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Roche Hldg Stock Price, News & Analysis

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Welcome to our dedicated page for Roche Hldg news (Ticker: RHHBY), a resource for investors and traders seeking the latest updates and insights on Roche Hldg stock.

Roche Holding AG (RHHBY) is a global pioneer in biotechnology and diagnostics, driving innovations in personalized healthcare through groundbreaking pharmaceuticals and advanced diagnostic solutions. This dedicated news hub provides investors and industry professionals with timely updates on corporate developments, research breakthroughs, and strategic initiatives shaping modern medicine.

Access authoritative information on Roche's financial performance, regulatory milestones, and therapeutic advancements. Our curated news collection includes:

• Earnings reports and investor communications
• FDA/EMA regulatory updates
• Clinical trial results and R&D partnerships
• Diagnostic technology launches
• Strategic acquisitions and collaborations

Bookmark this page for comprehensive tracking of Roche's progress in oncology, immunology, and molecular diagnostics. Stay informed about developments impacting one of healthcare's most influential innovators through verified updates from primary sources.

News

New Data Show Genentech’s Itovebi Significantly Extended Survival in a Certain Type of HR-positive Advanced Breast Cancer

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Genentech (RHHBY) announced positive final results from the Phase III INAVO120 study of Itovebi (inavolisib) for PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer. The Itovebi-based regimen, combined with palbociclib and fulvestrant, significantly reduced death risk by over 30% compared to palbociclib and fulvestrant alone. The median overall survival improved to 34.0 months versus 27.0 months in the control arm. The treatment doubled progression-free survival to 17.2 months from 7.3 months and delayed chemotherapy by approximately two years. The PIK3CA mutation affects about 40% of HR-positive advanced breast cancers and typically indicates poor prognosis. The study results are being presented at the 2025 ASCO Annual Meeting and published in the New England Journal of Medicine.
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Roche’s fenebrutinib maintains near-complete suppression of disease activity and disability progression for up to two years in people with relapsing multiple sclerosis

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Roche announced promising 96-week data for fenebrutinib in treating relapsing multiple sclerosis (RMS). The Phase II FENopta open-label extension study showed patients maintained no disability progression and low disease activity for up to two years. Key findings include an annualized relapse rate of 0.06 (equivalent to one relapse every 17 years), zero new T1 gadolinium-enhancing lesions at 96 weeks, and a reduction in T2 lesions from 6.72 to 0.34 in the placebo-to-treatment group. Of 99 patients who entered the study, 93 remained after 96 weeks. The safety profile remained consistent with previous data, with common adverse events including COVID-19 (10%) and urinary tract infection (10%). Three Phase III trials are ongoing, with initial results expected by end of 2025.
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CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer

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Roche (RHHBY) received a positive CHMP recommendation for Itovebi (inavolisib) in combination with palbociclib and fulvestrant for treating PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer. The recommendation is based on Phase III INAVO120 trial results showing the Itovebi regimen reduced disease progression risk by 57% compared to standard treatment (15.0 vs 7.3 months PFS). The treatment demonstrated significant overall survival benefits in final analysis. PIK3CA mutations occur in ~40% of hormone receptor-positive breast cancers, making the disease more aggressive. The Itovebi combination is already approved in several countries including the US, Switzerland, and China. Roche is conducting three additional Phase III studies exploring Itovebi in various breast cancer combinations.
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Roche announces new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technology

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Roche (RHHBY) has announced a strategic collaboration with Broad Clinical Labs to develop and implement applications using Roche's next-generation Sequencing By Expansion (SBX) technology. The initial focus will be on trio-based whole genome sequencing for critically ill newborns and their biological parents in neonatal intensive care units (NICUs), aiming to enable faster diagnosis of genetic disorders.

The collaboration will explore integrating SBX technology into routine clinical practice and research applications. The technology offers ultra-fast turnaround times, exceptional scalability, and cost efficiency. Additionally, the partnership will investigate SBX capabilities for RNA sequencing, including bulk and single-cell approaches, to gain novel molecular insights for disease understanding and therapeutic target identification.

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New two-year follow-up of Roche’s Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma patients

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Roche (RHHBY) announced promising two-year follow-up data from the phase III STARGLO study for Columvi® in combination with chemotherapy for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The data showed a 40% improvement in overall survival compared to standard treatment. Key findings include:

- 89% of complete responders were alive one year post-treatment - 82% maintained remission after one year - 58.5% complete remission rate (vs 25.3% in control group) - 59% reduction in disease progression/death risk

The Columvi combination is now approved in over 30 countries for R/R DLBCL patients who aren't candidates for autologous stem cell transplant. The treatment's safety profile remained consistent with previous analyses, with cytokine release syndrome being a common but generally low-grade adverse event.

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New Two-year Follow-up of Genentech’s Columvi Extends Overall Survival in Relapsed or Refractory Diffuse Large B-cell Lymphoma Patients

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Genentech announced promising two-year follow-up data from the Phase III STARGLO study for Columvi in treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The data showed a 40% improvement in overall survival for patients treated with Columvi combination therapy compared to standard treatment. After median follow-up of 24.7 months, patients receiving Columvi plus GemOx showed significant benefits: 89% of complete responders were alive and 82% maintained remission one year post-treatment. The study demonstrated a 59% reduction in disease progression/death risk and more than double the complete remission rate (58.5% vs 25.3%). Columvi combination is now approved in over 30 countries and included in NCCN Guidelines as a category 1 preferred recommendation for second-line DLBCL treatment.

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FDA approves Roche’s Susvimo for diabetic retinopathy

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Roche (RHHBY) has received FDA approval for Susvimo to treat diabetic retinopathy (DR), marking its third approved indication. Susvimo, utilizing the Port Delivery Platform, is the first continuous delivery treatment requiring only one refill every nine months for DR patients who previously responded to anti-VEGF injections. The approval is based on the phase III Pavilion study, where patients showed superior improvements on the Diabetic Retinopathy Severity Scale compared to monthly observation with as-needed anti-VEGF injections. The treatment involves a refillable eye implant surgically inserted during an outpatient procedure. DR affects nearly 10 million people in the US and over 100 million globally. Notably, no participants required supplemental treatment at one year, and the safety profile remained consistent with previous findings.
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FDA Approves Genentech’s Susvimo for Diabetic Retinopathy

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The FDA has approved Genentech's Susvimo (ranibizumab injection) for treating diabetic retinopathy (DR), marking its third FDA-approved indication. This innovative treatment, utilizing the Port Delivery Platform, requires only one refill every nine months, offering an alternative to frequent eye injections. The approval follows successful Phase III Pavilion study results, where patients showed superior improvements on the Diabetic Retinopathy Severity Scale compared to monthly observation with as-needed anti-VEGF injections. Susvimo is administered through a refillable eye implant surgically inserted during an outpatient procedure. The treatment is specifically approved for DR patients who have previously responded to at least two anti-VEGF injections. DR affects nearly 10 million people in the US and over 100 million globally.
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Roche provides update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

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A FDA Advisory Committee discussed Roche's (RHHBY) supplemental Biologics License Application for Columvi in combination with GemOx for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The phase III STARGLO study demonstrated that the Columvi combination reduced death risk by 41% compared to standard treatment, with median overall survival of 25.5 months vs 12.9 months. The treatment also showed a 63% reduction in disease progression risk. While Committee members requested additional data regarding US patient applicability, the treatment is already approved in 30+ countries and included in NCCN guidelines as a category 1 preferred regimen. The FDA's final decision is expected by July 20, 2025.
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Roche receives FDA approval for the VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-squamous non-small cell lung cancer patients eligible for treatment with Emrelis

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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.

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FAQ

What is the current stock price of Roche Hldg (RHHBY)?

The current stock price of Roche Hldg (RHHBY) is $42.74 as of September 4, 2025.

What is the market cap of Roche Hldg (RHHBY)?

The market cap of Roche Hldg (RHHBY) is approximately 259.1B.
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RHHBY Stock Data

259.07B
731.00M
0.83%
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