Roche Hldg - RHHBY STOCK NEWS

Roche announced FDA approval for Susvimo (ranibizumab injection), the first alternative to monthly eye injections for treating neovascular age-related macular degeneration (nAMD) in 15 years. Susvimo's implant allows for continuous drug delivery, potentially reducing treatment frequency to just two times a year. It serves approximately 20 million global nAMD patients. The FDA's decision was based on the positive Archway study, showing Susvimo maintained vision gains similar to monthly injections, although it posed a higher risk of endophthalmitis.

Roche has received FDA approval for the VENTANA PD-L1 (SP263) Assay as a companion diagnostic for Tecentriq in non-small cell lung cancer (NSCLC). This test identifies patients likely to benefit from Tecentriq after surgery and chemotherapy, aiming to improve personalized healthcare. The IMpower010 study indicated a 34% reduction in disease recurrence among patients with PD-L1 expression. Lung cancer accounts for over 2.2 million new diagnoses globally each year, reinforcing the importance of such advancements in treatment options.

Roche reported an 8% increase in group sales to CHF 46.7 billion for the first nine months of 2021, driven by strong demand for COVID-19 tests and growth in recently launched medicines. The Diagnostics Division experienced a remarkable 39% growth in sales, while the Pharmaceuticals Division sales remained stable. Key highlights included FDA approvals for Tecentriq and faricimab, and Breakthrough Therapy Designation for gantenerumab. Roche also raised its sales outlook for 2021, anticipating mid-single digit growth. The company's robust product pipeline includes 17 compounds in late-stage development.

Roche has partnered with Ibex Medical Analytics to enhance digital pathology using AI-based tools focused on cancer diagnostics. This collaboration aims to integrate Ibex's advanced image analysis capabilities into Roche's NAVIFY Digital Pathology platform. The partnership will enable pathologists to improve diagnostic efficiency and accuracy, particularly in breast and prostate cancer detection. Ibex's Galen™ platform has recently received FDA Breakthrough Device Designation, increasing confidence in the technology. Roche remains committed to advancing pathology through innovative partnerships and solutions.

Roche has received FDA approval for Tecentriq as the first cancer immunotherapy for the adjuvant treatment of Stage II-IIIA NSCLC. The decision follows the Phase III IMpower010 study, demonstrating a 34% reduction in disease recurrence risk for patients with PD-L1≥1% tumors compared to best supportive care. This approval introduces new treatment options for patients, marking a significant milestone in lung cancer therapy. Tecentriq is currently available in multiple dosing options and has shown clinical benefits across various lung cancer types.

Roche has partnered with PathAI to leverage artificial intelligence in advancing pathology imaging, enhancing diagnostic accuracy for cancer patients. The collaboration will integrate PathAI’s algorithms into Roche’s NAVIFY Digital Pathology platform, enabling pathologists to access cutting-edge AI tools for improved treatment decisions. This agreement expands Roche’s Digital Pathology Open Environment, supporting the development of companion diagnostics and drug programs across multiple cancer types.

Chugai Pharmaceutical announced new data showing Enspryng's long-term efficacy in preventing relapses in patients with NMOSD. Over four years, 73% of patients in the SAkuraStar study and 71% in the SAkuraSky study remained relapse-free. The safety profile remains consistent across treatment periods, with no new safety signals. Enspryng allows for self-administration, enhancing treatment accessibility. Additionally, the company is launching the SAkuraBONSAI study to further explore disease progression in treatment-naïve patients.

Roche announced positive long-term efficacy results for ENSPRYNG (satralizumab) in preventing relapses in patients with neuromyelitis optica spectrum disorder (NMOSD). Data from the SAkuraStar and SAkuraSky studies show that over 70% of treated individuals remained relapse-free after four years. With a favorable safety profile, ENSPRYNG is now approved in 58 countries, including the U.S. and the EU. New studies, like SAkuraBONSAI, are being initiated to further evaluate its effectiveness and safety.

Roche has received European Medicines Agency (EMA) approval for a 90-minute infusion of Gazyvaro® (obinutuzumab), a significant reduction from the standard 3-4 hour infusion time. This change aims to enhance patient convenience and reduce healthcare system pressures, especially post-COVID-19. The GAZELLE study confirmed no new safety concerns with the shorter infusion. Gazyvaro is already approved for treating follicular lymphoma (FL) and other indications, further solidifying its role in improving patient treatment experiences.