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.
Roche announced that the pivotal phase III POLARIX trial for Polivy in combination with chemotherapy regimen R-CHP has met its primary endpoint, showing significantly improved progression-free survival in previously untreated diffuse large B-cell lymphoma (DLBCL) patients compared to standard treatment R-CHOP. Given that 40% of DLBCL patients relapse, this outcome could transform first-line treatment. Roche plans to submit these results to health authorities globally and will present them at an upcoming medical meeting.
Roche has received FDA acceptance for its supplemental Biologics License Application for Tecentriq (atezolizumab) as an adjuvant treatment for non-small cell lung cancer (NSCLC). The application is based on Phase III IMpower010 study results, demonstrating a 34% reduction in disease recurrence or death in patients with PD-L1-positive NSCLC compared to best supportive care. The FDA's review falls under the Real-Time Oncology Review program, aiming for expedited availability of effective treatments. A decision is expected by December 1, 2021.
Roche announced that the FDA has accepted its Biologics License Application for faricimab, targeting neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) under Priority Review. Faricimab could be the first bispecific antibody for eye treatments, addressing two pathways implicated in retinal diseases. Phase III trials showed that nearly half of patients could extend treatment intervals to four months, maintaining vision gains comparable to the standard care, aflibercept. The European Medicines Agency has also validated the marketing application for faricimab.
Roche announced positive results from the FIREFISH Part 2 study, demonstrating that Evrysdi significantly benefits infants aged 1-7 months with Type 1 spinal muscular atrophy (SMA). By month 12, 29% of infants could sit unsupported, while 93% remained alive, and 85% were free from permanent ventilation. The study showed promising motor milestone improvements with Evrysdi, and safety was consistent with established profiles. RHHBY has treated over 4,000 patients globally, revealing Evrysdi’s potential in addressing SMA, a leading genetic cause of infant mortality.
Genentech announced the publication of pivotal study results for Evrysdi (risdiplam) in Type 1 spinal muscular atrophy (SMA) in the New England Journal of Medicine. In the FIREFISH Part 2 study, 29% of infants (12/41) achieved the significant motor milestone of sitting unsupported for at least 5 seconds by month 12. The treatment demonstrated consistent safety with 93% of infants alive and 85% free from permanent ventilation at the same time point. The drug is part of the collaboration with the SMA Foundation and is being evaluated in multiple trials worldwide.
Roche reported an 8% increase in Group sales at constant exchange rates for H1 2021, totaling CHF 30.7 billion. The Pharmaceuticals Division experienced a 3% sales decline, offset by a 51% surge in Diagnostics, driven by COVID-19 tests. Key highlights include positive study results for Tecentriq in lung cancer and new EU approvals for Venclyxto and Enspryng. Despite continued biosimilar challenges, new medicines recorded 30% growth. Roche maintains its 2021 outlook, expecting low to mid-single-digit sales growth. Core EPS rose by 6%, affirming the company's strong market position amid recovery signs in the Pharma Division.
Roche has received Breakthrough Therapy Designation (BTD) from the FDA for Venclexta® (venetoclax) in combination with azacitidine, targeting previously untreated higher-risk myelodysplastic syndromes (MDS). With approximately 10,000 annual diagnoses in the U.S., MDS presents significant treatment challenges. This designation, based on the phase Ib M15-531 study, marks the 11th BTD for Roche's haematology portfolio and reinforces Venclexta's potential in blood cancer therapy. The median survival for higher-risk MDS patients is roughly 18 months, highlighting the urgent need for effective treatments.
On July 20, 2021, Roche announced full approval from Japan's Ministry of Health for Ronapreve (casirivimab and imdevimab) to treat mild to moderate COVID-19 via intravenous infusion. This approval is based on a global Phase III trial demonstrating a 70% reduction in hospitalization or death for high-risk non-hospitalized patients. The treatment retains efficacy against emerging variants, including Delta. The drug has gained emergency use authorization in the EU and the US, with ongoing assessments for broader application. Roche aims to ensure timely availability in Japan through collaboration with Chugai.
The final analysis from the phase IIIb STASEY study has demonstrated the continued safety and efficacy of Hemlibra (emicizumab) for treating individuals with haemophilia A who have inhibitors to factor VIII. The study, which included data from 193 participants, reported a zero treated bleed rate in 82.6% of patients, with no new safety signals identified over longer-term treatment. Common side effects included joint pain and cold symptoms, while anti-drug antibody incidence remained low. Hemlibra is approved in over 100 countries worldwide.
Roche (OTCQX: RHHBY) has announced the inclusion of its cobas® MTB and cobas® MTB-RIF/INH tests in updated WHO guidelines for tuberculosis diagnostics. These tests enhance the detection of TB and drug-resistant TB, thereby improving patient management in high-burden countries. With approximately 1.7 billion people affected by TB globally and 1.4 million deaths annually, this initiative aims to boost early detection and treatment, especially in vulnerable populations. Roche's Global Access Program further supports increased access to innovative diagnostics, benefiting patients significantly.