopan is currently under review for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
The candidate is also being evaluated in phase III studies for C3 glomerulopathy (C3G), immune complex membranoproliferative glomerulonephritis and atypical hemolytic uremic syndrome.
It has been granted Breakthrough Therapy Designation in PNH and C3G by the FDA. Iptacopan also enjoys orphan drug designations from the FDA and European Medicines Agency in PNH and C3G.
Novartis recently acquired Chinook Therapeutics for $3.5 billion to strengthen its renal pipeline. The acquisition added two late-stage candidates, atrasentan and zigakibart (BION-1301), IgAN, to Novartis’ pipeline.
Shares of Novartis have risen 9.8% year to date compared with the industry’s 4.2% growth.
Image Source: Zacks Investment Research
Novartis is currently streamlining its pharmaceutical portfolio. The company recently completed the divestment of its “front of eye” ophthalmology assets to Bausch + Lomb (BLCO - Free Report) , a global eye-health company, for $2.5 billion.
The deal includes Xiidra, a treatment for the signs and symptoms of dry eye disease, and investigational medicine SAF312 (libvatrep), in development as a first-in-class therapy for chronic ocular surface pain, as well as the AcuStream delivery device in dry eye indications and OJL332 in pre-clinical development.
In view of the same, BLCO recently launched an offering of $1.4 billion in aggregate principal amount of new senior secured notes due 2028 to finance the acquisition of Xiidra.
BLCO was also looking to enter into an incremental term loan facility in the form of an incremental amendment to its existing term loan facility or a separate credit agreement.
Novartis is looking to become a pure-play pharmaceutical company. While the older drugs face generic competition, the continued strong performance of Entresto, Pluvicto, Kesimpta and Kisqali fuels growth and should maintain momentum.
The strong performance of key drugs, strategic acquisitions and a streamlined focus should pave the way for NVS’ solid growth in the quarters ahead.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the industry are Eton Pharmaceuticals (ETON - Free Report) and Dynavax Technologies (DVAX - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 24 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 2 cents per share.