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.
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Genentech's Phase III SUNMO study demonstrated significant success in treating relapsed/refractory large B-cell lymphoma using a combination of Lunsumio and Polivy. The treatment showed a median progression-free survival of 11.5 months, three times longer than the standard R-GemOx therapy, and reduced disease progression risk by 59%. The combination therapy achieved a 70.3% objective response rate and doubled complete response rate to 51.4% compared to R-GemOx. Notably, 72.6% of complete responders maintained remission after one year. The treatment showed a favorable safety profile suitable for outpatient use, with low incidence of cytokine release syndrome and no neurotoxicity syndrome events reported. This chemotherapy-free combination represents a potential breakthrough as the first bispecific antibody and antibody-drug conjugate treatment for LBCL, with results to be submitted to global health authorities including the FDA.
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Genentech and AbbVie announced that their Phase III VERONA study investigating Venclexta (venetoclax) plus azacitidine for previously untreated higher-risk myelodysplastic syndromes (MDS) failed to meet its primary endpoint of overall survival. The global study involved approximately 500 patients across 220 sites, comparing Venclexta plus azacitidine to placebo plus azacitidine. While the safety profile aligned with known risks and showed no unexpected signals, the trial's failure represents a setback in the treatment development for higher-risk MDS patients. The companies plan to present complete data at an upcoming medical meeting in 2025, and the results do not affect Venclexta's currently approved indications or ongoing studies.
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Genentech, a Roche Group company, has announced plans to advance prasinezumab, a first-in-class anti-alpha-synuclein antibody, into Phase III development for early-stage Parkinson's disease. The decision follows encouraging results from the Phase IIb PADOVA study and open-label extensions of both PADOVA and PASADENA trials. While the drug missed statistical significance in its primary endpoint of confirmed motor progression, it demonstrated potential clinical benefits when combined with symptomatic treatments. The studies provided the first biomarker evidence of prasinezumab affecting underlying disease biology, with positive trends in reduced motor progression at 104 weeks that appeared sustained over longer periods. Currently, over 750 people with early-stage Parkinson's are participating in ongoing long-term safety and efficacy studies.
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Roche announced plans to advance prasinezumab, a potential first-in-class anti-alpha-synuclein antibody, into Phase III development for early-stage Parkinson's disease. The decision follows encouraging results from the Phase IIb PADOVA study and open-label extensions of PADOVA and PASADENA studies. While the primary endpoint of time to confirmed motor progression missed statistical significance, the drug showed positive trends in reducing motor progression at 104 weeks, with effects appearing sustained over longer periods. The studies provided first biomarker evidence of prasinezumab impacting underlying disease biology. The development aims to address the needs of over 10 million Parkinson's disease patients globally, with prasinezumab potentially becoming the first disease-modifying treatment for the condition.
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Roche has announced immediate dosing restrictions for Elevidys gene therapy in non-ambulatory Duchenne muscular dystrophy (DMD) patients following two fatal cases of acute liver failure. The company has halted commercial treatment and paused clinical trials for non-ambulatory patients, while treatment continues for ambulatory patients where benefit-risk remains positive. The fatal cases occurred among approximately 140 non-ambulatory patients treated globally. Multiple clinical trials, including ENVISION, ENVOL, and others, are affected by these restrictions. Elevidys is currently approved in eight territories outside the U.S., with Roche and Sarepta Therapeutics collaborating on commercialization and clinical studies. DMD affects 1 in 5,000 boys worldwide, causing progressive muscle weakness and eventual loss of mobility.
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Roche (RHHBY) has received European Commission approval for a new tablet formulation of Evrysdi (risdiplam), marking a significant advancement in Spinal Muscular Atrophy (SMA) treatment. The 5mg tablet, which can be swallowed whole or dispersed in water, offers room-temperature stability and doesn't require refrigeration. This new formulation maintains the same efficacy and safety as the original oral solution, as demonstrated in bioequivalence studies. Evrysdi, the only non-invasive disease-modifying SMA treatment, has treated over 18,000 patients globally. The tablet is approved for patients aged two years or older, weighing 20kg or more, who can swallow without a feeding tube. The original oral solution will remain available for patients requiring different doses or preferring that format.
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Roche announced positive Phase III IMforte study results for Tecentriq combined with lurbinectedin as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). The combination showed remarkable efficacy, reducing disease progression/death risk by 46% and death risk by 27% compared to Tecentriq alone. The median overall survival improved to 13.2 months versus 10.6 months with Tecentriq monotherapy, while progression-free survival increased to 5.4 months versus 2.1 months. The study marks the first Phase III trial in ES-SCLC first-line maintenance demonstrating significant improvements in both progression-free and overall survival. The treatment showed consistent safety profiles with no new safety signals, offering hope for ES-SCLC patients, where only 20% survive beyond two years.
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Genentech (RHHBY) announced positive Phase III IMforte study results for Tecentriq combined with lurbinectedin as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). The combination therapy demonstrated a 46% reduction in disease progression/death risk and 27% reduction in death risk compared to Tecentriq alone. The study showed median overall survival of 13.2 months for the combination versus 10.6 months for Tecentriq alone, and progression-free survival of 5.4 months versus 2.1 months respectively. This marks the first Phase III study in ES-SCLC first-line maintenance to show significant improvements in both progression-free and overall survival. The results, presented at the 2025 ASCO Annual Meeting and published in The Lancet, could represent a practice-changing treatment option for this aggressive cancer type, where only 20% of patients survive beyond two years.
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Roche announced positive final results from the phase III INAVO120 study for Itovebi (inavolisib). The drug, combined with palbociclib and fulvestrant, demonstrated a 30% reduction in death risk for patients with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer. The median overall survival improved to 34.0 months with Itovebi versus 27.0 months in the control group. The treatment doubled progression-free survival to 17.2 months compared to 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. Itovebi is already approved in several countries including the US, Switzerland, and China, with pending European approval. The drug showed good tolerability with no new safety concerns.
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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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FAQ
What is the current stock price of Roche Hldg (RHHBY)?
The current stock price of Roche Hldg (RHHBY) is $54.25 as of January 16, 2026.
What is the market cap of Roche Hldg (RHHBY)?
The market cap of Roche Hldg (RHHBY) is approximately 269.4B.
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