Latest news with #OleksSH
Yahoo
4 days ago
- Business
- Yahoo
Roche's Multiple Sclerosis Drug Shows Low Disease Activity Over Two Years
Roche Holdings AG (OTC:RHHBY) on Friday announced new 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low disease activity levels for up to two years. The latest results for this investigational Bruton's tyrosine kinase (BTK) inhibitor from the Phase II FENopta open-label extension (OLE) study were presented at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. Ninety-nine patients entered the OLE and 93 remained in the OLE after 96 the OLE period, patients treated with fenebrutinib for up to 96 weeks had a low annualised relapse rate (ARR) of 0.06, and during this time there was no disability progression, as measured by the Expanded Disability Status Scale (EDSS). MRI scans showed that fenebrutinib treatment suppressed disease activity in the brain. At 96 weeks zero new T1 gadolinium-enhancing (T1-Gd+) lesions, which are markers of active inflammation, were detected. In the treatment group that switched from placebo to fenebrutinib in the OLE, the annualized rate of new or enlarging T2 lesions, which represent chronic disease burden, decreased from 6.72 at the end of the 12-week double-blind period to 0.34 by 96 weeks. The safety profile of fenebrutinib in the OLE was consistent with previously reported data, with no new safety concerns identified at 96 weeks. During the OLE, one patient experienced asymptomatic alanine aminotransferase elevation at OLE week 4, after 16 weeks on treatment, which resolved with treatment discontinuation. Three Phase 3 trials are ongoing, including the FENhance 1 and 2 trials in RMS and the FENtrepid trial in primary progressive multiple sclerosis (PPMS). The first data from these studies are expected at the end of 2025. In April, Roche announced it would invest $50 billion in the U.S. over the next five years. These investments further strengthen Roche's already significant U.S. footprint, which includes 13 manufacturing and 15 R&D sites across the Pharmaceutical and Diagnostics Divisions. The investment is expected to create over 12,000 new jobs, including nearly 6,500 construction jobs and 1,000 jobs at new and expanded facilities. Price Action: RHHBY stock is trading higher by 1.83% to $40.25 at last check Friday. Read Next:Photo by OleksSH via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article Roche's Multiple Sclerosis Drug Shows Low Disease Activity Over Two Years originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-05-2025
- Business
- Yahoo
Ten-Year Data From Roche's Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17%
Roche Holdings AG (OTC:RHHBY) on Tuesday released statistically significant final overall survival (OS) results from the phase III APHINITY study in people with human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer. After ten years, the risk of death was reduced by 17% for people treated with Perjeta (pertuzumab), Herceptin (trastuzumab), and chemotherapy (the Perjeta-based regimen) for a year as post-surgery (adjuvant) treatment, compared with individuals who received Herceptin, chemotherapy, and placebo. Also Read: After ten years, results show: 91.6% of people treated with the Perjeta-based regimen were alive at ten years versus 89.8% of those treated with Herceptin, chemotherapy, and placebo (hazard ratio [HR]=0.83, p-value=0.044). A 21% reduction in the risk of death was seen in the prespecified subgroup of people with lymph node-positive disease (HR=0.79). The previously reported invasive disease-free survival (primary endpoint) benefit was maintained (HR=0.79), strengthening results from earlier APHINITY analyses. No benefit was seen in the node-negative subgroup. The safety profile, including cardiac safety, was consistent with previous studies, and no new or unexpected safety signals were identified. Full results will be presented at the 2025 European Society for Medical Oncology Breast Cancer Congress. In April, Sarepta Therapeutics, Inc. (NASDAQ:SRPT) and Roche temporarily halted several clinical studies for Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy in patients with Duchenne muscular dystrophy. The company reported a patient death following treatment with Elevidys, having suffered acute liver failure. In April, Roche's MUSETTE Phase 3 trial of a high dose of Ocrevus (ocrelizumab) intravenous infusion for relapsing multiple sclerosis did not meet its primary endpoint in showing additional benefit in slowing disability progression compared with the currently approved Ocrevus IV 600 mg dose. Price Action: RHHBY stock is trading at $38.34 at the last check on Tuesday. Read Next:Photo by OleksSH via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article Ten-Year Data From Roche's Breast Cancer Trial Shows Perjeta-Based Regimen Cuts Death Risk By 17% originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
09-04-2025
- Business
- Yahoo
Why Is Pharma Giant Roche Stock Trading Lower On Wednesday?
Roche Holdings AG (OTC:RHHBY) on Wednesday announced data from MUSETTE Phase 3 trial of a high dose of Ocrevus (ocrelizumab) intravenous (IV) infusion in adult patients with relapsing multiple sclerosis (RMS) compared with the currently approved Ocrevus IV 600 mg dose. Patients received treatment with Ocrevus high dose or IV 600 mg every 24 weeks for a minimum of 120 weeks. The trial did not meet its primary endpoint in showing additional benefit in slowing disability progression, as measured by a composite disability over a period of at least 120 weeks of treatment. Also Read: The rates of disability progression were low and consistent with rates observed in the previous pivotal studies of Ocrevus IV 600 mg. In addition, in several predefined analyses on disease activity, Ocrevus IV 600 mg showed clinically meaningful results with the lowest annualized relapse rate (ARR) observed during the double-blind period of a Phase III study in RMS. The MUSETTE data further support the efficacy and safety profile of the currently approved OCREVUS IV 600 mg dose for RMS. Ocrevus IV and Ocrevus subcutaneous (SC; marketed as OCREVUS ZUNOVO [ocrelizumab hyaluronidase-ocsq] in the U.S.) are approved for both RMS (including relapsing-remitting multiple sclerosis and active, or relapsing secondary progressive multiple sclerosis, as well as clinically isolated syndrome in the U.S.) and primary progressive multiple sclerosis. Both Ocrevus IV and subcutaneous are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart, with subsequent doses given as single 600 mg infusions. Ocrevus subcutaneous is given as a single 920 mg subcutaneous injection every six months. Price Action: RHHBY stock is down 3.89% at $39.48 at the last check Wednesday. Read Next:Photo by OleksSH via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article Why Is Pharma Giant Roche Stock Trading Lower On Wednesday? originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
