Roche Hldg Stock Price, News & Analysis

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.

Roche (OTCQX:RHHBY) has announced promising new data for Vabysmo (faricimab) from two significant studies presented at the 25th Euretina Congress. The AVONELLE-X study, the largest long-term extension trial in neovascular age-related macular degeneration (nAMD), demonstrated sustained efficacy and safety over 4 years, with nearly 80% of patients achieving extended dosing intervals of 3-4 months.

The SALWEEN study showed impressive results in treating polypoidal choroidal vasculopathy (PCV), a difficult-to-treat form of nAMD. Key outcomes include complete resolution of lesions in over 60% of patients and clinically meaningful vision improvements of 8.9 letters in best-corrected visual acuity. More than 50% of patients achieved extended five-month dosing schedules.

Vabysmo has now reached over 8 million doses distributed globally and is approved in more than 100 countries for various eye conditions.

Genentech (OTCQX:RHHBY), a Roche Group company, has presented new data reinforcing the long-term efficacy of Vabysmo in treating wet age-related macular degeneration (AMD). The AVONELLE-X study demonstrated sustained disease control over 4 years, with nearly 80% of patients achieving extended dosing intervals of 3-4 months.

In the SALWEEN study, focusing on polypoidal choroidal vasculopathy (PCV), a difficult-to-treat form of wet AMD, patients showed significant improvements. Over 60% of participants experienced complete resolution of damaging lesions, and patients gained an average of 8.9 letters in visual acuity. More than 50% of patients qualified for extended five-month dosing schedules.

Vabysmo has maintained a consistent safety profile and is now approved in over 100 countries for various eye conditions, with more than 8 million doses distributed globally since its 2022 U.S. approval.

Roche (OTCQX:RHHBY) has received CE IVDR approval for two significant label expansions of its VENTANA HER2 (4B5) companion diagnostic test. The test is now the first and only diagnostic approved for two key indications: identifying HER2-ultralow metastatic breast cancer patients eligible for ENHERTU treatment, and detecting HER2-positive biliary tract cancer patients suitable for ZIIHERA therapy.

The expansion is particularly significant as approximately 20-25% of hormone receptor-positive, HER2-negative breast cancer patients may be classified as HER2-ultralow. The DESTINY-Breast06 trial demonstrated significant improvement in progression-free survival with ENHERTU in these patients. In Europe, over 564,000 people will be diagnosed with breast cancer this year, with more than 145,000 estimated deaths.

Roche (OTCQX:RHHBY) has received CE mark approval for Contivue, its Port Delivery Platform containing Susvimo, for treating neovascular age-related macular degeneration (nAMD). The platform consists of an eye implant and four ancillary devices for implant management.

New seven-year data from the LADDER study demonstrates strong efficacy, with patients maintaining stable vision and retinal anatomy. The study showed only a six-letter decline in best-corrected visual acuity over seven years, with 95% durability maintained in patients.

The treatment requires only two refills per year, offering a significant improvement over current monthly intravitreal injections. Susvimo is currently under EMA review and could become the first continuous delivery treatment for nAMD, which affects 1.7 million people in the European Union.