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Roche Holding AG (RHHBY) is a global pioneer in biotechnology and diagnostics, driving innovations in personalized healthcare through groundbreaking pharmaceuticals and advanced diagnostic solutions. This dedicated news hub provides investors and industry professionals with timely updates on corporate developments, research breakthroughs, and strategic initiatives shaping modern medicine.
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Roche has received CE certification for its updated cobas 6800/8800 systems 2.0, marking a significant advancement in molecular diagnostic testing. The upgrade enhances laboratory efficiency through increased throughput, improved run flexibility, and sample prioritization capabilities. A key feature is the new Temperature-Activated Generation of Signal (TAGS) technology, enabling simultaneous detection of up to 15 targets in a single patient sample.
The systems are designed for mid-to-high volume molecular testing laboratories, offering intelligent workflows and enhanced testing capabilities. The majority of the cobas test menu is available with this update, which can be implemented as an upgrade to existing systems worldwide. FDA submission for U.S. 510(k) clearance is planned for 2025.
Roche presented new data for its CD20xCD3 bispecific antibodies Columvi and Lunsumio at ASH 2024, demonstrating durable remissions with fixed-duration treatment. Three-year follow-up showed Columvi achieved 40% complete response in large B-cell lymphoma, while Lunsumio showed 64% of follicular lymphoma patients remained progression-free at 45 months.
A new subcutaneous formulation of Lunsumio demonstrated non-inferiority to intravenous treatment, with 76.6% overall response rate and 61.7% complete response rate. Real-world data indicated reduced treatment-related travel burden due to less frequent dosing with these therapies.
The combination of Lunsumio with Polivy showed improved efficacy versus MabThera/Rituxan with Polivy in relapsed/refractory large B-cell lymphoma, achieving 77.5% overall response rate versus 50%.
Genentech presented new data at ASH 2024 for its CD20xCD3 bispecific antibodies Columvi and Lunsumio in lymphoma treatment. Long-term follow-up data showed durable remissions with fixed-duration treatment, with Columvi achieving 40% complete response in large B-cell lymphoma and Lunsumio showing 64% of follicular lymphoma patients remaining progression-free at 45 months.
A new subcutaneous formulation of Lunsumio demonstrated non-inferiority to intravenous treatment, with 76.6% overall response rate and 61.7% complete response rate. Real-world data indicated reduced treatment-related travel burden due to less frequent dosing schedules. The combination of Lunsumio with Polivy showed improved efficacy versus Rituxan-Polivy combination in relapsed/refractory large B-cell lymphoma.
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.
