ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche announced that William Pao, Head of Pharma Research and Early Development (pRED) since 2018, will leave the company effective 18 March 2022. He will be succeeded by Hans Clevers, a current board member, who will also join the Corporate Executive Committee. CEO Severin Schwan expressed confidence in Clevers' leadership, highlighting Pao's contributions to diversifying Roche's R&D portfolio. Hans Clevers, a notable figure in molecular genetics, brings extensive scientific expertise to his new role, suggesting a continued commitment to advancing personalized healthcare.

Roche announced the FDA's approval of Vabysmo (faricimab-svoa) for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), marking it as the first injectable eye medicine approved for both conditions. With the capability of administering injections every two to four months after initial treatment, Vabysmo targets Ang-2 and VEGF-A pathways linked to vision loss. Positive phase III study results indicated non-inferior vision gains compared to existing treatments, affirming its potential to reduce treatment burden for patients.

Genentech announced FDA approval of Vabysmo (faricimab-svoa) for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME). This is the first injectable eye medicine approved for both conditions, offering flexible dosing intervals of one to four months after initial monthly doses. Vabysmo targets angiopoietin-2 and VEGF-A, crucial pathways in vision loss. In clinical trials, Vabysmo demonstrated non-inferior vision gains compared to aflibercept with a favorable safety profile. The drug will be available in the U.S. soon, with ongoing evaluations in Europe.

Roche announced that the FDA has granted priority review for a supplemental new drug application for Evrysdi (risdiplam) to treat pre-symptomatic babies under two months with spinal muscular atrophy (SMA). Interim data from the RAINBOWFISH study indicates that most treated babies achieved key developmental milestones, including the ability to sit, stand, and walk within typical timeframes for healthy infants. Evrysdi is already approved in 70 countries, with over 4,500 patients treated, and if approved, would be the first at-home treatment option for this age group.

Roche announced that The Lancet published results from four phase III studies of faricimab, targeting neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Over 3,000 participants were enrolled, achieving vision gains comparable to aflibercept while extending treatment intervals. Approximately 50% could go four months between doses, with 70-80% able to go three months or longer. Faricimab, the first bispecific antibody for eye conditions, is currently under FDA review, with positive findings supporting its potential as a significant treatment option.

Genentech announced promising results for faricimab, a bispecific antibody for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME), published in The Lancet. In Phase III trials involving over 3,000 participants, faricimab met primary endpoints, showing non-inferior vision gains compared to aflibercept while allowing treatment intervals of up to four months. Approximately 80% of patients achieved treatment every three months or longer. The FDA is reviewing faricimab for approval, marking it as a potential first-in-class therapeutic in ophthalmology.

Roche has launched the cobas® pulse system, a groundbreaking blood glucose management solution featuring mobile digital health capabilities. Designed for healthcare professionals, this device integrates advanced digital capabilities with a user-friendly interface. The system aims to streamline workflows, offering valuable clinical insights to enhance patient care. Roche's commitment to innovation is evidenced by partnerships with several digital health solution developers. The cobas® pulse system is currently available in select CE-marked countries, with plans for wider regulatory clearance in 2022.

Roche has introduced the cobas® infinity edge, a cloud-based platform designed to integrate patient test results, medical records, and third-party applications. This platform aims to enhance real-time monitoring and treatment adjustments across clinical settings. By breaking down data silos, it reduces costs and administrative burdens for healthcare providers. The platform is compliant with ISO27001, GDPR, and HIPAA regulations, ensuring security and privacy. Roche plans a global rollout throughout 2022 and 2023, enhancing digital health capabilities and patient care.

Roche has received Emergency Use Authorization (EUA) from the FDA for its COVID-19 At-Home Test, set to launch in January 2022. This rapid test allows individuals aged 14 and older to self-administer a nasal swab and obtain results within 20 minutes for SARS-CoV-2 and variants, including Omicron. Roche's collaboration with the NIH’s RADx initiative facilitated the rapid review process. The company plans to produce tens of millions of tests monthly to support the pandemic response, emphasizing the role of self-testing in public health. The test is the first rapid antigen test from Roche to receive EUA.