ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech, a member of Roche, announces new partnerships to enhance brain health outcomes. These initiatives aim to assess the complexities and economic impacts of neurological diseases. Key data presented include results showing delayed disability in multiple sclerosis (MS) patients treated with Ocrevus and reduced disease activity with Enspryng in neuromyelitis optica spectrum disorder (NMOSD). Evrysdi also shows significant benefits for spinal muscular atrophy (SMA). Genentech invests over $14.7 billion in R&D, with 20% dedicated to addressing brain health disorders. They will present 33 abstracts at the upcoming American Academy of Neurology meeting, highlighting long-term treatment data and ongoing research initiatives. Genentech aims to build resilient health systems and improve patient outcomes.

Genentech, a part of Roche Group (OTCQX: RHHBY), announced FDA approval for Polivy® (polatuzumab vedotin-piiq) in combination with R-CHP, marking the first new first-line treatment for diffuse large B-cell lymphoma (DLBCL) in nearly 20 years. The pivotal POLARIX trial demonstrated a 27% reduction in the risk of disease progression compared to the standard R-CHOP treatment. Approximately 31,000 DLBCL diagnoses are projected in the U.S. in 2023, with a significant number of patients experiencing relapse. This approval shifts Polivy’s status from accelerated to regular approval, enhancing access to a therapy that may improve patient outcomes significantly.

Roche has received FDA approval for Polivy in combination with Rituxan and other agents for treating diffuse large B-cell lymphoma (DLBCL), marking the first new therapy for this aggressive cancer in nearly 20 years. The combination showed a 27% reduction in disease progression risk in the POLARIX trial compared to the standard R-CHOP regimen, with a similar safety profile.

This approval transitions Polivy from accelerated to regular approval, expanding treatment options for the estimated 31,000 new DLBCL cases expected in the U.S. in 2023. Roche is exploring further studies to enhance Polivy's effectiveness, indicating a strong potential for market growth and improved patient outcomes.

Roche has announced groundbreaking results from the Phase III IMbrave050 study, showing that the combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) significantly reduced the risk of disease recurrence in patients with hepatocellular carcinoma (HCC) following surgery. Specifically, the combination therapy resulted in a 28% reduction in recurrence risk compared to active surveillance, demonstrating its efficacy in high-risk patients. With up to 80% of HCC patients experiencing recurrence post-surgery, these results herald a potential shift in treatment standards. The findings will be presented at the AACR Annual Meeting 2023, with ongoing discussions with health authorities about future steps.

Roche (OTCQX: RHHBY) announced new data for Vabysmo at the 2023 ARVO Annual Meeting, showcasing promising results in treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Key findings indicate that Vabysmo promotes rapid fluid drying compared to aflibercept, enhancing visual acuity while allowing extended treatment intervals early in therapy. Real-world studies suggest most patients can extend dosing intervals while maintaining vision. Additionally, Roche will present initial phase I data on an investigational anti-IL-6 treatment, which may improve outcomes for patients with uveitic macular edema (UME). The company remains dedicated to advancing therapies for vision-threatening retinal conditions.

Roche has announced a collaboration with Eli Lilly to advance the development of its Elecsys Amyloid Plasma Panel (EAPP), which aims to facilitate earlier Alzheimer’s disease diagnosis. Currently, about 75% of symptomatic individuals remain undiagnosed for an average of 2.8 years. The collaboration aims to improve diagnosis accuracy and access to treatments. The EAPP has received Breakthrough Device Designation from the FDA and will help identify patients unlikely to have amyloid pathology, expediting further evaluations. The global dementia population is expected to rise from 55 million to nearly 140 million by 2050, underscoring this initiative's importance.

Roche (OTCQX: RHHBY) announced long-term data from the pivotal SUNFISH study for Evrysdi® (risdiplam), showing sustained increases in motor function in individuals aged 2-25 with Type 2 and non-ambulant Type 3 spinal muscular atrophy (SMA) over four years. The overall rate of adverse events decreased during this period. More than 8,500 patients have been treated with Evrysdi, which is approved in over 90 countries. The data, presented at the MDA Clinical Conference, reinforces Evrysdi's long-term efficacy and safety profile, indicating its significant impact on daily living activities for SMA patients.

On March 14, 2023, Roche (OTCQX: RHHBY) held its Annual General Meeting, where all proposals by the Board of Directors were approved, including the election of Severin Schwan as the new Chairman. Thomas Schinecker was appointed as the new CEO. Shareholders approved a dividend increase to CHF 9.50 per share, marking the 36th consecutive rise. The meeting also ratified the actions of the Board and authorized future remuneration for its members. KPMG AG was appointed as the external auditor for 2023. The company continues to focus on enhancing healthcare outcomes through innovative diagnostics and pharmaceuticals.

The U.S. FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 in favor of Roche's Polivy (polatuzumab vedotin-piiq) combined with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). This marks the first groundbreaking treatment in two decades, showing significant improvement in progression-free survival against the standard R-CHOP. The FDA is expected to decide on the supplemental application by April 2, 2023. DLBCL, the most prevalent form of non-Hodgkin lymphoma, has seen limited advancements in treatment outcomes. Polivy's combination therapy was also recognized as a preferred option in NCCN Clinical Practice Guidelines.