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Novartis (NVS) Presents Positive Data on Renal Drugs at ERA
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Novartis (NVS - Free Report) 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-blind period, where adult patients are randomized equally to receive Fabhalta or placebo on top of supportive care, followed by a six-month open-label period where all patients receive Fabhalta.
Secondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over six months versus placebo. Results showed that patients treated with Fabhalta, in addition to supportive care, achieved a 35.1% reduction in proteinuria (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at six months when compared to placebo on top of supportive care.
The study also showed that Fabhalta has a favorable safety profile with no new safety signal.
The results were presented at the late-breaking clinical trials session of the European Renal Association (ERA) Congress.
Enrollment is ongoing in a separate cohort of adolescent patients with C3G.
We note that Fabhalta was approved by the FDA in December 2023 and the EMA in May 2024 for the treatment of adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria.
The drug is also being evaluated for a range of rare diseases, including IgA nephropathy (IgAN), C3G, aHUS (atypical hemolytic uremic syndrome), IC-MPGN and lupus nephritis.
A potential approval of Fabhalta for C3G should increase the sales potential of the drug.
Novartis also presented results from a pre-specified interim analysis of the late-stage ALIGN study of atrasentan, an investigational oral selective endothelin A (ETA) receptor antagonist, in patients with IgA nephropathy (IgAN) at the ERA.
Atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine) reduction compared to placebo plus supportive care at 36 weeks.
Novartis remains on track for a regulatory submission of atrasentan to the FDA in the first half of 2024.
Shares of Novartis have lost 0.4% in the year-to-date period against the industry’s growth of 16%.
Image Source: Zacks Investment Research
The acquisition of Chinook Therapeutics in 2023 added two late-stage candidates, atrasentan and zigakibart, for the treatment of IgAN to NVS’ pipeline.
Last month, Novartis posted better-than-expected first-quarter results, wherein both earnings and revenues beat their respective estimates. This is indicative of strong performance across all its key brands in the upcoming quarters.
Novartis is now a pure-play innovative medicine company, with focus on core therapeutic areas — cardiovascular, renal and metabolic, immunology, neuroscience and oncology — post the Sandoz spin off in 2023.
Earlier in the month, Novartis fulfilled tender offer conditions to acquire MorphoSys (MOR - Free Report) for €68 per share in cash. Novartis secured 79.6% acceptance by MorphoSys shareholders during the initial acceptance period, reaching the minimum 65% acceptance threshold.
The acquisition is expected to add MorphoSys’s pelabresib (late-stage BET inhibitor for myelofibrosis) and tulmimetostat (early-stage dual EZH2 and EZH1 inhibitor for solid tumors or lymphomas) to NVS’ pipeline.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for KRYS’ earnings per share has increased 17 cents to $2.06. KRYS beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 21.46%. Shares of Krystal Biotech have surged 31.3% year to date.
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Novartis (NVS) Presents Positive Data on Renal Drugs at ERA
Novartis (NVS - Free Report) 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-blind period, where adult patients are randomized equally to receive Fabhalta or placebo on top of supportive care, followed by a six-month open-label period where all patients receive Fabhalta.
Secondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over six months versus placebo. Results showed that patients treated with Fabhalta, in addition to supportive care, achieved a 35.1% reduction in proteinuria (as measured by 24-hour urine protein to creatinine ratio [UPCR]) at six months when compared to placebo on top of supportive care.
The study also showed that Fabhalta has a favorable safety profile with no new safety signal.
The results were presented at the late-breaking clinical trials session of the European Renal Association (ERA) Congress.
Enrollment is ongoing in a separate cohort of adolescent patients with C3G.
We note that Fabhalta was approved by the FDA in December 2023 and the EMA in May 2024 for the treatment of adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria.
The drug is also being evaluated for a range of rare diseases, including IgA nephropathy (IgAN), C3G, aHUS (atypical hemolytic uremic syndrome), IC-MPGN and lupus nephritis.
A potential approval of Fabhalta for C3G should increase the sales potential of the drug.
Novartis also presented results from a pre-specified interim analysis of the late-stage ALIGN study of atrasentan, an investigational oral selective endothelin A (ETA) receptor antagonist, in patients with IgA nephropathy (IgAN) at the ERA.
Atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine) reduction compared to placebo plus supportive care at 36 weeks.
Novartis remains on track for a regulatory submission of atrasentan to the FDA in the first half of 2024.
Shares of Novartis have lost 0.4% in the year-to-date period against the industry’s growth of 16%.
Image Source: Zacks Investment Research
The acquisition of Chinook Therapeutics in 2023 added two late-stage candidates, atrasentan and zigakibart, for the treatment of IgAN to NVS’ pipeline.
Last month, Novartis posted better-than-expected first-quarter results, wherein both earnings and revenues beat their respective estimates. This is indicative of strong performance across all its key brands in the upcoming quarters.
Novartis is now a pure-play innovative medicine company, with focus on core therapeutic areas — cardiovascular, renal and metabolic, immunology, neuroscience and oncology — post the Sandoz spin off in 2023.
Earlier in the month, Novartis fulfilled tender offer conditions to acquire MorphoSys (MOR - Free Report) for €68 per share in cash. Novartis secured 79.6% acceptance by MorphoSys shareholders during the initial acceptance period, reaching the minimum 65% acceptance threshold.
The acquisition is expected to add MorphoSys’s pelabresib (late-stage BET inhibitor for myelofibrosis) and tulmimetostat (early-stage dual EZH2 and EZH1 inhibitor for solid tumors or lymphomas) to NVS’ pipeline.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the healthcare sector are ALX Oncology Holdings (ALXO - Free Report) and Krystal Biotech (KRYS - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for KRYS’ earnings per share has increased 17 cents to $2.06. KRYS beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 21.46%. Shares of Krystal Biotech have surged 31.3% year to date.