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Roche's Gazyva Secures FDA Nod for Label Expansion in Lupus Nephritis
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Key Takeaways
FDA approves Roche's Gazyva for adults with active lupus nephritis receiving standard therapy.
Approval based on strong phase II and III data showing significant renal response improvements.
Patients can now receive shorter infusions and fewer annual doses, enhancing treatment convenience.
Roche (RHHBY - Free Report) announced that the FDA has approved a regulatory filing seeking the label expansion of Gazyva/Gazyvaro (obinutuzumab) to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy.
The approval also allows eligible patients to receive subsequent infusions in a shortened 90-minute timeframe after the initial dose. Following four doses in the first year, Gazyva/Gazyvaro can be administered twice yearly, providing an effective and potentially more convenient alternative to traditional targeted therapies for preventing long-term complications, including kidney failure.
Please note that Roche’s Gazyva/Gazyvaro has already been approved in 100 countries for various types of hematological cancers. In the United States, Roche markets the drug in partnership with Biogen.
FDA Clears RHHBY’s Gazyva for Lupus After Phase III Success
The FDA’s decision is supported by positive data from Roche’s phase II NOBILITY and phase III REGENCY studies.
The REGENCY study met its primary endpoint with statistical significance and demonstrated clinically meaningful treatment benefits in active LN patients. Per the data readout, nearly half of the patients treated with the combo regimen of Gazyva/Gazyvaro and standard therapy achieved a complete renal response at 76 weeks compared with those treated with standard therapy alone.
Per Roche, such robust results underscore the drug’s unique mechanism of action for potential long-term preservation of kidney function and delay/prevention of end-stage kidney disease.
Year to date, RHHBY shares have gained 26.3% compared with the industry’s 5.1% growth.
Image Source: Zacks Investment Research
The phase III REGENCY study data also demonstrated significant improvements in complement levels, reductions in anti-dsDNA, lower corticosteroid use and decreased proteinuria, all indicating better disease control. The drug was overall well tolerated, demonstrating a safety profile consistent with that observed in prior clinical studies. Additionally, no new safety signals were identified.
LN is a serious condition caused by an autoimmune disease that affects about 1.7 million people globally, mostly women of color in their childbearing years. In this disease, harmful B cells cause persistent inflammation that damages the kidneys. Without treatment, up to one-third of patients may advance to end-stage kidney disease, frequently necessitating dialysis or a kidney transplant, which comes with a high risk of death.
Importantly, Roche’s Gazyva/Gazyvaro enjoys the FDA’s Breakthrough Therapy designation in the United States for the treatment of LN.
A similar regulatory filing is also currently under review in the EU. The advisory committee to the European Medicines Agency recently adopted a positive opinion supporting the approval of Gazyva/Gazyvaro for adults with active LN, with a final decision from the European Commission anticipated soon.
Roche is also currently evaluating Gazyva/Gazyvaro in separate clinical studies to treat children and adolescents with LN, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus.
In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 55.1% year to date.
Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.
In the past 60 days, estimates for Alnylam’s 2025 earnings per share have risen from $3.34 to $3.81. During the same period, earnings per share for 2026 have increased from $9.23 to $9.97. Year to date, ALNY’s shares have surged 99.9%.
Alnylam’s earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 348.36%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have risen from $7.25 to $7.29. During the same period, earnings per share for 2026 have increased from $7.74 to $7.81. Year to date, ANIP’s shares have rallied 66.5%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with an average surprise of 22.66%.
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Roche's Gazyva Secures FDA Nod for Label Expansion in Lupus Nephritis
Key Takeaways
Roche (RHHBY - Free Report) announced that the FDA has approved a regulatory filing seeking the label expansion of Gazyva/Gazyvaro (obinutuzumab) to treat adult patients with active lupus nephritis (LN) who are receiving standard therapy.
The approval also allows eligible patients to receive subsequent infusions in a shortened 90-minute timeframe after the initial dose. Following four doses in the first year, Gazyva/Gazyvaro can be administered twice yearly, providing an effective and potentially more convenient alternative to traditional targeted therapies for preventing long-term complications, including kidney failure.
Please note that Roche’s Gazyva/Gazyvaro has already been approved in 100 countries for various types of hematological cancers. In the United States, Roche markets the drug in partnership with Biogen.
FDA Clears RHHBY’s Gazyva for Lupus After Phase III Success
The FDA’s decision is supported by positive data from Roche’s phase II NOBILITY and phase III REGENCY studies.
The REGENCY study met its primary endpoint with statistical significance and demonstrated clinically meaningful treatment benefits in active LN patients. Per the data readout, nearly half of the patients treated with the combo regimen of Gazyva/Gazyvaro and standard therapy achieved a complete renal response at 76 weeks compared with those treated with standard therapy alone.
Per Roche, such robust results underscore the drug’s unique mechanism of action for potential long-term preservation of kidney function and delay/prevention of end-stage kidney disease.
Year to date, RHHBY shares have gained 26.3% compared with the industry’s 5.1% growth.
Image Source: Zacks Investment Research
The phase III REGENCY study data also demonstrated significant improvements in complement levels, reductions in anti-dsDNA, lower corticosteroid use and decreased proteinuria, all indicating better disease control. The drug was overall well tolerated, demonstrating a safety profile consistent with that observed in prior clinical studies. Additionally, no new safety signals were identified.
LN is a serious condition caused by an autoimmune disease that affects about 1.7 million people globally, mostly women of color in their childbearing years. In this disease, harmful B cells cause persistent inflammation that damages the kidneys. Without treatment, up to one-third of patients may advance to end-stage kidney disease, frequently necessitating dialysis or a kidney transplant, which comes with a high risk of death.
Importantly, Roche’s Gazyva/Gazyvaro enjoys the FDA’s Breakthrough Therapy designation in the United States for the treatment of LN.
A similar regulatory filing is also currently under review in the EU. The advisory committee to the European Medicines Agency recently adopted a positive opinion supporting the approval of Gazyva/Gazyvaro for adults with active LN, with a final decision from the European Commission anticipated soon.
Roche is also currently evaluating Gazyva/Gazyvaro in separate clinical studies to treat children and adolescents with LN, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus.
Roche Holding AG Price and Consensus
Roche Holding AG price-consensus-chart | Roche Holding AG Quote
RHHBY's Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector are Chemomab Therapeutics (CMMB - Free Report) , Alnylam Pharmaceuticals (ALNY - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While CMMB currently sports a Zacks Rank #1 (Strong Buy), ALNY and ANIP carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Chemomab Therapeutics’ 2025 loss per share have narrowed from $2.40 to 60 cents. Loss per share estimates for 2026 have narrowed from $2.80 to $1.00 during the same period. CMMB stock has plunged 55.1% year to date.
Chemomab Therapeutics’ earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 26.25%.
In the past 60 days, estimates for Alnylam’s 2025 earnings per share have risen from $3.34 to $3.81. During the same period, earnings per share for 2026 have increased from $9.23 to $9.97. Year to date, ALNY’s shares have surged 99.9%.
Alnylam’s earnings beat estimates in three of the trailing four quarters, while meeting the same on the remaining occasion, with an average surprise of 348.36%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have risen from $7.25 to $7.29. During the same period, earnings per share for 2026 have increased from $7.74 to $7.81. Year to date, ANIP’s shares have rallied 66.5%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with an average surprise of 22.66%.