Roche Hldg - RHHBY STOCK NEWS

Roche announced that its drug Actemra®/RoActemra® received prequalification from the World Health Organization (WHO), confirming its standards for treating severe COVID-19. Over one million patients have been treated globally, as per guidelines. This marks Roche's twelfth medicine or test to achieve such prequalification. The company aims to enhance access to Actemra/RoActemra for low- and middle-income countries, collaborating with WHO to provide the drug at cost and ensuring legal certainty for manufacturers. Roche has also enabled over 1.2 billion COVID-19 tests since the pandemic began.

Roche announced new two-year data from phase III studies of Vabysmo and Susvimo, showing significant advancements in treatment for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). In the YOSEMITE and RHINE studies, at least 60% of eligible patients could extend Vabysmo treatments to every four months, up from 50% at year one. Nearly 80% could extend to three months or longer. The Archway study revealed that 95% of Susvimo patients maintained a six-month treatment schedule. Both therapies demonstrate improved vision outcomes and favorable safety profiles.

Roche reported a 9% increase in Group sales for 2021, reaching CHF 62.8 billion, driven by strong demand for newly launched medicines and diagnostics. The Pharmaceuticals Division saw a 3% sales growth, while the Diagnostics Division grew by 29%, largely due to COVID-19 tests. Key approvals included Susvimo and Vabysmo in the U.S. For 2022, Roche expects stable or low-single-digit sales growth, anticipating a decline in COVID-19 medicine sales by CHF 2 billion. Core EPS rose 6%, and the board proposed an increase in dividends to CHF 9.30.

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.