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FDA Accepts RHHBY's sNDA for Gazyva in Treating Lupus Nephritis
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Roche (RHHBY - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its blockbuster drug Gazvya (obinutuzumab) as a potential treatment for lupus nephritis (LN). A final decision is expected by October 2025.
The sNDA is supported by data from the late-stage REGENCY study, which evaluated Gazvya plus standard therapy in LN patients. Data from the study showed that patients who were treated with Gazvya combination therapy showed a complete renal response (CRR) benefit compared with those treated with standard therapy alone.
Roche intends to submit a similar regulatory filing for the drug with the EMA, which will also be supported by data from the REGENCY study. In the European Union (EU), the drug is marketed under the trade name Gazyvaro.
Gazyva/Gazyvaro is already approved in 100 countries, including the United States and the EU, for treating various types of lymphoma.
RHHBY Stock Performance
Year to date, shares of Roche have risen nearly 22% compared with the industry’s 12% growth.
Image Source: Zacks Investment Research
Gazvya: A Key Revenue Driver for Roche
Gazvya is one of Roche’s top-selling drugs. The drug has played an instrumental role in driving the company’s top line in the past few years. Roche added CHF910 million from the drug’s sales in 2024, indicating a 16% year-over-year improvement.
Apart from LN, Roche is also evaluating Gazyva in separate late-stage studies for membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus indications. Data from two of these studies is expected next year.
Estimates for Pacira’s 2025 earnings per share (EPS) have increased from $3.40 to $3.59 over the past 30 days. The estimate for 2026 has risen from $3.71 to $4.30. PCRX’s shares have surged 25% year to date.
Pacira’s earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 8.58%.
Estimates for argenx’s 2025 EPS have increased from $10.34 to $11.14 over the past 60 days. The estimate for 2026 has increased from $19.42 to $19.45. ARGX’s shares have gained 1% year to date.
argenx's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 345.11%.
Estimates for 89bio’s loss per share have narrowed from $2.66 to $2.40 for 2025 in the past 60 days. During the same time frame, the loss per share estimates for 2026 have improved from $3.06 to $2.75. ETNB’s shares have risen more than 8% year to date.
89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.
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FDA Accepts RHHBY's sNDA for Gazyva in Treating Lupus Nephritis
Roche (RHHBY - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its blockbuster drug Gazvya (obinutuzumab) as a potential treatment for lupus nephritis (LN). A final decision is expected by October 2025.
The sNDA is supported by data from the late-stage REGENCY study, which evaluated Gazvya plus standard therapy in LN patients. Data from the study showed that patients who were treated with Gazvya combination therapy showed a complete renal response (CRR) benefit compared with those treated with standard therapy alone.
Roche intends to submit a similar regulatory filing for the drug with the EMA, which will also be supported by data from the REGENCY study. In the European Union (EU), the drug is marketed under the trade name Gazyvaro.
Gazyva/Gazyvaro is already approved in 100 countries, including the United States and the EU, for treating various types of lymphoma.
RHHBY Stock Performance
Year to date, shares of Roche have risen nearly 22% compared with the industry’s 12% growth.
Image Source: Zacks Investment Research
Gazvya: A Key Revenue Driver for Roche
Gazvya is one of Roche’s top-selling drugs. The drug has played an instrumental role in driving the company’s top line in the past few years. Roche added CHF910 million from the drug’s sales in 2024, indicating a 16% year-over-year improvement.
Apart from LN, Roche is also evaluating Gazyva in separate late-stage studies for membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus indications. Data from two of these studies is expected next year.
RHHBY’s Zacks Rank
Roche currently carries a Zacks Rank #3 (Hold).
Roche Holding AG Price
Roche Holding AG price | Roche Holding AG Quote
Our Key Picks Among Biotech Stocks
Some better-ranked stocks are Pacira BioSciences (PCRX - Free Report) , argenx (ARGX - Free Report) and 89bio (ETNB - Free Report) . While PCRX sports a Zacks Rank #1 (Strong Buy), ARGX and ETNB carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Pacira’s 2025 earnings per share (EPS) have increased from $3.40 to $3.59 over the past 30 days. The estimate for 2026 has risen from $3.71 to $4.30. PCRX’s shares have surged 25% year to date.
Pacira’s earnings beat estimates in three of the trailing four quarters and missed the mark on one occasion, delivering an average surprise of 8.58%.
Estimates for argenx’s 2025 EPS have increased from $10.34 to $11.14 over the past 60 days. The estimate for 2026 has increased from $19.42 to $19.45. ARGX’s shares have gained 1% year to date.
argenx's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 345.11%.
Estimates for 89bio’s loss per share have narrowed from $2.66 to $2.40 for 2025 in the past 60 days. During the same time frame, the loss per share estimates for 2026 have improved from $3.06 to $2.75. ETNB’s shares have risen more than 8% year to date.
89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.