Roche Hldg Stock Price, News & Analysis

Genentech announced FDA acceptance of supplemental Biologics License Application (sBLA) for Gazyva to treat lupus nephritis. The application is based on positive Phase III REGENCY study results, where Gazyva plus standard therapy showed superior complete renal response compared to standard therapy alone.

Gazyva is the first anti-CD20 monoclonal antibody in a randomized Phase III study demonstrating complete renal response benefit. The study results, presented at World Congress of Nephrology and published in New England Journal of Medicine in February 2025, showed nearly 50% of patients on Gazyva plus standard therapy achieved complete renal response.

The FDA decision is expected by October 2025. Lupus nephritis affects 1.7 million people globally, with up to one-third of patients on current treatments progressing to end-stage kidney disease within 10 years. Gazyva received FDA Breakthrough Therapy Designation in 2019 based on Phase II NOBILITY study data.

Genentech, a Roche Group member (RHHBY), has received FDA approval for TNKase® (tenecteplase) to treat acute ischemic stroke (AIS) in adults, marking the first stroke medicine approval in nearly 30 years. TNKase is administered as a single five-second intravenous bolus, offering faster and simpler administration compared to the current standard-of-care Activase® (alteplase).

This approval makes Genentech the developer of the only two FDA-approved medicines for AIS treatment. The company plans to introduce a new 25 mg vial configuration in the coming months. The approval is supported by the AcT trial, a multi-center non-inferiority study conducted across 22 Canadian stroke centers, demonstrating TNKase's comparable safety and efficacy to Activase.

Stroke remains the fifth leading cause of death and the primary cause of long-term disability in the United States, affecting over 795,000 people annually. TNKase is also FDA-approved for treating acute ST-elevation myocardial infarction (STEMI) in adults.

Roche (RHHBY) announced new positive data from Stage 2 and 3 of the NIH-sponsored phase III OUtMATCH study for Xolair in food allergy treatment. The study demonstrated Xolair's superiority over oral immunotherapy (OIT):

Key findings from Stage 2 showed:

• 36% of Xolair patients tolerated 2,000mg of peanut protein plus two other allergens vs 19% in OIT group
• Significantly fewer adverse events with Xolair (0% serious AEs vs 30.5% for OIT)
• Lower treatment discontinuation (0% vs 22%) and reduced epinephrine use (6.9% vs 37.3%)

Stage 3 preliminary results revealed 82% of treatment plans included dietary consumption of allergenic foods, with higher success rates for milk, egg, and wheat (61-70%) compared to peanuts and tree nuts (38-56%). Xolair received FDA approval on February 16, 2024, as the first medicine to reduce allergic reactions in patients aged 1+ with IgE-mediated food allergies.

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.