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 Ltd/ADR (RHHBY) is linked to a stream of news that reflects the company’s activities in biotechnology, pharmaceuticals and diagnostics. Recent announcements from Roche and its U.S. affiliate Genentech highlight regulatory approvals, late‑stage clinical trial results, new diagnostic platforms and agreements related to access and manufacturing.
Investors and healthcare observers following RHHBY news will see updates on oncology and haematology programmes, such as the U.S. Food and Drug Administration’s accelerated approval of Lunsumio VELO, a subcutaneous CD20xCD3 bispecific antibody for relapsed or refractory follicular lymphoma after at least two prior lines of systemic therapy. News also covers Phase III data for the investigational oral SERD giredestrant in ER‑positive early‑stage breast cancer, as well as new data on Lunsumio combinations and long‑term outcomes in lymphomas presented at major scientific meetings.
On the diagnostics side, Roche has reported the U.S. launch of next‑generation cobas 6800/8800 systems and software upgrades, CE Mark approval for its cobas Mass Spec solution reagent pack for antibiotics drug monitoring, and CE Mark for the cobas BV/CV assay for bacterial vaginosis and candida vaginitis. These stories illustrate how the company is expanding its in‑vitro diagnostic menu and enhancing laboratory efficiency.
Additional news items include European Commission approval of Gazyva/Gazyvaro for lupus nephritis and Genentech’s agreement with the U.S. government addressing prescription drug costs and direct‑to‑patient programmes. For users of this page, the RHHBY news feed offers a central place to review such regulatory milestones, clinical trial readouts, product launches and policy‑related developments associated with Roche and the Roche Group.
Roche announced new data for its Elecsys Amyloid Plasma Panel at CTAD congress, demonstrating high accuracy in ruling out Alzheimer's disease. The blood-based test showed a 96.2% negative predictive value in a study of 492 patients across US and Europe, with 91.0% sensitivity and 69.8% specificity. The test combines pTau181 and ApoE4 measurements and received FDA Breakthrough Device Designation in July 2023. This development could potentially eliminate the need for invasive testing, offering a faster and more accessible diagnostic solution for Alzheimer's disease, which currently affects many undiagnosed patients who wait an average of 2.8 years after symptom onset for diagnosis.
Roche announced the publication of phase III INAVO120 trial results for Itovebi in the New England Journal of Medicine. The Itovebi-based regimen showed significant benefits in HR-positive, HER2-negative breast cancer patients with PIK3CA mutations, reducing disease progression or death risk by 57% compared to standard treatment. The median progression-free survival improved to 15.0 months versus 7.3 months with palbociclib and fulvestrant alone. The FDA recently approved this combination as first-line treatment. The PIK3CA mutation affects approximately 40% of HR-positive metastatic breast cancers and is associated with poor prognosis.
Genentech's Itovebi demonstrates significant results in Phase III INAVO120 study for HR-positive advanced breast cancer, published in the New England Journal of Medicine. The Itovebi-based regimen showed a 57% reduction in disease progression or death risk compared to standard treatment, extending progression-free survival from 7.3 to 15.0 months. The FDA recently approved Itovebi combined with palbociclib and fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative breast cancer. The mutation occurs in about 40% of HR-positive metastatic breast cancers and typically indicates poor prognosis. Early survival data shows positive trends, with continued follow-up planned.
Roche reported strong Group sales growth of 6% (CER) to CHF 45.0 billion in the first nine months of 2024, with a notable 9% increase in Q3. The Pharmaceuticals Division saw 7% growth to CHF 34.3 billion, driven by newer medicines like Vabysmo, Phesgo, and Ocrevus. The Diagnostics Division grew 5% to CHF 10.7 billion.
Key achievements include US approvals for Itovebi (breast cancer), Ocrevus Zunovo (multiple sclerosis), and Tecentriq Hybreza (cancer), plus EU approvals for Vabysmo (eye disease) and PiaSky (blood condition). Positive phase III data was reported for several medicines including Gazyva/Gazyvaro and Xofluza.
Roche announced positive one-year results from the ELEVATUM study, evaluating Vabysmo® (faricimab) for diabetic macular edema (DME) in underrepresented racial and ethnic groups. The study showed:
- Participants could read an additional 12.3 letters on average after one year of treatment
- Hispanic and Latino participants gained an average of 14.1 letters
- African American and Black participants gained an average of 11.3 letters
- A decrease of 206.3 microns in central subfield thickness (CST) from baseline
The study included 124 participants, with 45% self-identifying as Hispanic or Latino and 48% as Black or African American. Vabysmo was well-tolerated, with no new safety events identified. These results are consistent with previous phase III studies and demonstrate Vabysmo's effectiveness in treating DME in underrepresented populations.
Genentech announced positive one-year results from the ELEVATUM study, evaluating Vabysmo for treating diabetic macular edema (DME) in underrepresented racial and ethnic groups. The study showed:
- Participants could read an additional 12.3 letters on average after one year of treatment
- Hispanic and Latino participants gained an average of 14.1 letters
- African American and Black participants gained an average of 11.3 letters
- A decrease of 206.3 microns in central subfield thickness, indicating retinal drying
The study included 45% Hispanic or Latino and 48% Black or African American participants. Results were consistent with previous Phase III studies, and Vabysmo was well-tolerated with no new safety events identified. This first-of-its-kind study aims to address health disparities and improve clinical trial representation for populations disproportionately affected by DME.
Roche has received FDA approval for the VENTANA CLDN18 (43-14A) RxDx Assay, the first companion diagnostic to identify patients with gastric and gastroesophageal junction (GEJ) cancer eligible for targeted treatment with VYLOY. This immunohistochemistry (IHC) assay helps determine CLDN18 protein expression in tumors, enabling clinicians to identify patients who may benefit from Astellas' targeted therapy VYLOY (zolbetuximab).
The assay addresses an unmet medical need by helping predict the likelihood of response to targeted therapy in gastric and GEJ cancers. CLDN18.2 is an emerging biomarker in these cancers. This approval aligns with current guidelines recommending biomarker use to guide therapeutic decision-making in gastric/GEJ cancer.
Gastric cancer is the fifth most common cancer and fourth leading cause of cancer deaths worldwide. In the U.S., 62% of gastric/GEJ cancer cases are advanced at initial diagnosis, with a five-year overall survival rate of only 6%.
Roche presented positive two-year data from the RAINBOWFISH study at the 29th World Muscle Society Congress, evaluating Evrysdi® (risdiplam) in children with spinal muscular atrophy (SMA) treated pre-symptomatically before six weeks of age. The study found:
- Majority of children achieved key motor milestones
- All children could swallow and feed orally
- No children required permanent ventilation
- Cognitive skills were typical of children without SMA
Children with three or more SMN2 copies (n=18) achieved 100% standing and walking milestones. Those with two SMN2 copies (n=5) could all sit, and 60% could stand and walk independently after two years. The study reported no deaths or adverse events leading to withdrawal. Evrysdi is the only non-invasive SMA therapy approved in over 100 countries, with more than 16,000 people treated globally.
Genentech presented positive 2-year data from the ongoing RAINBOWFISH study at the 29th World Muscle Society Congress, evaluating Evrysdi® (risdiplam) in children with Spinal Muscular Atrophy (SMA) treated pre-symptomatically before 6 weeks of age. The study found that the majority of children achieved key motor milestones, were able to swallow and feed orally, and demonstrated typical cognitive skills, with none requiring permanent ventilation.
All children with three or more SMN2 copies achieved standing and walking milestones, while all children with two SMN2 copies could sit and most could stand and walk independently after 2 years of treatment. The study also assessed cognition as an exploratory endpoint, showing cognitive skills typical of children without SMA.
Evrysdi is the only non-invasive SMA therapy approved in over 100 countries, with more than 16,000 people treated globally. The treatment was well-tolerated, with no deaths or adverse events leading to withdrawal or treatment discontinuation.
Roche has received FDA approval for Itovebi™ (inavolisib), a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. The approval is based on the Phase III INAVO120 study results, which showed that the Itovebi-based regimen more than doubled progression-free survival compared to standard treatment in the first-line setting.
Itovebi, in combination with palbociclib and fulvestrant, is approved for adults with endocrine-resistant, PIK3CA-mutated breast cancer following recurrence on or after adjuvant endocrine therapy. The PIK3CA mutation is found in approximately 40% of HR-positive metastatic breast cancers.
The INAVO120 study demonstrated that the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone. Itovebi will be available in the US in the coming weeks, marking an important step in Roche's efforts to bring innovative medicines to more people with breast cancer.