http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Wed, 15 Jul 2026 01:01:48 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html <p>Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), said the U.S. Food and Drug Administration has granted priority review to a supplemental Biologics License Application for Gazyva (obinutuzumab) as a treatment for primary membranous nephropathy, a chronic autoimmune kidney disease that currently has no FDA-approved therapies.</p> <p>The priority review is based on results from the Phase III MAJESTY study, in which 36.9% of adults treated with Gazyva achieved complete remission at two years compared with 5.7% of those treated with tacrolimus, an immunosuppressive therapy. The FDA is expected to make an approval decision by November 2026.</p> <p>The FDA http://www.streetinsider.com/FDA/FDA+grants+priority+review+to+Genentech%27s+Gazyva+for+kidney+disease/26769583.html Wed, 15 Jul 2026 01:01:48 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html <ul class="bwlistdisc"> <li> <i>Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus</i> </li> <li> <i>If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome</i> </li> <li> <i>pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years</i> </li> </ul> <p> SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROP; http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+to+Genentech%E2%80%99s+Gazyva+for+Adults+With+Primary+Membranous+Nephropathy/26769582.html Wed, 15 Jul 2026 01:00:00 -0400 A.06822034 A.31066700 A.40151759 O.00050368 O.00222322 O.20026344 O.22422661 RHHBY RO ROP