Roche Hldg - RHHBY STOCK NEWS

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.

Roche announced that the FDA has granted Emergency Use Authorization (EUA) for its cobas® SARS-CoV-2 Nucleic acid test, usable on the cobas® Liat® System. This significant milestone introduces the first real-time RT-PCR test capable of identifying SARS-CoV-2 infection within 20 minutes. The test will be available in July and can screen both symptomatic and asymptomatic individuals, enhancing access to rapid testing in various healthcare settings. Roche aims to support COVID-19 management and curb the virus's spread, marking a step forward in public health efforts.