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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.
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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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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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FAQ
What is the current stock price of Roche Hldg (RHHBY)?
The current stock price of Roche Hldg (RHHBY) is $40.16 as of June 16, 2025.
What is the market cap of Roche Hldg (RHHBY)?
The market cap of Roche Hldg (RHHBY) is approximately 279.1B.
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