Roche Hldg Stock Price, News & Analysis

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.

Genentech, part of the Roche Group, received an 11 to 2 vote from the FDA’s Oncologic Drugs Advisory Committee in favor of Polivy (polatuzumab vedotin-piiq) combined with R-CHP for treating untreated diffuse large B-cell lymphoma (DLBCL). This marks the first treatment in 20 years to show significant improvement in progression-free survival over standard therapy. The FDA will decide on the supplemental Biologics License Application by April 2, 2023. Polivy has already been approved in over 60 countries for DLBCL. With findings indicating a 27% reduction in disease progression compared to R-CHOP, this treatment offers new hope for DLBCL patients.

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.