Roche Hldg Stock Price, News & Analysis

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.

Roche (OTCQX: RHHBY) has achieved a significant milestone as its Ionify® 25-Hydroxy Vitamin D total assay becomes the first mass spectrometry-based test to receive CLIA 'Moderate Complexity' designation from the FDA. The test runs on the cobas® i 601 analyzer, part of the cobas® Mass Spec solution.

This breakthrough enables broader access to advanced testing across routine clinical laboratories, moving beyond traditionally specialized labs. The system offers a fully automated, standardized workflow that combines mass spectrometry's sensitivity with improved efficiency. This is the first in Roche's planned U.S. pipeline for the cobas® Mass Spec solution, with additional launches expected globally.

Roche (OTCQX: RHHBY) has announced a definitive merger agreement to acquire 89bio for US$14.50 per share in cash, plus a contingent value right (CVR) of up to US$6.00 per share, representing a total potential deal value of US$3.5 billion.

The acquisition centers on pegozafermin, 89bio's phase 3 FGF21 analog designed to treat moderate to severe Metabolic Dysfunction-Associated Steatohepatitis (MASH). The deal strengthens Roche's cardiovascular, renal, and metabolic diseases portfolio, with pegozafermin positioned as a potential best-in-disease treatment for MASH patients with moderate to severe liver fibrosis.

The transaction is expected to close in Q4 2025, with CVR payments tied to three milestones: first commercial sale in F4 MASH patients, annual sales reaching US$3.0 billion, and annual sales reaching US$4.0 billion.

Roche (OTCQX:RHHBY) has received CE Mark approval for the integration of its Accu-Chek SmartGuide Continuous Glucose Monitoring (CGM) with the mySugr diabetes management app. The integrated solution combines AI-enabled predictive CGM technology with one of the world's most popular diabetes apps, which has over 6 million registered accounts.

The Accu-Chek SmartGuide CGM system can predict glucose levels up to two hours ahead and overnight for up to seven hours. Clinical evaluations demonstrated high system accuracy with a MARD of 9.2%. Real-world data showed the Night Low Predict feature reduced Level 1 hypoglycemic events by 20% and Level 2 hypoglycemia by 31%.

Currently available in 13 countries, Roche plans to expand access to over 30 countries across Europe, Latin America, and Asia-Pacific by year-end 2025.