ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech (RO, ROG; RHHBY) collaborates with NVIDIA to leverage AI for drug discovery and development. The multi-year strategic research collaboration aims to accelerate the delivery of novel therapies and medicines to people by transforming AI models and algorithms into a next-generation AI platform.

Roche (SIX: RO, ROG; OTCQX: RHHBY) launches the LightCycler PRO System, an advanced qPCR technology designed for clinical diagnostics and research. The system aims to advance personalized healthcare and support outbreak readiness, offering agility and flexibility for translational research and diagnostics. It utilizes gold standard technology for quality, precision, and reliability, critical for accurate patient diagnosis and clinical decisions.

Roche (SIX: RO, ROG; OTCQX: RHHBY) launches Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for hepatitis E virus (HEV) infections, contributing to global disease management. The tests aid in timely diagnosis, treatment, and surveillance, aligning with WHO's Essential Diagnostics List. They support patient care, disease burden estimation, and outbreak management, providing results in 18 minutes.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC) Tecentriq® (atezolizumab). Tecentriq SC would be the first injectable PD-(L)1 cancer immunotherapy in the EU, potentially cutting treatment time by approximately 80%. The recommendation is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. The SC formulation is recommended for all indications in which Tecentriq IV has been previously approved, including certain types of lung, liver, bladder, and breast cancer. The subcutaneous administration offers a faster and more convenient alternative to IV infusion, potentially freeing up time for patients, healthcare teams, and caregivers. Tecentriq SC recently received its first marketing authorization in Great Britain and was developed to provide patients with an alternative to the IV administration of Tecentriq and the potential for treatment outside of the hospital setting. The CHMP's positive opinion brings Roche a step closer to offering the first subcutaneous PD-L1 cancer immunotherapy treatment to patients in the EU.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that its Elecsys® Neurofilament Light Chain (NfL) test for Multiple Sclerosis (MS) received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The test aids in detection of disease activity in adults with MS, offering a minimally invasive testing option with the potential to provide patient insights for other neurological conditions. This supports better disease management decisions and addresses significant gaps in access to testing.

Roche announces topline results from the Phase 3 EMBARK study of Elevidys in boys with Duchenne muscular dystrophy aged 4-7 years. Elevidys-treated patients showed improvement in motor function compared to placebo, with statistically significant treatment benefits observed in secondary functional endpoints. No new safety signals were observed. Further evaluation of data is ongoing.

The FDA has approved Vabysmo for the treatment of macular edema following retinal vein occlusion. Vabysmo is the first and only bispecific antibody approved for the eye. The approval is based on positive results from Phase III studies showing early and sustained vision improvements. Vabysmo also demonstrated rapid and robust drying of retinal fluid. Safety results were consistent with previous trials.

Roche's Vabysmo receives FDA approval for the treatment of macular edema following retinal vein occlusion (RVO). Vabysmo is now approved for three indications, including neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The approval is based on positive results from phase III studies showing early and sustained vision improvements that were non-inferior to aflibercept, as well as rapid and robust drying of retinal fluid. The U.S. label update includes information on rare post-marketing reports of retinal vasculitis and/or retinal vascular occlusion, with a reporting rate in line with other intravitreal treatments.

Roche collaborates with Ibex and Amazon Web Services to offer AI algorithms for breast and prostate cancer diagnosis through the navify Digital Pathology software platform. This collaboration aims to improve patient care and advance personalized healthcare.