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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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Bookmark this page for comprehensive tracking of Roche's progress in oncology, immunology, and molecular diagnostics. Stay informed about developments impacting one of healthcare's most influential innovators through verified updates from primary sources.
Roche (OTCQX: RHHBY) announced FDA approval on October 3, 2025 of Tecentriq (atezolizumab) plus lurbinectedin (Zepzelca) as the first‑line maintenance regimen for adults with extensive‑stage small cell lung cancer (ES‑SCLC) whose disease has not progressed after induction with Tecentriq (or Tecentriq Hybreza), carboplatin and etoposide.
The approval is based on phase III IMforte: the combination reduced risk of progression or death by 46% and risk of death by 27%. Median overall survival was 13.2 vs 10.6 months (HR=0.73; p=0.0174); median PFS was 5.4 vs 2.1 months (HR=0.54; p<0.0001). Safety matched known profiles. NCCN updated the regimen to category 2A preferred for maintenance after Tecentriq+CE.
Roche (OTCQX: RHHBY) announced on 3 October 2025 that Dr. Claudia Süssmuth Dyckerhoff will not stand for re-election to the Roche Board at the 2026 Annual General Meeting. She has served on Roche's Board since March 2016 and will be nominated for election to the board of another company in the healthcare industry. Chairman Severin Schwan thanked her for a decade of contributions, citing her knowledge of healthcare and international market dynamics, particularly in Asia.
Genentech (RHHBY) announced on October 2, 2025 that the FDA approved Tecentriq (atezolizumab) plus lurbinectedin (Zepzelca) as the first‑line maintenance therapy for adult patients with extensive‑stage small cell lung cancer (ES‑SCLC) whose disease has not progressed after induction with Tecentriq (or Tecentriq Hybreza), carboplatin and etoposide.
The approval is based on Phase III IMforte: the combo reduced risk of progression or death by 46% (HR=0.54; PFS median 5.4 vs 2.1 months) and risk of death by 27% (HR=0.73; OS median 13.2 vs 10.6 months). Safety was consistent with known profiles. The regimen is added to NCCN Guidelines as a category 2A preferred maintenance option.
Roche (OTCQX: RHHBY) has initiated a tender offer to acquire all outstanding shares of 89bio (NASDAQ: ETNB). The offer includes $14.50 per share in cash plus a non-tradeable contingent value right (CVR) worth up to $6.00 per share in additional milestone payments.
The tender offer will expire on October 29, 2025, unless extended. The transaction, unanimously recommended by 89bio's board, is expected to close in Q4 2025. The deal is subject to standard closing conditions, including Hart-Scott-Rodino Act compliance and majority shareholder tender, but requires no financing contingency.
Roche (OTCQX: RHHBY) has announced significant results from its TSIX Study Program evaluating their new sixth-generation high-sensitivity Troponin T test for heart attack diagnosis. The study, involving over 13,000 participants, demonstrated the test's superior precision in identifying acute myocardial infarction (AMI) and ruling out non-cardiac cases.
The Elecsys® Troponin T hs Gen 6 test, which recently received CE Mark approval, addresses a critical healthcare need, as chest pain accounts for a significant portion of emergency visits, though only 10% of cases are actual heart attacks. With 49% of European emergency departments experiencing frequent overcrowding, this improved diagnostic tool enables more efficient patient triage and resource allocation.
Genentech (OTCQX:RHHBY) presented new data for its multiple sclerosis (MS) treatments at ECTRIMS 2025. The company showcased positive results for both Ocrevus and investigational drug fenebrutinib across diverse patient populations.
Key findings include: 30% reduction in disability progression risk for advanced PPMS patients treated with Ocrevus, rising to 55% in patients with MRI lesion activity. The two-year Ocrevus subcutaneous injection data confirmed consistent benefit-risk profile. Notably, 86-100% of infants exposed to Ocrevus during pregnancy and 78-100% during breastfeeding showed protective antibody responses to common vaccines.
For fenebrutinib, Phase II data demonstrated near-complete suppression of disease activity at 96 weeks, with a low annualized relapse rate of 0.06 and zero new T1 gadolinium-enhancing lesions.
Roche (OTCQX:RHHBY) presented new clinical data for OCREVUS and fenebrutinib at ECTRIMS 2025. The data demonstrates significant advances in multiple sclerosis (MS) treatment across diverse patient populations.
Key highlights include: OCREVUS showing 30% reduction in disability progression risk for advanced PPMS patients, with an increased 55% reduction in patients with MRI lesion activity. The OCREVUS subcutaneous injection maintained consistent benefits for two years, while pregnancy registry data from over 5,000 pregnancies confirmed safety for pregnant and breastfeeding women.
Additionally, fenebrutinib demonstrated promising results with near-complete suppression of disease activity at 96 weeks in Phase II trials, showing a low annualized relapse rate of 0.06 and no disability progression.
Genentech (OTCQX:RHHBY) announced positive Phase III results from the evERA study evaluating giredestrant plus everolimus in ER-positive, HER2-negative advanced breast cancer patients previously treated with CDK4/6 inhibitor and endocrine therapy.
The trial met its co-primary endpoints, demonstrating statistically significant improvement in progression-free survival in both intention-to-treat and ESR1-mutated populations compared to standard-of-care plus everolimus. While overall survival data were immature, a positive trend was observed. The all-oral combination was well-tolerated with no new safety signals.
This marks the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor degrader-containing regimen versus standard of care combination. The company plans to submit data to health authorities for approval.
Roche (OTCQX: RHHBY) announced positive Phase III results from the evERA study evaluating giredestrant plus everolimus in ER-positive, HER2-negative advanced breast cancer patients previously treated with CDK4/6 inhibitor and endocrine therapy.
The trial met both co-primary endpoints, showing statistically significant and clinically meaningful improvement in progression-free survival in both intention-to-treat and ESR1-mutated populations compared to standard-of-care plus everolimus. While overall survival data were immature, a clear positive trend was observed.
This marks the first positive head-to-head phase III trial investigating an all-oral selective oestrogen receptor degrader-containing regimen versus standard of care. The combination was well-tolerated with no new safety signals observed.
Roche (OTCQX: RHHBY) has received a CHMP recommendation for EU approval of a subcutaneous formulation of Lunsumio for treating adult patients with relapsed or refractory follicular lymphoma. The new formulation significantly reduces administration time to approximately one minute compared to 2-4 hours for IV infusion.
The recommendation is based on the phase II GO29781 study, which demonstrated pharmacokinetic non-inferiority to IV administration. Key safety data showed a low rate of cytokine release syndrome (29.8%), with mostly low-grade events. The treatment offers a fixed duration of 6-12 months and can be administered in outpatient settings.
Notably, Lunsumio has shown high and long-lasting response rates, with about two-thirds of patients maintaining complete response remission after four years.