Roche Hldg Stock Price, News & Analysis

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.

Roche announced positive topline results from the overall survival (OS) analysis of the phase III INAVO120 study for their Itovebi drug combination. The treatment, which combines Itovebi with palbociclib and fulvestrant, demonstrated statistically significant survival benefits for patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer.

The study met its key secondary endpoint, building upon previous primary analysis results which showed the Itovebi-based regimen reduced disease progression risk by 57% (15.0 vs 7.3 months). The FDA approved this treatment in October 2024 for endocrine-resistant cases.

Itovebi is currently being investigated in four phase III clinical studies (INAVO120-123) for various combinations in PIK3CA-mutated breast cancer. The full OS analysis results will be presented at an upcoming medical meeting.

Genentech announced positive topline results from the overall survival (OS) analysis of the Phase III INAVO120 study for Itovebi (inavolisib). The study, investigating Itovebi in combination with palbociclib and fulvestrant for PIK3CA-mutated, HR-positive, HER2-negative breast cancer, met its key secondary endpoint showing statistically significant OS benefit.

The primary analysis demonstrated that the Itovebi-based regimen reduced disease progression or death risk by 57% compared to the control group (15.0 vs 7.3 months). The FDA approved the Itovebi-based regimen in October 2024 for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer. The treatment is being investigated in four Phase III clinical studies.

Roche (RHHBY) announced positive two-year results from the EMBARK trial for Elevidys, its gene therapy for Duchenne muscular dystrophy (DMD). The study demonstrated statistically significant and clinically meaningful improvements across three key motor function measures compared to an untreated control group.

Key findings after two years of treatment include improvements in North Star Ambulatory Assessment (+2.88 points), Time to Rise (-2.06 seconds), and 10-meter walk/run (-1.36 seconds). The functional differences between treated individuals and the control group increased between years one and two.

Patients who crossed over from placebo to Elevidys in part two showed similar improvements after one year. Muscle biopsies taken at 64 weeks showed sustained micro-dystrophin expression, with MRI data supporting functional benefits. No new safety concerns were identified.

Elevidys is currently approved in multiple countries, including the US, UAE, Brazil, and Israel, with pending applications in Europe, Japan, and other regions.

Roche (RHHBY) has received FDA 510(k) clearance and CLIA waiver for its cobas® liat STI multiplex assay panels, enabling rapid diagnosis of multiple sexually transmitted infections from a single sample. The tests, which will be available in the U.S. market in coming months, can detect chlamydia, gonorrhea, and Mycoplasma genitalium.

The point-of-care tests utilize PCR technology and deliver results in 20 minutes, allowing healthcare providers to diagnose and treat patients in a single visit. This development is particularly significant as over 1 million people acquire curable STIs daily worldwide, with most cases being asymptomatic.

The tests will be initially launched in the U.S. market, with CE mark commercialization expected to follow. These solutions aim to improve healthcare efficiency, reduce unnecessary antibiotic usage, and enhance patient outcomes through immediate diagnosis and treatment.

Roche (RHHBY) has received FDA 510(k) clearance for its VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail, a groundbreaking test for diagnosing B-cell lymphoma. This follows its CE Mark approval in June 2024. The test is the first clinically approved in-situ hybridisation (ISH) test capable of assessing all B-cell lymphoma subtypes.

The highly-sensitive test helps distinguish between B-cell cancer and normal immune responses, enabling faster diagnosis and treatment initiation. It can evaluate over 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide, working with small biopsies and formalin-fixed tissue. This reduces the need for fresh tissue samples and additional biopsies.

B-cell lymphoma represents about 85% of non-Hodgkin lymphoma (NHL) cases, with NHL being one of the most common cancers in the US, accounting for 4% of all cancer cases and causing over 80,000 deaths annually.