Roche Hldg Stock Price, News & Analysis

Roche (RHHBY) has received FDA approval for its VENTANA MET (SP44) RxDx Assay, marking it as the first companion diagnostic test to identify non-squamous non-small cell lung cancer (NSQ-NSCLC) patients eligible for AbbVie's Emrelis treatment. The assay detects MET protein expression, a crucial biomarker for determining patient response to c-Met-targeted therapy.

The approval is backed by the Phase 2 LUMINOSITY study, which demonstrated a 35% overall response rate and 7.2 months median duration of response in patients with high c-Met protein expression treated with Emrelis. This development is particularly significant as approximately 25% of advanced NSCLC patients with normal EGFR genes show high MET protein levels.

Roche announced significant 10-year final overall survival results from the phase III APHINITY study for HER2-positive early-stage breast cancer treatment. The study showed that combining Perjeta (pertuzumab) with Herceptin (trastuzumab) and chemotherapy reduced death risk by 17% compared to Herceptin, chemotherapy, and placebo. Key findings include:

- 91.6% survival rate at 10 years with Perjeta-based regimen vs 89.8% with standard treatment - 21% reduction in death risk for patients with lymph node-positive disease - Maintained invasive disease-free survival benefit - No benefit observed in node-negative subgroup - Consistent safety profile with no new concerns

The results validate the Perjeta-based regimen as a standard-of-care treatment in the curative setting, particularly beneficial for high-risk patients with lymph-node positive disease.

Genentech announced significant 10-year final overall survival results from the Phase III APHINITY study for HER2-positive early-stage breast cancer. The study showed that adding Perjeta (pertuzumab) to Herceptin and chemotherapy as post-surgery treatment reduced death risk by 17% compared to Herceptin, chemotherapy, and placebo. After 10 years, 91.6% of patients on the Perjeta-based regimen survived versus 89.8% in the control group. Notably, patients with lymph node-positive disease showed a 21% reduction in death risk. The safety profile remained consistent with previous studies, with no new safety concerns identified. The previously reported invasive disease-free survival benefit was maintained, though no benefit was observed in the node-negative subgroup.

Roche (RHHBY) has announced a significant $550 million investment to expand its Indianapolis diagnostics manufacturing facility by 2030. The expansion will transform the site into a major hub for manufacturing continuous glucose monitoring (CGM) systems. The Indianapolis campus, which currently produces 5.2 billion Accu-Chek® diabetes test strips annually, will see enhanced capabilities to serve both U.S. and global markets across 53 countries.

The investment aims to address the needs of over 38 million Americans living with diabetes by improving access to diabetes management solutions. The expansion will create hundreds of manufacturing jobs and thousands of construction positions, boosting Indiana's economy while strengthening domestic production capabilities. This investment builds upon Roche's previous $800 million investment in U.S. operations since 2015.

Roche and Genentech have announced plans to invest over $700 million in a new state-of-the-art manufacturing facility in Holly Springs, North Carolina. The 700,000 square foot facility will be Genentech's first East Coast manufacturing site, focusing on next-generation obesity medicines. The project will create 400+ high-wage manufacturing jobs once operational and 1,500+ construction jobs during development.

The investment could potentially expand based on business needs and U.S. policy environment. Currently, Roche and Genentech maintain a significant U.S. presence with 13 manufacturing sites, 15 R&D facilities, and 25,000 employees across 24 locations in eight states. The new facility in Holly Springs, an established biopharmaceutical hub near Raleigh, reinforces their commitment to U.S. manufacturing and biotech innovation.

Roche (RHHBY) has launched the innovative Elecsys PRO-C3 test for assessing liver fibrosis severity in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The test, developed with Nordic Bioscience, delivers results in just 18 minutes on Roche's cobas analysers. When used with the ADAPT formula, which considers age, diabetes status, PRO-C3 levels, and platelet count, it can distinguish between different fibrosis severities.

MASLD affects approximately 30% of the population and is responsible for about one in every 25 deaths globally. The new test addresses a critical need as liver fibrosis often remains asymptomatic until advanced stages. Roche plans to launch software later this year to automate the ADAPT score calculation, further streamlining the diagnostic process.

Roche received a positive CHMP recommendation for updating the EU label of Phesgo, allowing its administration outside clinical settings. Phesgo, a subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer, could soon be administered at home by healthcare professionals.

Key highlights:

• Treatment costs could be reduced by up to 80% in Western Europe
• 85% of patients prefer subcutaneous over IV administration
• 91% of patients favor at-home treatment over in-clinic options
• Nearly half a million people are diagnosed with HER2-positive breast cancer worldwide annually

The recommendation is backed by clinical, real-world, and bioequivalence data showing feasibility and safety of at-home administration. Phesgo is currently approved in over 120 countries/regions as a subcutaneous alternative to intravenous treatment for both early-stage and metastatic HER2-positive breast cancer.

Roche has achieved a significant milestone as the FDA grants Breakthrough Device Designation for its VENTANA TROP2 RxDx Device, marking the first AI-driven companion diagnostic for non-small cell lung cancer (NSCLC).

The innovative device combines immunohistochemistry assay with digital pathology algorithms to analyze NSCLC tissue samples and compute quantitative TROP2 scores. It integrates AstraZeneca's Quantitative Continuous Scoring platform, enabling unprecedented diagnostic precision compared to traditional manual methods.

This breakthrough could accelerate the availability of TROP2 CDx AI-driven system, helping identify NSCLC patients who may benefit from treatment with DATROWAY, a TROP2-directed antibody drug conjugate jointly developed by AstraZeneca and Daiichi Sankyo.

The system includes:

• TROP2 algorithm
• navify Digital Pathology Image Management System
• Roche Digital Pathology scanners
• VENTANA TROP2 RxDx Assay with OptiView DAB Detection Kit

Roche (RHHBY) has published phase III CENTERSTONE trial results for Xofluza (baloxavir marboxil) in the New England Journal of Medicine, demonstrating significant reduction in influenza virus transmission. The trial met its primary endpoint, showing a 32% reduction in the odds of virus transmission from infected individuals to untreated household members with a single oral dose.

While the key secondary endpoint of reducing symptomatic transmission showed clinically meaningful reduction, it did not reach statistical significance. The drug demonstrated a favorable safety profile with no new safety concerns identified.

The findings have been submitted to both the FDA and EMA for review. This breakthrough is particularly significant as approximately one-third of all influenza transmission occurs within households, with seasonal influenza affecting an estimated one billion people worldwide annually, causing millions of hospitalizations and up to 650,000 deaths globally.