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22.12.2025
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FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or m...
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19.12.2025
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Genentech Announces Agreement With U.S. Government
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced an agreement with the U.S. government that lowers costs for state Medicaid programs, encourages other wealthy countries to reward innovation, and increases opportunities for direct patient access.
Under this agreement, Genentech is making commitments that address all f...
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16.12.2025
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Roche announces U.S. launch of next-generation cobas 6800/8800 systems and software, enhancing laboratory efficiency and testing capabilities
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The new cobas® 6800/8800 Systems version 2.0 and software version 2.0.1 enhances throughput, run flexibility, enables sample prioritization and is available as an upgrade to existing systems.Laboratories can now perform a greater variety of tests per run, simplifying laboratory logistics and helping to optimize the use of resources.The update addr...
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Worth to know
20.10.2025
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10.12.2025
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Genentech’s Giredestrant Reduced Risk of Invasive Disease Recurrence or Death by 30% in ER-positive Early-Stage Breast Cancer
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive data from the Phase III lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer. At...
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20.10.2025
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08.12.2025
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Genentech Presents Lunsumio Data Showing Potential Across Earlier Treatment Lines in Indolent and Aggressive Lymphomas
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data highlighting the potential of Lunsumio® (mosunetuzumab-axgb) in earlier treatment lines for people living with different types of lymphoma, presented at the 67th American Society of Hematology Annual Meeting and Exposition, December 6-9, 2025 in Orlando,...
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18.11.2025
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Genentech’s Giredestrant Becomes the First Oral SERD to Show Superior Invasive Disease-Free Survival in Early Breast Cancer
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive Phase III results from the lidERA Breast Cancer study evaluating investigational giredestrant as an adjuvant endocrine treatment for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, early-stage breast...
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12.11.2025
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Millennials at highest risk of missing crucial cervical cancer screenings, finds survey commissioned by Roche
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New research shows that people aged 29-42 are more likely to miss cervical screenings than any other age group.1
Almost one third of surveyed European millennials eligible for routine cervical screening have postponed or skipped their...
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10.11.2025
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Genentech’s Fenebrutinib Shows Unprecedented Positive Phase III Results as the Potential First and Only BTK Inhibitor in Both Relapsing and Primary Progressive Multiple Sclerosis
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the first Phase III (FENhance 2) of two pivotal, similarly-designed Phase III studies (FENhance 1 and 2) in patients with relapsing multiple sclerosis (RMS) met its primary endpoint. Fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, s...
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03.11.2025
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Genentech to Present New Data From Its Broad and Innovative Hematology Portfolio at ASH 2025
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading hematology portfolio at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 6-9, 2025 in Orlando, Florida.
“The data we will pre...
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03.11.2025
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Positive Phase III Data for Genentech’s Gazyva Show Significant Reduction in Disease Activity for Systemic Lupus Erythematosus
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today statistically significant and clinically meaningful results from the Phase III ALLEGORY study of Gazyva® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) on standard therapy. The study met its primary endpoint showing a higher percentage of people...
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28.10.2025
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Positive Phase III Results for Genentech’s Gazyva in Children and Young Adults With Idiopathic Nephrotic Syndrome
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today statistically significant and clinically meaningful results from the Phase III INShore study of Gazyva® (obinutuzumab) in children and young adults (aged ≥ 2-25 years) with idiopathic nephrotic syndrome (INS). The study met its primary endpoint, with more people ac...
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20.10.2025
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Genentech’s Tecentriq Showed Significant Overall and Disease-Free Survival Benefits in Bladder Cancer With ctDNA-Guided Treatment
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III IMvigor011 study evaluating Tecentriq® (atezolizumab) as an adjuvant treatment for people with muscle-invasive bladder cancer (MIBC) who are at risk of recurrence after surgery (cystectomy) and have detectable circulating tumor...
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20.10.2025
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20.10.2025
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FDA Approves Genentech’s Gazyva for the Treatment of Lupus Nephritis
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for...
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18.10.2025
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Genentech’s Phase III evERA Data Showed Giredestrant Significantly Improved Progression-Free Survival in People With ER-Positive Advanced Breast Cancer
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III evERA Breast Cancer study. Data showed giredestrant in combination with everolimus significantly reduced the risk of disease progression or death (progression-free survival; PFS) by 44% and 62% in the intention-to-treat (ITT) an...
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17.10.2025
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Genentech Presents New Phase III Pivotal Data for Vamikibart in Uveitic Macular Edema (UME), a Serious Cause of Vision Loss
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today results from two Phase III studies evaluating the efficacy and safety of two doses of investigational vamikibart (0.25 and 1 mg) compared with a sham procedure that mimics intravitreal (IVT) injections in people with uveitic macular edema (UME). UME is characteriz...
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16.10.2025
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Genentech Expands Xofluza® Access and Affordability for Upcoming Flu Season With Direct-to-Patient Launch
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the company’s first Direct-to-Patient (DTP) program. This program, which supports President Trump’s goal to make medicines more affordable for American patients, applies to Xofluza® (baloxavir marboxil), a single-dose oral antiviral medication used to treat the fl...
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13.10.2025
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Genentech Data at ESMO 2025 Showcase Advances in Science and Cancer Care Across Multiple Tumor Types
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it will present more than 30 abstracts across more than 10 cancer types at the European Society for Medical Oncology (ESMO) Congress 2025, held October 17-21, 2025 in Berlin, Germany. The data underscore Genentech’s commitment to deliver transformative medici...
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03.10.2025
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FDA Approves Genentech’s Tecentriq Plus Lurbinectedin as First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adult patients with extensive-stage...
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24.09.2025
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Genentech Presents New Data for Ocrevus and Fenebrutinib Across Broad Patient Populations at ECTRIMS 2025
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presents new data for Ocrevus® (ocrelizumab) and the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain (September 24-26).
New data s...
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22.09.2025
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Positive Phase III Results Show Genentech’s Giredestrant Significantly Improved Progression-Free Survival in ER-positive Advanced Breast Cancer
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III evERA study evaluating investigational giredestrant in combination with everolimus in people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast c...
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18.09.2025
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Roche achieves first CLIA 'Moderate Complexity' categorization for Ionify® 25-Hydroxy Vitamin D total test
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First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S.Expands access to advanced testing with a fully automated, standardized workflow on the cobas® i 601 analyzerMarks an important step in broadening the clinical utility of mass spectrometry testing across routine lab...
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05.09.2025
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New Data for Genentech’s Vabysmo Reinforce Its Efficacy, Safety and Durability in Wet Age-Related Macular Degeneration (AMD)
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data from the AVONELLE-X and SALWEEN studies of Vabysmo® (faricimab-svoa), presented at the 25th Euretina Congress in Paris, France. Data from the open-label AVONELLE-X study reinforce the efficacy, safety and durability of Vabysmo over four years in wet age-r...
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05.09.2025
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Roche receives CE IVDR approval for HER2 (4B5) companion diagnostic test to identify HER2-ultralow breast cancer and biliary tract cancer patients
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The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in the assessment of HER2-ultralow status to identify metastatic breast cancer patients who may be eligible for treatment with ENHERTU.The VENTANA HER2 (4B5) test is also now approved to help identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract...
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05.09.2025
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Roche receives CE IVDR approval for HER2 (4B5) companion diagnostic test to identify HER2-ultralow breast cancer and biliary tract cancer patients
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The VENTANA HER2 (4B5) test is now CE-IVDR approved to aid in the assessment of HER2-ultralow status to identify metastatic breast cancer patients who may be eligible for treatment with ENHERTU.The VENTANA HER2 (4B5) test is also now approved to help identify patients with previously-treated, unresectable or metastatic HER2-positive biliary tract...
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30.08.2025
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Genentech and Alnylam Advance Zilebesiran Into Global Phase III Cardiovascular Outcomes Trial for People With Uncontrolled Hypertension
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam (Nasdaq: ALNY) today announced the decision to initiate a Phase III cardiovascular outcomes trial (CVOT) to evaluate the ability of zilebesiran, an RNAi therapeutic, to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension. T...
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25.08.2025
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Genentech and Roche Break Ground on State-of-the-Art Manufacturing Facility in Holly Springs, North Carolina
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today broke ground on its newest U.S. manufacturing site in Holly Springs, North Carolina. This significant development marks the establishment of Genentech’s first manufacturing facility on the East Coast. The 700,000-square-foot facility is strategically designed to support pro...
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01.08.2025
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Genentech’s Susvimo Maintains Vision Over Five Years With Two Refills Per Year in People With Wet Age-Related Macular Degeneration (AMD)
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new, five-year efficacy, safety and durability data from the Phase III Portal study, a long-term extension of the Phase III Archway study, of Susvimo® (ranibizumab injection) for the treatment of people with wet AMD. Results show that Susvimo’s immediate and predi...
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28.07.2025
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Genentech and Roche Present New Insights in Alzheimer’s Disease Research Across Its Diagnostics and Pharmaceutical Portfolios at AAIC
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data from its Alzheimer’s development portfolio is being presented at the Alzheimer’s Association International Conference (AAIC) in Toronto, Canada (July 27-30). These data exemplify the comprehensive approach Roche is taking in addressing Alzheimer’s acr...
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24.07.2025
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Roche Diagnostics showcases science-driven leadership and innovation at ADLM 2025
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Lead With Us -- a promise for innovative partnerships, better insights, faster support, and improved healthcare outcomes.
INDIANAPOLIS and CHICAGO, July 24, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) will showcase its science-driven leadership in diagnostics at the 2025 Association for Diagnostics & Laboratory Medicine (ADLM) Sci...
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21.07.2025
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Genentech Provides Update on Astegolimab in Chronic Obstructive Pulmonary Disease
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today topline results from the pivotal Phase IIb ALIENTO (n=1,301) and the Phase III ARNASA (n=1,375) trials investigating astegolimab compared to placebo, on top of standard of care maintenance therapy in people with moderate to very severe chronic obstructive pulmonar...
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18.07.2025
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Genentech Provides Update on Supplemental Biologics License Application for Columvi Combination for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Genentech’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of p...
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20.06.2025
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Genentech’s Lunsumio and Polivy Combination Significantly Prolongs Remission for People With Relapsed or Refractory Large B-cell Lymphoma
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today results from the Phase III SUNMO [NCT05171647] study showing Lunsumio® (mosunetuzumab-axgb) administered subcutaneously in combination with Polivy® (polatuzumab vedotin-piiq) demonstrated a clinically meaningful and statistically significant improvement in its pri...
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16.06.2025
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Genentech Provides Update on Phase III Verona Study
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and AbbVie announced today the outcome from the Phase III VERONA study (NCT04401748) investigating Venclexta® (venetoclax) plus azacitidine for patients with previously untreated higher-risk myelodysplastic syndromes (MDS). The study did not meet the primary endpoint of overall s...
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16.06.2025
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Genentech to Advance Prasinezumab Into Phase III Development for Early-Stage Parkinson’s Disease
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today its decision to proceed with Phase III development of prasinezumab, an investigational anti-alpha-synuclein antibody, in early-stage Parkinson’s disease. This decision is informed by data from the Phase IIb PADOVA study and ongoing open-label extensions (OLEs) of...
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02.06.2025
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Genentech’s Tecentriq Combined with Lurbinectedin Shows Significant Survival Benefit in Extensive-Stage Small Cell Lung Cancer
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase III IMforte study of Tecentriq® (atezolizumab) in combination with lurbinectedin (Zepzelca®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with car...
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31.05.2025
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New Data Show Genentech’s Itovebi Significantly Extended Survival in a Certain Type of HR-positive Advanced Breast Cancer
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive final results from the overall survival (OS) analysis of the Phase III INAVO120 study. These data showed ItovebiTM (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, reduced the risk of death by more than 30% compared with palbocicl...
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30.05.2025
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Genentech’s Fenebrutinib Maintains Near-Complete Suppression of Disease Activity and Disability Progression for up to Two Years in People With Relapsing Multiple Sclerosis
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. The latest results for this investigational Bruton’s tyrosine kinase...
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23.05.2025
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New Two-year Follow-up of Genentech’s Columvi Extends Overall Survival in Relapsed or Refractory Diffuse Large B-cell Lymphoma Patients
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today two-year follow-up data from the Phase III STARGLO study. After a median follow-up of 24.7 months, data showed a 40% improvement in overall survival (OS) for patients treated with Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) a...
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22.05.2025
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FDA Approves Genentech’s Susvimo for Diabetic Retinopathy
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic retinopathy (DR), a potentially blinding condition that affects almost 10 million people in the U.S. and more than 100 million peo...
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20.05.2025
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Genentech Provides Update on FDA Advisory Committee Meeting on Columvi Combination for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) discussed the supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of peo...
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13.05.2025
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Ten-Year APHINITY Data Show Genentech’s Perjeta-based Regimen Reduced the Risk of Death by 17% in HER2-Positive Early-Stage Breast Cancer
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), the Breast International Group (BIG), Institut Jules Bordet Clinical Trials Support Unit and Frontier Science Foundation, announced today statistically significant final overall survival (OS) results from the Phase III APHINITY study in people with human epidermal growth factor r...
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12.05.2025
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Roche announces $550 million investment to expand its Indianapolis diagnostics manufacturing hub
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An investment of up to $550 million by 2030 will establish the Indianapolis site as a hub for manufacturing of Roche's continuous glucose monitoring solution.Expansion will create hundreds of jobs while also enhancing U.S. production capabilities.Increased access to diabetes management tools will help improve health outcomes for patients in the U...
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12.05.2025
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Roche and Genentech Announce New North Carolina Manufacturing Facility
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today plans to invest more than $700 million in a new 700,000 square foot state-of-the-art drug manufacturing facility in Holly Springs, NC.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250512172766/en/
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25.04.2025
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New England Journal of Medicine Publishes Phase III Data Showing Single-dose Xofluza Significantly Reduces Influenza Virus Transmission
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the New England Journal of Medicine (NEJM) has published a detailed analysis of the Phase III CENTERSTONE trial of Xofluza® (baloxavir marboxil). The trial met its primary endpoint, showing a single, oral dose of Xofluza taken by people infected with influenza...
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03.04.2025
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Genentech and Roche Present Novel Therapeutic and Diagnostic Advancements in Alzheimer’s at AD/PD 2025
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data were presented at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s Diseases in Vienna, Austria. Highlights included presentations from the ongoing trontinemab Phase Ib/IIa Brainshuttle™ AD study demonstrating dose-dependent rapi...
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02.04.2025
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Genentech Provides Update on Phase III Ocrevus High Dose Study in People With Relapsing Multiple Sclerosis
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase III MUSETTE trial comparing a high dose of Ocrevus® (ocrelizumab) intravenous (IV) infusion to the currently approved Ocrevus IV 600 mg dose in people with relapsing multiple sclerosis (RMS) did not meet its primary endpoint in showing additional be...
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05.03.2025
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FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of lupus nephritis. The filing acceptance is based on positive results from the Phase III REGE...
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03.03.2025
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FDA Approves Genentech’s TNKase® in Acute Ischemic Stroke in Adults
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved TNKase® (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults. This approval of TNKase marks Genentech’s second approval for stroke, reinfor...
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02.03.2025
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Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored Phase III OUtMATCH study, which provide further evidence supporting the role of Xolair® (omalizumab) for the treatment of one or more food allergies. Stage 2 of the OUt...
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12.02.2025
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FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® (risdiplam) tablet for people living with spinal muscular atrophy (SMA). Evrysdi is the only non-invasive disease-modifying treatment for SMA. The 5 mg Evrys...
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07.02.2025
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New England Journal of Medicine Publishes New Data for Genentech’s Gazyva Which Shows Superiority Over Standard Therapy in People With Active Lupus Nephritis
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that a detailed analysis of its Phase III REGENCY trial of Gazyva® (obinutuzumab) in people with active lupus nephritis (LN) was published in the New England Journal of Medicine. The trial demonstrated a statistically significant and clinically meaningful improvem...
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04.02.2025
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FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes, affecting more than 29 million adults worldwide. Susv...
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28.01.2025
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Genentech’s Itovebi Demonstrated Statistically Significant and Clinically Meaningful Overall Survival Benefit in a Certain Type of HR-Positive Advanced Breast Cancer
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline results from the overall survival (OS) analysis of the Phase III INAVO120 study investigating ItovebiTM (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant for people with PIK3CA-mutated, hormone receptor (HR)-positive, human e...
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13.01.2025
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Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma
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The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare provid...
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09.01.2025
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Roche's momentum in digital pathology continues with FDA clearance on its high-volume slide scanner
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The VENTANA DP 600 slide scanner, part of Roche's Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images.This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and work...
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19.12.2024
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Genentech’s Phase IIb Study of Prasinezumab Missed Primary Endpoint, but Suggests Possible Benefit in Early-Stage Parkinson’s Disease
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today results from the Phase IIb PADOVA study investigating prasinezumab in 586 people with early-stage Parkinson’s disease, treated for a minimum of 18 months while on stable symptomatic treatment. Prasinezumab showed potential clinical efficacy in the primary endpoint...
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10.12.2024
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New and Updated Data for Genentech’s Fixed-Duration Columvi and Lunsumio at ASH 2024 Reinforce Their Potential to Improve Outcomes for People With Lymphoma
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new and updated data from its industry-leading CD20xCD3 T-cell-engaging bispecific antibody program were presented at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, 2024. With more than 20 bispecific antibody abs...
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08.12.2024
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Five-Year Results Confirm Genentech’s Polivy Combination Therapy as New Standard of Care for Previously Untreated Aggressive Lymphoma
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from a five-year follow-up of the pivotal Phase III POLARIX study evaluating Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with untreated diffuse large B-cell lympho...
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05.12.2024
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FDA Accepts Supplemental Biologics License Application for Genentech’s Columvi Combination for People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refrac...
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26.11.2024
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Genentech Reports Update on Phase III SKYSCRAPER-01 Study Results
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reports an update on the Phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC).
SKYSCRAPER-01 is a global Phase II...
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