Welcome to our dedicated page for RO news (Ticker: RO), a resource for investors and traders seeking the latest updates and insights on RO stock.
Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect RO's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.
Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of RO's position in the market.
Genentech, part of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced the discontinuation of dosing in the Phase III GENERATION HD1 study of tominersen for Huntington’s disease based on data reviewed by an Independent Data Monitoring Committee. While no new safety signals were identified, the study’s potential benefit/risk profile led to this decision. The open-label extension study (GEN-EXTEND) will also pause dosing for further analysis. Genentech aims to continue following participants for safety and outcomes, sharing insights within the HD community once full data is analyzed.
Genentech, part of Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the Phase III IMpower010 study of Tecentriq® (atezolizumab) met its primary endpoint of disease-free survival (DFS) in non-small cell lung cancer (NSCLC) patients at interim analysis. Significant DFS improvement was observed, especially in PD-L1-positive patients. Follow-up analyses will assess overall survival data. Tecentriq's safety profile remained consistent. Data will be presented at medical meetings and submitted to regulatory authorities for further evaluation.
Genentech, part of Roche Group (SIX: RO, ROG; OTCQX: RHHBY), released promising 2-year results from the SUNFISH study on Evrysdi™ (risdiplam) for Type 2 and non-ambulant Type 3 spinal muscular atrophy (SMA) in patients aged 2-25. Improvements in motor function achieved at 12 months were maintained or enhanced at 24 months across primary and secondary endpoints. The study, presented at the 2021 MDA Conference, showed no new safety signals. The findings reinforce Evrysdi's potential long-term benefits and favorable risk profile for SMA patients.
Genentech announced that the global Phase III REMDACTA study of Actemra (tocilizumab) plus Veklury (remdesivir) for treating severe COVID-19 pneumonia did not meet its primary endpoint of improved hospital discharge time. No new safety signals were reported for Actemra. The study, conducted with Gilead Sciences, failed to meet key secondary endpoints as well. Previous studies COVACTA did not meet its primary endpoint, while EMPACTA did. Genentech remains committed to evaluating the overall data for potential application of Actemra in COVID-19 treatments.
Genentech has announced the voluntary withdrawal of Tecentriq® (atezolizumab) from the U.S. market for prior-platinum treated metastatic urothelial carcinoma (mUC), following FDA consultation. This decision follows the failure of the IMvigor211 study to meet its primary overall survival endpoint. Genentech emphasizes that other approved indications for Tecentriq remain unaffected. The withdrawal reflects the evolving treatment landscape and aims to uphold the integrity of the FDA's Accelerated Approval Program.
Genentech announced FDA approval for Actemra® (tocilizumab) subcutaneous injection to slow pulmonary function decline in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD). This marks the first biologic therapy approved for this condition, impacting approximately 75,000 patients in the U.S. Key findings from the focuSSced Phase III trial indicated that Actemra reduced lung function decline compared to placebo, although the primary endpoint related to skin fibrosis was not met.
Common side effects included infections, aligning with Actemra's known safety profile.
Genentech, part of the Roche Group, announced publication of Evrysdi™ (risdiplam) data from the pivotal FIREFISH study. The study showed that 90% of infants with symptomatic Type 1 spinal muscular atrophy (SMA) survived without permanent ventilation after 12 months of treatment. Additionally, 33% of infants could sit independently for at least 5 seconds. The data highlights the drug's effectiveness in increasing survival of motor neuron (SMN) protein levels. Evrysdi, FDA-approved in August 2020, has promising implications for treating SMA in infants.
Genentech has announced positive results from four Phase III studies on its investigational bispecific antibody, faricimab, targeting diabetic macular edema (DME) and wet age-related macular degeneration (nAMD). Faricimab demonstrated non-inferior vision gains compared to aflibercept, with patients able to extend treatment intervals up to four months. Approximately 52.8% of DME patients and 45.7% of nAMD patients achieved four-month dosing in the first year. The studies showed no unexpected safety signals, indicating faricimab may improve treatment adherence and outcomes.
Genentech announced positive topline results from two Phase III studies, TENAYA and LUCERNE, for its bispecific antibody faricimab in treating neovascular age-related macular degeneration (nAMD). Both studies met their primary endpoint, demonstrating that faricimab injections at intervals up to 16 weeks achieved comparable visual acuity to aflibercept given every 8 weeks. Approximately 45% of participants receiving faricimab were treated every 16 weeks, marking a significant milestone in treatment durability. Faricimab was generally well tolerated with no new safety concerns.
Genentech, part of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the FDA has accepted its supplemental New Drug Application (sNDA) for Esbriet® (pirfenidone) to treat unclassifiable interstitial lung disease (UILD) and granted Priority Review. A decision is expected by May 2021. This sNDA is based on a Phase II trial, the first randomized controlled study for UILD, indicating Esbriet may benefit patients. The treatment has previously received Orphan Drug and Breakthrough Therapy Designations from the FDA.
