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Roche's Lupus Study for Gazyva Meets Primary & Key Secondary Goals
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Roche (RHHBY - Free Report) announced positive top-line data from a late-stage study of its marketed drug, Gazyva/Gazyvaro (obinutuzumab), to treat patients with active lupus nephritis (LN). The phase III REGENCY study evaluated the efficacy and safety of the drug (biannual intravenous doses) compared with placebo, both combined with standard therapy (mycophenolate mofetil and glucocorticoids) in 271 LN patients.
Please note that Roche’s Gazyva/Gazyvaro has already been approved in 100 countries for various types of lymphoma. In the United States, Roche markets the drug in partnership with Biogen.
Superior Efficacy Data From RHHBY’s Lupus Nephritis Study
The REGENCY study met its primary endpoint with statistical significance and demonstrated clinically meaningful treatment benefits in active LN patients. Per the data readout, a higher proportion of people treated with the combo regimen of Gazyva/Gazyvaro and standard therapy achieved a complete renal response (CRR) at 76 weeks compared with those treated with standard therapy alone.
Roche stated that 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.
The phase III REGENCY study also achieved two key secondary endpoints demonstrating statistically significant and clinically meaningful improvements in LN patients. After 76 weeks of treatment with Gazyva/Gazyvaro plus standard therapy, a higher proportion of patients achieved CRR with reduced corticosteroid use, alongside improved proteinuric response, both critical for enhanced disease control in LN.
Year to date, shares of Roche have gained 10% compared with the industry’s 22.8% growth.
Image Source: Zacks Investment Research
While other secondary endpoints did not reach statistical significance, Gazyva/Gazyvaro showed numerically greater responses across several measures. 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.
RHHBY’s Plans Forward for Gazyva/Gazyvaro to Treat Lupus
Roche is currently gearing up to discuss the late-stage REGENCY study data with regulatory authorities in the United States and EU. 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. Despite current treatments, up to one-third of patients may develop end-stage kidney disease within 10 years, requiring dialysis or a transplant, which comes with a high risk of death. At present, there is no cure for LN.
Based on the encouraging data from the late-stage study of Gazyva/Gazyvaro, the drug has the potential to become a new treatment option for LN, where there is a huge unmet medical need.
Importantly, Gazyva/Gazyvaro currently enjoys the FDA’s Breakthrough Therapy designation in the United States for the treatment of LN.
Roche further stated that it is also currently evaluating Gazyva/Gazyvaro in separate late-stage studies to treat children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE).
Apart from Gazyva/Gazyvaro, Roche’s pipeline also includes several innovative therapies, like RG6299 (high-risk primary immunoglobulin A nephropathy), Lunsumio (SLE), PiaSky (atypical hemolytic uremic syndrome) and RG6382 (SLE).
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 3.9%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have jumped 44.7%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 48.6%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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Roche's Lupus Study for Gazyva Meets Primary & Key Secondary Goals
Roche (RHHBY - Free Report) announced positive top-line data from a late-stage study of its marketed drug, Gazyva/Gazyvaro (obinutuzumab), to treat patients with active lupus nephritis (LN). The phase III REGENCY study evaluated the efficacy and safety of the drug (biannual intravenous doses) compared with placebo, both combined with standard therapy (mycophenolate mofetil and glucocorticoids) in 271 LN patients.
Please note that Roche’s Gazyva/Gazyvaro has already been approved in 100 countries for various types of lymphoma. In the United States, Roche markets the drug in partnership with Biogen.
Superior Efficacy Data From RHHBY’s Lupus Nephritis Study
The REGENCY study met its primary endpoint with statistical significance and demonstrated clinically meaningful treatment benefits in active LN patients. Per the data readout, a higher proportion of people treated with the combo regimen of Gazyva/Gazyvaro and standard therapy achieved a complete renal response (CRR) at 76 weeks compared with those treated with standard therapy alone.
Roche stated that 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.
The phase III REGENCY study also achieved two key secondary endpoints demonstrating statistically significant and clinically meaningful improvements in LN patients. After 76 weeks of treatment with Gazyva/Gazyvaro plus standard therapy, a higher proportion of patients achieved CRR with reduced corticosteroid use, alongside improved proteinuric response, both critical for enhanced disease control in LN.
Year to date, shares of Roche have gained 10% compared with the industry’s 22.8% growth.
Image Source: Zacks Investment Research
While other secondary endpoints did not reach statistical significance, Gazyva/Gazyvaro showed numerically greater responses across several measures. 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.
RHHBY’s Plans Forward for Gazyva/Gazyvaro to Treat Lupus
Roche is currently gearing up to discuss the late-stage REGENCY study data with regulatory authorities in the United States and EU. 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. Despite current treatments, up to one-third of patients may develop end-stage kidney disease within 10 years, requiring dialysis or a transplant, which comes with a high risk of death. At present, there is no cure for LN.
Based on the encouraging data from the late-stage study of Gazyva/Gazyvaro, the drug has the potential to become a new treatment option for LN, where there is a huge unmet medical need.
Importantly, Gazyva/Gazyvaro currently enjoys the FDA’s Breakthrough Therapy designation in the United States for the treatment of LN.
Roche further stated that it is also currently evaluating Gazyva/Gazyvaro in separate late-stage studies to treat children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE).
Apart from Gazyva/Gazyvaro, Roche’s pipeline also includes several innovative therapies, like RG6299 (high-risk primary immunoglobulin A nephropathy), Lunsumio (SLE), PiaSky (atypical hemolytic uremic syndrome) and RG6382 (SLE).
Roche Holding AG Price and Consensus
Roche Holding AG price-consensus-chart | Roche Holding AG Quote
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 3.9%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have jumped 44.7%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 48.6%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.