Roche Hldg - RHHBY STOCK NEWS

Roche (RHHBY) has received FDA approval for a new tablet formulation of Evrysdi (risdiplam), the only non-invasive disease-modifying treatment for Spinal Muscular Atrophy (SMA). The 5 mg tablet, approved for patients two years and older weighing over 20 kg, can be swallowed whole or dispersed in water and stored at room temperature.

A bioequivalence study demonstrated that the tablet provides comparable exposure to risdiplam as the original oral solution, ensuring the same efficacy and safety profile. The oral solution will remain available for patients on other doses or those who prefer it. The new tablet formulation is expected to be available in the coming weeks.

Evrysdi is currently approved in over 100 countries, offering simplified dose administration that may provide greater freedom and independence for SMA patients in their daily activities such as working, traveling, and education.

Genentech, a Roche Group member, announced FDA approval for Evrysdi® (risdiplam) tablet, the first and only tablet treatment for spinal muscular atrophy (SMA). The new 5 mg tablet, which can be swallowed whole or dispersed in water, provides the same efficacy and safety as the current oral solution and can be stored at room temperature.

The approval was based on a bioequivalence study confirming comparable exposure to risdiplam between the tablet and oral solution formulations. The tablet is suitable for patients 2 years or older weighing more than 44 lbs (20 kgs). Evrysdi, approved in over 100 countries, is the only non-invasive disease-modifying SMA treatment available.

The oral solution will remain available for patients on other doses or those who prefer it. The new tablet formulation aims to provide greater independence and convenience for SMA patients through simplified dose administration.

Roche announced significant results from its phase III REGENCY trial of Gazyva/Gazyvaro in treating lupus nephritis, published in the New England Journal of Medicine. The study showed that 46.4% of patients receiving Gazyva/Gazyvaro plus standard therapy achieved complete renal response (CRR) at 76 weeks, compared to 33.1% with standard therapy alone.

The treatment demonstrated consistent benefits across patient subgroups and showed improvements in complement levels and reductions in disease activity markers. Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a phase III study to show CRR benefit. The safety profile aligned with previous observations in hematology-oncology indications.

Key secondary endpoints revealed higher proteinuric response rates and better CRR with successful corticosteroid reduction in the Gazyva/Gazyvaro group. The drug previously received FDA Breakthrough Therapy Designation in 2019 based on phase II NOBILITY study data.

Genentech announced significant results from its Phase III REGENCY trial of Gazyva (obinutuzumab) for active lupus nephritis, published in the New England Journal of Medicine. The study showed that 46.4% of patients treated with Gazyva plus standard therapy achieved complete renal response (CRR) at 76 weeks, compared to 33.1% with standard therapy alone.

The trial demonstrated consistent benefits across patient subgroups, with improvements in complement levels and reductions in disease activity markers. Key secondary endpoints revealed that patients receiving Gazyva were more likely to achieve CRR with successful corticosteroid reduction and showed improved proteinuric response versus standard therapy alone.

Gazyva is the only anti-CD20 monoclonal antibody to demonstrate CRR benefit in a Phase III lupus nephritis study. The drug's safety profile remained consistent with its known profile in hematology-oncology indications.

Genentech, a Roche Group member, announced FDA approval of Susvimo (ranibizumab injection) for treating diabetic macular edema (DME), which affects over 29 million adults worldwide. This marks Susvimo's second FDA-approved indication, following its 2021 approval for wet age-related macular degeneration.

The approval is based on the Phase III Pagoda study's one-year results, where Susvimo demonstrated non-inferior vision improvements compared to monthly ranibizumab injections (9.6 vs 9.4 eye chart letters). Notably, Susvimo requires only two treatments per year through its Port Delivery Platform, offering a significant advantage over current treatments that may need monthly injections.

The company is providing comprehensive access and reimbursement support services through Genentech Access Solutions for eligible patients.

Roche (RHHBY) has received FDA approval for Susvimo to treat diabetic macular edema (DME), marking its second indication after wet age-related macular degeneration. DME affects over 29 million adults worldwide and is a leading cause of vision loss in diabetic adults.

The treatment offers a groundbreaking continuous delivery system requiring only two treatments per year, compared to traditional monthly eye injections. The approval is based on the phase III Pagoda study results, where Susvimo demonstrated non-inferior vision improvements compared to monthly ranibizumab injections (9.6 vs 9.4 eye chart letters).

Susvimo's Port Delivery Platform provides continuous medication delivery, offering a more convenient alternative to current treatments that may require monthly injections. The product is now available to US retina specialists and their DME patients.

Roche has received FDA approval for an expanded use of its PATHWAY HER2 (4B5) test, making it the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU treatment. This advancement is particularly significant as approximately 20-25% of hormone receptor-positive, HER2-negative breast cancer patients may be classified as HER2-ultralow.

The DESTINY-Breast06 trial demonstrated promising results, showing a median progression-free survival of 13.2 months with ENHERTU compared to 8.1 months with standard chemotherapy. This test expansion builds upon Roche's 2022 approval for HER2-low status assessment, further strengthening their position in HER2 diagnostics and expanding treatment options for breast cancer patients.

Roche reported strong 2024 results with 7% sales growth to CHF 60.5 billion, driven by robust demand in both medicines and diagnostics. Excluding COVID-19 impact, Group sales increased by 9%, marking the third consecutive quarter of 9% growth.

The Pharmaceuticals Division saw 8% growth to CHF 46.2 billion, led by newer medicines like Vabysmo, Phesgo, Ocrevus, and Hemlibra, which achieved combined sales of CHF 16.9 billion. The Diagnostics Division grew 4% to CHF 14.3 billion, with base business increasing 8%.

Core operating profit rose 14% to CHF 20.8 billion, while IFRS net income decreased 19% to CHF 9.2 billion due to impairment charges related to Flatiron Health and Spark Therapeutics. The company proposes a dividend increase to CHF 9.70, marking the 38th consecutive increase.

For 2025, Roche expects mid-single-digit sales growth and high-single-digit core earnings per share growth.

Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced that Wafaa Mamilli will join as Chief Digital Technology Officer (CDTO) and member of the enlarged Corporate Executive Committee, effective February 10, 2025. Based at Genentech in South San Francisco, Mamilli will take over the worldwide Informatics function from Alan Hippe, who will retain his role as Chief Financial Officer (CFO).

The split of the CFO and Chief Informatics Officer roles reflects Roche's increased focus on digital transformation and AI implementation across the enterprise. Mamilli joins from Zoetis, where she served as Chief Digital & Technology Officer and Group President for China, Brazil and Precision Animal Health. She previously spent over 20 years at Eli Lilly, ultimately as global CIO for the company's business units.