[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III GRADUATE programme evaluating gantenerumab in early Alzheimer ’s disease
Phase III GRADUATE studies did not meet their primary endpoints of slowing clinical decline in people with early Alzheimer ’sThe level of beta-amyloid removal bygantenerumab was lower than expectedTopline data will be presented at the Clinical Trials on Alzheimer ’s Disease (CTAD) ConferenceRoche is committed to the Alzheimer ’s community and will continue to develop novel diagnostics and potential treatments for Alzheimer ’sBasel, 14 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) du...
Source: Roche Investor Update - November 14, 2022 Category: Pharmaceuticals Source Type: news
STRONG-HF study results demonstrate clear benefits for acute heart failure patients
STRONG-HF study primary outcomes showed significant reduction of all cause death or acute heart failure readmissions, at day 180, when the study strategy was implementedRapid, simultaneous up-titration of therapies, and close follow-up, led to increased patient quality of life.The RocheElecsys® NT-proBNP biomarker is an integral part of the treatment strategy, comprising rapid up-titration and close follow up after an acute heart failure admissionBasel, 9 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced publication of the Safety, Tolerability and Efficacy of Rapid Optimization of Heart Failure (STRONG-HF...
Source: Roche Investor Update - November 9, 2022 Category: Pharmaceuticals Source Type: news
Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs
Interim data from phase III HAVEN 7 study reinforceHemlibra ’s efficacy and safety in infants with severehaemophilia A without factor VIII inhibitors1New and updated data support use ofPolivy in diffuse large B-cell lymphoma, including its potential as a treatment option for previously untreated patients2New and updated data for innovative CD20xCD3 T-cell engaging bispecific antibodiesLunsumio andglofitamab further enhance their potential as effective, off-the-shelf, fixed-duration treatment options for people with lymphoma3,4,5,6,7First phase III data forcrovalimab show the co-primary efficacy endpoints were met, with s...
Source: Roche Investor Update - November 3, 2022 Category: Pharmaceuticals Source Type: news
Save the Date: Roche Virtual Event – Update following ASH 2022 Wednesday 14th December 2022
We are pleased to invite investors and analysts to participate in our virtual event onWednesday, 14December 2022, highlighting Roche data presented at the American Society of Hematology 2022 Meeting and Exposition, from 10th to 13th December. 16:00 – 17:30 CET / 15:00 - 16:30 GMT10:00 – 11:30 am EST / 7:00 – 8:30 am PST An invitation with the detailed programme and registration link will follow soon. Best regards, Bruno EschliHead of Investor Relations Loren KalmHead of Investor Relations, North AmericaRoche Investor Relations Dr. BrunoEschliPhone: +41 61 68-75284e-mail:bruno.eschli@roche.com Dr. Sabin...
Source: Roche Investor Update - November 1, 2022 Category: Pharmaceuticals Source Type: news
Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO)
Vabysmo achieved its primary endpoint of non-inferiority toaflibercept in RVO in the BALATON and COMINO clinical trialsVabysmo was generally well tolerated, with a safety profile consistent with previous trialsVabysmo is the first and only treatment that targets and inhibits two disease pathways involving Ang-2 and VEGF-A, linked to a number of vision-threatening retinal conditionsDetailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the worldBasel, 27 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two global phase I...
Source: Roche Investor Update - October 27, 2022 Category: Pharmaceuticals Source Type: news
Early treatment with Roche's OCREVUS leads to reduced disease progression and healthcare costs; nine-year safety data reinforce favourable benefit-risk profile
77% of early-stage relapsing-remitting multiple sclerosis (RRMS) patients who had not received prior treatment achieved no evidence of disease activity (NEDA) at two yearsInitiation of OCREVUS as first-line treatment reduces relapses,hospitalisations and costs compared with using OCREVUS in second-line settingNine-year long-term safety data for OCREVUS further reinforcefavourable benefit-risk profile; more than 250,000 people have been treated globallyPregnancy outcomes reported for more than 2,000 women with multiple sclerosis (MS) treated with OCREVUS do not suggest an increased risk of adverse pregnancy and infant outco...
Source: Roche Investor Update - October 26, 2022 Category: Pharmaceuticals Source Type: news
Roche receives FDA clearance for COVID-19 PCR test for use on cobas 6800/8800 Systems
The cobas SARS-CoV-2 Qualitative test is one of the first COVID-19 PCR tests performed on an automated, high throughput platform to receive FDA 510(k) clearance.This FDA clearance will ensure that the healthcare community has access to timely, reliable and accurate COVID-19 PCR testing beyond the EUA period.Based on continuous analysis performed since the onset of the pandemic, all Roche molecular tests, including the cobas SARS-CoV-2 Qualitative test, detect all SARS-CoV-2 variants. Basel, 24 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted...
Source: Roche Investor Update - October 24, 2022 Category: Pharmaceuticals Source Type: news
Roche to present new OCREVUS (ocrelizumab) data in multiple sclerosis and continued research into neuromyelitis optica spectrum disorder at ECTRIMS 2022
OCREVUS data will show significant benefit on slowing disease activity and progression in patients with treatment-naive early-stage relapsing-remitting multiple sclerosis (RRMS)Largest pregnancy safety data across anti-CD20 medicines for OCREVUS in multiple sclerosis (MS)Nine-year safety data for OCREVUS reinforces itsfavourable benefit-risk profileNew research demonstrates impact of misdiagnosis and delay of starting treatment in NMOSDBasel, 19 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new OCREVUS ® (ocrelizumab) data and continued research into neuromyelitis optica spectrum disorder (NMOSD) ...
Source: Roche Investor Update - October 19, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche records solid results for the first nine months of 2022
Group salesup 2%[1] at constant exchange rates (CER) and 1% in Swiss francs; as expected, significantly lower COVID-19-related sales in both divisions in the third quarterSales in the Pharmaceuticals Divisionat the previous year ’s level with significantly lower sales of COVID-19-related products (Ronapreve and Actemra/RoActemra) and losses to biosimilars, offset by strong growth of newer medicinesSales in the Diagnostics Divisionrise 6%; base business remains strong; as expected, demand for COVID-19 tests sharply down in third quarterHighlights in the third quarter:EU approval forVabysmo (severe eye diseases)US approval...
Source: Roche Investor Update - October 18, 2022 Category: Pharmaceuticals Source Type: news
Roche to introduce its next-generation portfolio of SARS-CoV-2 rapid antigen tests ( “2.0”) under CE Mark for self-test and professional use
Broad and trusted portfolio of COVID-19 rapid tests feature innovative updatesand enhanced performance, building on insights gained throughout the pandemicAll tests now work seamlessly withnavify® Pass, Roche’s digital solution that allows individuals and healthcare professionals to immediately store, display, and share COVID-19 vaccination status and test results through a unique data matrixRoche maintains the capacity to provide tens of millions tests each month to meet sustained high worldwide demand from individuals and healthcare professionalsBasel, 12 October 2022- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announce...
Source: Roche Investor Update - October 12, 2022 Category: Pharmaceuticals Source Type: news
Positive new data for Roche ’s Evrysdi in largest trial ever undertaken in patients with previously-treated spinal muscular atrophy (SMA)
New two-year Evrysdi data show improvement or maintenance of motor function in people with SMA, a progressive neuromuscular disease that can be fatalThe JEWELFISH study enrolled the broadest and most diverse patient population ever studied in an SMA trialLonger-term safety data consistent with that previously seen in earlier trials and low study drop-out rateEvrysdi has proven efficacy in babies, children and adults, with more than 7,000 patients treated to date worldwideBasel, 12 October 2022- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new two-year data from the JEWELFISH study evaluating Evrysdi ® (risdiplam) in...
Source: Roche Investor Update - October 12, 2022 Category: Pharmaceuticals Source Type: news
Reminder: Invitation to Roche ’s 3rd Quarter Sales 2022 Webinar
Roche will publish its Sales Results for the 3rd Quarter of 2022 prior to the opening of the Swiss Stock Exchange onTuesday,18 October 2022. 07:00 CEST / 06:00 BST / 01:00 AM EDT / 10:00 PM PDT (evening before) Release will be e-mailed and posted on the Roche IR website>click herePresentation slides will be posted on the Roche IR website>click here 14:00 – 15:30 CEST / 13:00 – 14:30 BST08:00 – 09:30 AM EDT / 05:00 - 06:30 AM PDT The webinar will start with presentations by senior management,followed by a Q&A session. Presenters:Severin Schwan, CEO Roche GroupBill Anderson, CEO Roche Pharmace...
Source: Roche Investor Update - October 11, 2022 Category: Pharmaceuticals Source Type: news
Roche launches PRAME (EPR20330) Antibody to identify PRAME protein expression in patients that may have melanoma
The PRAME (EPR20330) Antibody evaluates PRAME protein expression from patients with suspected melanoma.Understanding if the PRAME protein is expressed helps enable more informed clinical decisions and may improve patient outcomes.The PRAME (EPR20330) Antibody is the latest addition to Roche ’s robust dermatology portfolio with more than 50 dermatology biomarkers designed to meet a broad range of diagnostic needs.Basel, 11 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of Anti-PRAME (EPR 20330) Rabbit Monoclonal Primary Antibody to identify PRAME protein expression in tissue samples from pati...
Source: Roche Investor Update - October 11, 2022 Category: Pharmaceuticals Source Type: news
Roche to present new data from its expanding neuromuscular disease portfolio at World Muscle Society 2022
New positive data fromEvrysdi, a treatment for spinal muscular atrophy (SMA), a progressive neuromuscular disease that can be fatalData from the gene therapyprogramme forDuchenne muscular dystrophy (DMD), a progressive disease that leads to premature death, reinforce confidence in the most advanced Phase 3 study currently underwayStudy designs of two new trials ingeneralised myasthenia gravis (gMG), a rare chronic autoimmune disease, andfacioscapulohumeral muscular dystrophy (FSHD), a genetic muscle disorderBasel, 05 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its industry-leading n...
Source: Roche Investor Update - October 5, 2022 Category: Pharmaceuticals Source Type: news
[Ad hoc announcement pursuant to Art. 53 LR] Roche: Change in the Corporate Executive Committee in January 2023
Basel, 3 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Matt Sause (45), currently Head of Roche Diagnostics ’ North America Region, will become CEO Roche Diagnostics and a member of the Corporate Executive Committee effective 1 January 2023.Thomas Schinecker, the incumbent CEO of the Diagnostics Division and new Roche CEO as of 15 March 2023: “Matt Sause’s career at Roche has spanned twenty years in multiple countries across Asia, Latin America, Europe and North America in both the Diagnostics and Pharma divisions. His combination of scientific knowledge with commercial experience makes him a...
Source: Roche Investor Update - October 3, 2022 Category: Pharmaceuticals Source Type: news
