ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announces FDA approval for the VENTANA PD-L1 (SP263) Assay, enabling identification of non-small cell lung cancer (NSCLC) patients eligible for Libtayo treatment. This approval expands access to immunotherapy for patients with locally advanced and metastatic NSCLC, a group comprising over 60% of NSCLC diagnoses.

The assay is vital for guiding clinical decisions and optimizing patient outcomes. It is uniquely positioned as the only FDA-approved product for NSCLC across four immunotherapy options, aimed at improving treatment pathways for lung cancer, which remains the leading cause of cancer death worldwide.

Roche has received FDA approval for the VENTANA PD-L1 (SP263) Assay, enhancing access to Libtayo (cemiplimab) for patients with non-small cell lung cancer (NSCLC). This assay identifies those eligible for treatment, expanding options for over 60% of diagnosed NSCLC patients at advanced stages. This advancement is crucial as lung cancer remains the top cause of cancer deaths globally, with over 2.2 million diagnoses annually.

The VENTANA assay is unique, providing indications for four different immunotherapies, and underpins the importance of personalized medicine in improving patient outcomes.

Roche has expanded its collaboration with the U.S. Centers for Disease Control and Prevention (CDC) to enhance laboratory capabilities in regions severely impacted by HIV and tuberculosis. This initiative, known as Lab Networks for Health, aims to improve detection, prevention, and treatment outcomes in selected African, Eastern European, and Central Asian countries. The partnership will focus on workforce development, quality management systems, and multi-pathogen testing. With approximately 2 billion people infected with tuberculosis and over 38 million living with HIV, strengthening laboratory networks is essential for public health.

Roche (OTCQX: RHHBY) announced an expanded partnership with the U.S. CDC, aiming to strengthen laboratory capabilities in countries impacted by HIV and tuberculosis. The "Lab Networks for Health" initiative focuses on enhancing diagnostics and treatment outcomes through public-private collaboration in Africa, Eastern Europe, Central Asia, and the Western Hemisphere. Key efforts include workforce training, quality management systems, and optimizing diagnostic networks for better pandemic preparedness. This collaboration is crucial as global health challenges persist, evidenced by millions undiagnosed with HIV and TB. The initiative supports WHO goals for disease elimination.

Roche has launched the IDH1 R132H and ATRX Rabbit Polyclonal Antibodies to enhance the diagnosis of brain cancer mutations. These additions to Roche's neuropathology portfolio aim to improve patient care by enabling clinicians to stratify treatments based on IDH1 and ATRX gene mutation statuses. The IDH1 R132H mutation is linked to better prognosis and eligibility for clinical trials. These tests, optimised for the BenchMark series, are designed to be more accurate and cost-effective than traditional sequencing methods. Initially available in the US, they will expand to other markets later this year and in 2024.

On February 10, 2023, Roche (OTCQX: RHHBY) announced its Roche Long Term Foundation acquired 540,000 bearer shares through an accelerated book building process. This acquisition is intended to meet both current and future obligations from equity compensation plans. The sale also involved a member of a shareholder group, which sold 2.7 million shares, reducing their ownership from 67.5% to approximately 65% of Roche's total issued shares. Roche continues to be a leader in biotechnology and diagnostics and has been recognized for its sustainability efforts in the pharmaceuticals industry.

Roche reported positive data for Vabysmo (faricimab) from two phase III trials, BALATON and COMINO, evaluating its efficacy for macular edema due to retinal vein occlusion (RVO). In both trials, Vabysmo achieved non-inferior visual acuity gains compared to aflibercept. The studies showed a significant reduction in retinal fluid, indicating effective treatment outcomes. If approved, RVO will be the third indication for Vabysmo, which is already authorized for neovascular age-related macular degeneration and diabetic macular edema. The findings will be submitted for regulatory review globally, including by the FDA and EMA.

Roche (OTC-PINK:RHHBY) has expanded its collaboration with Janssen Biotech to enhance the development of companion diagnostics aimed at personalised healthcare. This new agreement, announced on February 9, 2023, will include a diverse range of technologies such as blood and tissue biomarkers, digital pathology, and next-generation sequencing. The collaboration aims to improve access to targeted treatment options for patients, exemplifying Roche's commitment to precision medicine. Successful projects may include new immunohistochemistry assays and advanced data analysis for patient identification.

Roche has expanded its collaboration with Janssen Biotech to enhance personalized healthcare through the development of companion diagnostics. The agreement includes a wide range of technologies such as immunohistochemistry, digital pathology, and next-generation sequencing. This collaboration aims to improve access to targeted treatment options, thereby strengthening Roche's position in precision medicine. The partnership also looks to explore innovative projects like data analysis and the development of new assays for patient enrollment in personalized treatments.