Roche Hldg - RHHBY STOCK NEWS

Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Evrysdi for treating spinal muscular atrophy (SMA) in patients aged two months and older. This recommendation is based on positive outcomes from pivotal trials: FIREFISH and SUNFISH, showcasing significant motor function improvements. With over 2,500 patients treated, Evrysdi aims to fill the therapeutic gap in SMA care. The final approval decision is expected from the European Commission in two months, affecting all EU member states and select countries.

Roche announced that data from the FIREFISH Part 1 study published in the New England Journal of Medicine shows that after 12 months of treatment with Evrysdi, 90% of infants survived without permanent ventilation. Additionally, 33% of infants could sit unsupported for at least 5 seconds, a significant motor milestone. Evrysdi, FDA-approved in August 2020 as the first oral treatment for SMA, has shown a median increase of 1.9-fold in SMN protein levels. Despite some serious adverse events, no fatalities were attributed to Evrysdi.

Genentech, part of the Roche Group, announced publication of Evrysdi™ (risdiplam) data from the pivotal FIREFISH study. The study showed that 90% of infants with symptomatic Type 1 spinal muscular atrophy (SMA) survived without permanent ventilation after 12 months of treatment. Additionally, 33% of infants could sit independently for at least 5 seconds. The data highlights the drug's effectiveness in increasing survival of motor neuron (SMN) protein levels. Evrysdi, FDA-approved in August 2020, has promising implications for treating SMA in infants.

Genentech has announced positive results from four Phase III studies on its investigational bispecific antibody, faricimab, targeting diabetic macular edema (DME) and wet age-related macular degeneration (nAMD). Faricimab demonstrated non-inferior vision gains compared to aflibercept, with patients able to extend treatment intervals up to four months. Approximately 52.8% of DME patients and 45.7% of nAMD patients achieved four-month dosing in the first year. The studies showed no unexpected safety signals, indicating faricimab may improve treatment adherence and outcomes.

Roche announced positive results from four phase III studies of its investigational bispecific antibody, faricimab, for treating diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). Approximately 50% of patients could be treated every four months, with about 75% treated every three months or longer. Faricimab showed non-inferior vision gains compared to aflibercept and demonstrated consistent improvements in anatomical outcomes. If approved, it would be the first new treatment for nAMD in 15 years and for DME in nearly a decade.

Roche has received FDA 510K clearance for stabilised urine samples with its cobas® BKV Test, marking a significant advancement in managing BK virus (BKV) in transplant patients. This non-invasive test allows easier collection and storage of urine samples, enhancing diagnosis capabilities. The test is critical as BKV can cause severe complications in immunocompromised patients, often indicated by higher BKV DNA levels in urine. Roche aims to provide standardized solutions for monitoring infection risks, furthering its commitment to improving transplant patient care.

On February 8, 2021, Roche announced submission for Emergency Use Authorization (EUA) for a SARS-CoV-2 Rapid Antigen Test aimed at healthcare professionals in point-of-care settings. This test allows for rapid identification of COVID-19 infections within 15 minutes using a nasal swab, providing vital resources where PCR tests are unavailable. Roche anticipates producing tens of millions of tests monthly in the U.S. and will also offer NAVIFY® Pass, a digital solution for sharing diagnostic results. This initiative is part of Roche's broader response to enhance COVID-19 testing capabilities.

Roche has received FDA's Breakthrough Device Designation for its Elecsys® GDF-15 assay, a companion diagnostic for identifying cachectic patients with solid tumors eligible for treatment with Pfizer’s investigational drug PF-06946860. Cachexia affects over 30 million globally, significantly impairing the quality of life and increasing mortality risks among cancer patients. This partnership aims to enable precision medicine approaches, ensuring effective treatment for patients suffering from cachexia, thus enhancing cancer therapy outcomes.

Roche reported a 1% increase in group sales at constant exchange rates for 2020, despite a 5% decline in Swiss francs due to currency appreciation. The Pharmaceuticals Division experienced a 2% decline in sales, hindered by competition from biosimilars and missed COVID-19 medical appointments. Conversely, the Diagnostics Division surged by 14%, driven by COVID-19 diagnostics. Roche's IFRS net income rose by 17% to CHF 15.1 billion.

An increase in dividends to CHF 9.10 is proposed, pending shareholder approval.