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 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.
Roche announced new data from its haemophilia A clinical program to be presented at the ISTH 2021 Congress from July 17-21, 2021. The final analysis of the phase IIIb STASEY study will affirm Hemlibra's safety and efficacy for patients with factor VIII inhibitors. Spark Therapeutics will share updated results from the phase I/II trial of SPK-8011, showing durable factor VIII expression for up to four years. Both studies highlight Roche's commitment to advancing therapies for haemophilia A, demonstrating significant reductions in annualized bleed rates and confirming a favorable safety profile.
Roche has received European Commission approval for ENSPRYNG (satralizumab), the first treatment for adults and adolescents with AQP4-IgG seropositive NMOSD. This therapy can be used alone or alongside immunosuppressive therapy to reduce relapses and prevent disability. In clinical trials, ENSPRYNG significantly lowered the number and severity of relapses compared to placebo, achieving 83% relapse-free status at 48 weeks in monotherapy and 92% when combined with IST. The treatment is designed for subcutaneous administration every four weeks, enhancing accessibility for patients.
Roche (OTCQX: RHHBY) received Emergency Use Authorization (EUA) from the FDA for its drug Actemra/RoActemra, aimed at treating hospitalized COVID-19 patients requiring respiratory support. This authorization is based on four randomized studies involving over 5,500 patients, suggesting improved outcomes with the drug. The common adverse effects reported were constipation, anxiety, and nausea. While the EUA is a temporary measure during the pandemic, it positions Actemra/RoActemra as a potentially key therapeutic option for affected patients.
Genentech, part of Roche Group, announced that the FDA has granted an Emergency Use Authorization (EUA) for Actemra® (tocilizumab) to treat COVID-19 in hospitalized patients aged 2 and older. The EUA is based on data from four studies involving over 5,500 patients, suggesting that Actemra may improve outcomes for those on systemic corticosteroids requiring oxygen or ventilation support. Despite not being FDA-approved for this use, the EUAs enable access during the pandemic, highlighting ongoing challenges in managing severe COVID-19 cases.
Roche's Port Delivery System (PDS) for neovascular age-related macular degeneration (nAMD) has received FDA acceptance for Priority Review. If approved by October 23, 2021, PDS would be the first implant providing continuous drug delivery, allowing up to six months between treatments, significantly reducing the need for frequent injections. The pivotal Archway study demonstrated that over 98% of patients could go without additional treatment for six months, achieving equivalent vision outcomes compared to monthly injections. The European Medicines Agency has also validated the PDS Marketing Authorisation Application for nAMD.