ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

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.

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.