Roche Hldg Stock Price, News & Analysis

Roche has received a CHMP recommendation for EU approval of Columvi (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients ineligible for autologous stem cell transplant.

The recommendation is based on the phase III STARGLO study results, which demonstrated a 41% reduction in death risk compared to rituximab and GemOx. If approved, this combination will become the first bispecific antibody regimen available for DLBCL patients post-relapse.

DLBCL affects approximately 38,000 Europeans annually, with 40% of patients relapsing after initial treatment. The Columvi combination offers an off-the-shelf, fixed-duration treatment option that can be initiated immediately after cancer returns, addressing a significant unmet need in DLBCL treatment.

Roche has unveiled its breakthrough sequencing by expansion (SBX) technology, establishing a new category of next-generation sequencing (NGS). The innovative technology combines sophisticated biochemistry with a high-throughput sensor module to determine DNA sequences using expanded synthetic molecules called Xpandomers.

The SBX technology creates Xpandomers that are fifty times longer than the original molecule and provide clear signals with minimal background noise. This enables highly accurate single-molecule nanopore sequencing using a CMOS-based sensor module with parallel processing capabilities. The technology can reduce genome sequencing time from days to hours, offering unprecedented speed, efficiency, and flexibility.

The technology aims to enhance genomic research and decode complex diseases like cancer, immune disorders, and neurodegenerative conditions. Its ultra-rapid, high-throughput, flexible, and scalable nature makes it suitable for various applications, with potential future adoption in clinical lab settings.

Roche (RHHBY) has received FDA approval for a new tablet formulation of Evrysdi (risdiplam), the only non-invasive disease-modifying treatment for Spinal Muscular Atrophy (SMA). The 5 mg tablet, approved for patients two years and older weighing over 20 kg, can be swallowed whole or dispersed in water and stored at room temperature.

A bioequivalence study demonstrated that the tablet provides comparable exposure to risdiplam as the original oral solution, ensuring the same efficacy and safety profile. The oral solution will remain available for patients on other doses or those who prefer it. The new tablet formulation is expected to be available in the coming weeks.

Evrysdi is currently approved in over 100 countries, offering simplified dose administration that may provide greater freedom and independence for SMA patients in their daily activities such as working, traveling, and education.

Genentech, a Roche Group member, announced FDA approval for Evrysdi® (risdiplam) tablet, the first and only tablet treatment for spinal muscular atrophy (SMA). The new 5 mg tablet, which can be swallowed whole or dispersed in water, provides the same efficacy and safety as the current oral solution and can be stored at room temperature.

The approval was based on a bioequivalence study confirming comparable exposure to risdiplam between the tablet and oral solution formulations. The tablet is suitable for patients 2 years or older weighing more than 44 lbs (20 kgs). Evrysdi, approved in over 100 countries, is the only non-invasive disease-modifying SMA treatment available.

The oral solution will remain available for patients on other doses or those who prefer it. The new tablet formulation aims to provide greater independence and convenience for SMA patients through simplified dose administration.

Roche announced significant results from its phase III REGENCY trial of Gazyva/Gazyvaro in treating lupus nephritis, published in the New England Journal of Medicine. The study showed that 46.4% of patients receiving Gazyva/Gazyvaro plus standard therapy achieved complete renal response (CRR) at 76 weeks, compared to 33.1% with standard therapy alone.

The treatment demonstrated consistent benefits across patient subgroups and showed improvements in complement levels and reductions in disease activity markers. Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a phase III study to show CRR benefit. The safety profile aligned with previous observations in hematology-oncology indications.

Key secondary endpoints revealed higher proteinuric response rates and better CRR with successful corticosteroid reduction in the Gazyva/Gazyvaro group. The drug previously received FDA Breakthrough Therapy Designation in 2019 based on phase II NOBILITY study data.

Genentech announced significant results from its Phase III REGENCY trial of Gazyva (obinutuzumab) for active lupus nephritis, published in the New England Journal of Medicine. The study showed that 46.4% of patients treated with Gazyva plus standard therapy achieved complete renal response (CRR) at 76 weeks, compared to 33.1% with standard therapy alone.

The trial demonstrated consistent benefits across patient subgroups, with improvements in complement levels and reductions in disease activity markers. Key secondary endpoints revealed that patients receiving Gazyva were more likely to achieve CRR with successful corticosteroid reduction and showed improved proteinuric response versus standard therapy alone.

Gazyva is the only anti-CD20 monoclonal antibody to demonstrate CRR benefit in a Phase III lupus nephritis study. The drug's safety profile remained consistent with its known profile in hematology-oncology indications.

Genentech, a Roche Group member, announced FDA approval of Susvimo (ranibizumab injection) for treating diabetic macular edema (DME), which affects over 29 million adults worldwide. This marks Susvimo's second FDA-approved indication, following its 2021 approval for wet age-related macular degeneration.

The approval is based on the Phase III Pagoda study's one-year results, where Susvimo demonstrated non-inferior vision improvements compared to monthly ranibizumab injections (9.6 vs 9.4 eye chart letters). Notably, Susvimo requires only two treatments per year through its Port Delivery Platform, offering a significant advantage over current treatments that may need monthly injections.

The company is providing comprehensive access and reimbursement support services through Genentech Access Solutions for eligible patients.

Roche (RHHBY) has received FDA approval for Susvimo to treat diabetic macular edema (DME), marking its second indication after wet age-related macular degeneration. DME affects over 29 million adults worldwide and is a leading cause of vision loss in diabetic adults.

The treatment offers a groundbreaking continuous delivery system requiring only two treatments per year, compared to traditional monthly eye injections. The approval is based on the phase III Pagoda study results, where Susvimo demonstrated non-inferior vision improvements compared to monthly ranibizumab injections (9.6 vs 9.4 eye chart letters).

Susvimo's Port Delivery Platform provides continuous medication delivery, offering a more convenient alternative to current treatments that may require monthly injections. The product is now available to US retina specialists and their DME patients.

Roche has received FDA approval for an expanded use of its PATHWAY HER2 (4B5) test, making it the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU treatment. This advancement 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 promising results, showing a median progression-free survival of 13.2 months with ENHERTU compared to 8.1 months with standard chemotherapy. This test expansion builds upon Roche's 2022 approval for HER2-low status assessment, further strengthening their position in HER2 diagnostics and expanding treatment options for breast cancer patients.