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Roche Holdings Ltd. S/ADR (RHHBY) is a leading biotechnology company with a global presence in the field of in-vitro diagnostics. Roche focuses on scientific excellence to develop medicines and diagnostics for improving and saving lives. The company's pivotal role in personalized healthcare is reflected in its commitment to transforming healthcare delivery. Roche's innovative approach encompasses the discovery and development of cutting-edge treatments, including the first CD20xCD3 bispecific antibody, Columvi® (glofitamab), for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The company's recently FDA-cleared whole-slide imaging system, VENTANA DP 200, signifies Roche's dedication to revolutionizing pathology workflows through digitalization and artificial intelligence-based tools, ensuring pathologists can provide accurate and timely diagnoses. Roche's extensive portfolio and pipeline of haematology medicines demonstrate its unwavering commitment to advancing treatment options for patients worldwide.
Roche has initiated a tender offer to acquire all outstanding shares of Poseida Therapeutics for $9.00 per share in cash, plus a non-tradeable contingent value right (CVR) worth up to an additional $4.00 per share. The tender offer, announced on December 9, 2024, will expire on January 7, 2025, unless extended.
The acquisition follows a merger agreement dated November 25, 2024. The transaction requires regulatory approvals and the tender of a majority of Poseida's outstanding shares. After successful completion of the tender offer, remaining shares will be acquired through a second-step merger at the same terms. The deal is expected to close in Q1 2025.
Roche announced five-year follow-up data from the phase III POLARIX study evaluating Polivy combination therapy in untreated diffuse large B-cell lymphoma (DLBCL). The analysis showed a positive trend in overall survival with Polivy plus R-CHP compared to R-CHOP, with a reduction in death risk (HR 0.85). The study demonstrated that patients receiving Polivy combination needed nearly 25% fewer follow-up treatments compared to standard therapy.
The safety profile remained consistent with no new safety signals, and benefits in progression-free and disease-free survival were maintained. The treatment showed a numerical reduction in lymphoma-related deaths (9.0% vs 11.4%). More than 38,000 people worldwide have been treated with this combination, which is now approved in over 90 countries.
Genentech announced five-year follow-up data from the Phase III POLARIX study evaluating Polivy in combination with R-CHP for untreated diffuse large B-cell lymphoma (DLBCL). The analysis showed a positive trend in overall survival with a reduction in death risk (HR 0.85) compared to standard R-CHOP therapy.
Key findings include nearly 25% fewer follow-up treatments needed in the Polivy combination group, maintained benefits in progression-free and disease-free survival, and a numerical reduction in lymphoma-related deaths (9.0% vs 11.4%). The safety profile remained consistent with no new signals.
The treatment is currently approved in over 90 countries, with more than 38,000 patients treated worldwide. Genentech continues exploring Polivy combinations through additional Phase III trials SUNMO and SKYGLO.
Roche announced FDA acceptance of a supplemental Biologics License Application (sBLA) for Columvi in combination with gemcitabine and oxaliplatin (GemOx) for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients. The application is based on the phase III STARGLO study, which demonstrated significant overall survival improvement compared to standard treatment.
The FDA decision is expected by July 20, 2025. The treatment targets patients who have received at least one prior therapy and are ineligible for stem cell transplant. The study results showed Columvi combination therapy to be the first CD20xCD3 bispecific antibody demonstrating survival benefits in DLBCL in a randomized phase III trial.
Genentech announced FDA acceptance of a supplemental Biologics License Application (sBLA) for Columvi in combination with gemcitabine and oxaliplatin (GemOx) for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The application is based on the Phase III STARGLO study, which demonstrated statistically significant improvement in overall survival compared to Rituxan with GemOx.
The FDA decision is expected by July 20, 2025. This treatment could provide an off-the-shelf, fixed-duration option for patients who aren't eligible for stem cell transplant. Columvi is currently approved in over 50 countries as a monotherapy for R/R DLBCL after two or more lines of systemic therapy.
Roche has announced a definitive merger agreement to acquire Poseida Therapeutics for US $9.00 per share in cash, with a total equity value of approximately US $1.0 billion. Stockholders will receive an additional non-tradeable contingent value right (CVR) of up to US $4.00 per share, potentially bringing the total deal value to US $1.5 billion. The acquisition, expected to close in Q1 2025, builds on their existing 2022 partnership and focuses on developing off-the-shelf CAR-T cell therapies. Poseida's portfolio includes pre-clinical and clinical-stage therapies for hematological malignancies, solid tumors, and autoimmune diseases, along with manufacturing capabilities and technology platforms.
Roche reports that the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® versus Tecentriq alone in PD-L1-high non-small cell lung cancer (NSCLC) patients, did not meet its primary endpoint of overall survival at final analysis. The global, randomized, double-blind study involved 534 patients with previously untreated, locally advanced unresectable or metastatic NSCLC. The safety profile remained consistent with longer follow-up, showing no new safety signals. Detailed data will be presented at a medical meeting in 2025.
Genentech announces that its Phase III SKYSCRAPER-01 study, testing tiragolumab combined with Tecentriq versus Tecentriq alone in PD-L1-high non-small cell lung cancer (NSCLC) patients, did not meet its primary endpoint of overall survival. The global, randomized, double-blinded study involved 534 previously untreated patients with locally advanced unresectable or metastatic NSCLC. While the safety profile remained consistent with no new signals identified, detailed data will be presented at a medical meeting in 2025. The company plans to review its study programs and expects additional Phase III data across different settings next year.
Roche has received FDA approval for its PATHWAY HER2 (4B5) test as the first companion diagnostic for identifying biliary tract cancer (BTC) patients eligible for HER2-targeted treatment with ZIIHERA. The test helps identify patients with previously-treated, unresectable or metastatic HER2-positive BTC who may benefit from ZIIHERA treatment. This represents a significant advancement as BTC has treatment options, with most cases diagnosed at advanced stages. The test's approval expands its clinical utility and provides a standardized method for identifying eligible patients for targeted therapy. BTC accounts for 3% of gastrointestinal cancers in the US, with a five-year survival rate of only 19% for localized disease and 3% for metastatic cases.
Roche has received CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry companion diagnostic test in Europe for identifying epithelial ovarian cancer patients eligible for ELAHERE treatment. The test detects folate receptor 1 protein, expressed in about 90% of ovarian carcinomas. This certification follows an early exemption approval in Germany and Austria earlier this year. The test aims to enable more precise treatment decisions for ovarian cancer, which causes 46,232 deaths annually in Europe and is the eighth leading cause of cancer death in women worldwide.