Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

PLEASANTON, Calif., Feb. 23, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the expansion of the COVID-19 PCR portfolio to the cobasⓇ 5800 System, a recently launched molecular laboratory instrument, in countries accepting the CE mark.

Roche expands the COVID-19 PCR test portfolio to the new cobas 5800 System in countries accepting the CE Mark

Roche's 2H/Q4'21 earnings didn't help already-soft sentiment, as Roche posted some notable margin misses on weaker gross margins tied in part to COVID-19.

Roche Knocked Back A Bit Ahead Of A Year Of Important Read-Outs

Analog Devices

Analog Devices, Inc. (ADI) CEO Vincent Roche on Q1 2022 Results - Earnings Call Transcript

Basel, 11 February 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Actemra®/RoActemra® (tocilizumab) intravenous (IV) has been granted World Health Organization (WHO) prequalification. Prequalification is a confirmation by WHO that Actemra/RoActemra meets the WHO standards for quality, safety and efficacy for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.1 It helps procurers in low- and middle-income countries identify priority medicines to improve access to care and support better health.

WHO grants prequalification of Actemra/RoActemra for patients with severe or critical COVID-19

Basel, 11 February 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new two-year data from its phase III studies of Vabysmo™ (faricimab) and Susvimo™ (previously called Port Delivery System with ranibizumab) will be presented at Angiogenesis, Exudation and Degeneration 2022 on 12 February. These longer-term results from the Vabysmo YOSEMITE and RHINE studies in diabetic macular edema (DME) and the Susvimo Archway study in neovascular or “wet” age-related macular degeneration (nAMD) further reinforce the potential to allow for longer time between treatments and fewer eye injections for people with these conditions, while still achieving and maintaining vision gains seen with previous standard-of-care injections. Neovascular AMD and DME are two leading causes of vision loss, together affecting around 40 million people worldwide, which require treatment with eye injections as often as once a month.1-4

New two-year data for Roche's Vabysmo and Susvimo reinforce potential to maintain vision with fewer treatments for people with two leading causes of vision loss

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new two-year data from its Phase III studies of Vabysmo™ (faricimab-svoa) and Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant will be presented at Angiogenesis, Exudation and Degeneration 2022 on Feb. 12. These longer-term results from the Vabysmo YOSEMITE and RHINE studies in diabetic macular edema (DME) and the Susvimo Archw

New Two-Year Data for Genentech's Vabysmo and Susvimo Reinforce Potential to Maintain Vision With Fewer Treatments for People With Two Leading Causes of Vision Loss

Hanover Insurance Group

Hanover Insurance Group, Inc. (THG) CEO John Roche on Q4 2021 Results - Earnings Call Transcript

Roche Holding's (RHHBY) CEO Severin Schwan on Full Year Results 2021 Results - Earnings Call Transcript

Roche (RHHBY) performance in the fourth quarter and 2021 was encouraging, driven by demand for COVID-19 tests and recovery in pharma sales. However, sales are expected to slow down in 2022.

Roche's (RHHBY) 2021 Earnings, Sales Grow on COVID-19 Tests

Roche Holdings AG's RHHBY FY21 sales increased 8% Y/Y (9% on a constant currency basis) to CHF 62.8 billion. Thousands of new traders are learning the ins and outs on how to find profitable trades every day with Benzinga Trading School.

Roche Expects Slower FY22 Sales Growth On Lower Demand For COVID-19 Tests

Swiss drugmaker Roche said sales growth would slow this year as it braces for less demand for its COVID-19 medicines and diagnostics.

Roche sees slower 2022 sales growth as COVID-19 test demand eases

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results in 2021

Veteran strategist David Roche warns the recent volatility could be pointing toward a bear market, rather than a temporary speed bump in a continued bull run.

Veteran strategist David Roche warns markets could be at a 'turning point' toward a bear market

Changes to the Roche Board of Directors and the Corporate Executive Committee

Roche Holding AG (RHHBY) has been upgraded to a Zacks Rank #1 (Strong Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

All You Need to Know About Roche Holding AG (RHHBY) Rating Upgrade to Strong Buy

Basel, 31 January 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Vabysmo™ (faricimab-svoa) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). Neovascular AMD and DME are two leading causes of vision loss worldwide.1 Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).2 Vabysmo is the first and only FDA-approved injectable eye medicine for nAMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses, based on evaluation of the patient's anatomy and vision outcomes.3 Standard of care for nAMD and DME typically requires eye injections every one to two months.2,4

FDA approves Roche's Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Vabysmo™ (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Wet AMD and DME are two leading causes of vision loss among U.S. adults. Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening r

FDA Approves Genentech's Vabysmo, the First Bispecific Antibody for the Eye, to Treat Two Leading Causes of Vision Loss

The FDA has granted priority review for Genentech's, a unit of Roche Holdings AG (OTC: RHHBY) supplemental marketing application for Evrysdi (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA).  Evrysdi is already approved to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older.

Genentech's Evrysdi Application Under FDA Priority Review For Use In Babies Below 2 Months

Roche Holding AG (RHHBY) witnesses a hammer chart pattern, indicating support found by the stock after losing some value lately. This coupled with an upward trend in earnings estimate revisions could mean a trend reversal for the stock in the near term.

Here's Why Roche Holding AG (RHHBY) Could be Great Choice for a Bottom Fisher

Basel, 25 January 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of a supplemental new drug application (sNDA) for the use of Evrysdi® (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA). The sNDA submission incorporates interim data from the RAINBOWFISH study, which shows the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting, standing, walking and maintained the ability to swallow following 12 months of treatment.  “Treating very young babies with Evrysdi before SMA symptoms arise may help them to achieve milestones such as standing and walking within timeframes typical of healthy infants,” said Levi Garraway, M.D., Ph. D., Roche's Chief Medical Officer and Head of Global Product Development. “Extending treatment access for the youngest members of the SMA community is crucial and we look forward to working with the FDA on this application.” Evrysdi is designed to treat SMA by increasing and sustaining production of the survival motor neuron (SMN) protein in the central nervous system (CNS) and peripheral tissues. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Evrysdi's existing FDA label is for the treatment of SMA in adults, children and babies two months and older. If approved, Evrysdi would be the first medicine administered at-home for pre-symptomatic babies with SMA.  Initial interim data from the RAINBOWFISH study, presented at the World Muscle Society (WMS) Virtual Congress 2021, showed that of the babies included in the interim efficacy analysis, all (5/5), maintained the ability to swallow and were able to feed exclusively orally after 12 months of treatment. Eighty per cent (4/5) treated with Evrysdi for at least 12 months achieved milestones such as standing and walking independently within World Health Organization windows for healthy children. All participants (n=5) met HINE-2* motor milestones of head control, sitting upright, rolling and crawling after 12 months of treatment with Evrysdi.  No treatment related serious adverse events were reported in any of the babies treated with Evrysdi through the interim safety analysis period (n=12). Four treatment emergent adverse events were reported, and all were resolved or were resolving with ongoing treatment with Evrysdi. The most common adverse events (AEs) were nasal congestion (33%), cough (25%), teething (25%), vomiting (25%), eczema (17%), abdominal pain (17%), diarrhoea (17%), gastroenteritis (17%), papule (17%) and pyrexia (17%). The AEs were reflective of the age of the babies rather than the underlying SMA. The RAINBOWFISH study is currently recruiting. The latest results from the RAINBOWFISH study will be presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference in March 2022.  Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. *Hammersmith Infant Neurological Examination, Section 2 About Evrysdi ® ( risdiplam ) Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.  Evrysdi is designed to treat SMA by increasing and sustaining the production of the survival motor neuron (SMN) protein in the central nervous system (CNS) and peripheral tissues. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.  Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S Food and Drug Administration in 2017. In 2021 Evrysdi was awarded Drug Discovery of the Year by the British Pharmacological Society as well as the Society for Medicines Research award for Drug Discovery. Evrysdi is currently approved in 70 countries and the dossier is under review in a further 31 countries.  Evrysdi is currently being evaluated in five multicentre trials in people with SMA:

Roche's Evrysdi (risdiplam) granted FDA priority review for treatment of pre-symptomatic babies under 2 months of age with spinal muscular atrophy (SMA)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of a supplemental new drug application (sNDA) for the use of Evrysdi® (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA). The sNDA submission incorporates interim data from the RAINBOWFISH study, which shows the majority of pre-symptomatic

Genentech's Evrysdi (risdiplam) Granted FDA Priority Review for Treatment of Pre-Symptomatic Babies Under 2 Months of Age With Spinal Muscular Atrophy (SMA)

Basel, 24 January 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that The Lancet has published two papers highlighting one-year results from four pivotal phase III studies of faricimab, an investigational bispecific antibody, in neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). [1,2] All four studies – which enrolled more than 3,000 people in total – met their primary endpoints, showing that people treated with faricimab up to every four months achieved non-inferior vision gains compared to aflibercept given every two months. Notably, about half of eligible faricimab patients were able to go four months between treatments in the first year, and approximately three-quarters could go three months or longer in the TENAYA and LUCERNE nAMD studies and the YOSEMITE and RHINE DME studies. [1,2] The current standard of care for these potentially blinding conditions requires eye injections as often as once a month [3,4]. “These data published in The Lancet reinforce the potential of faricimab as an important treatment option that may help improve and maintain vision while extending the time between treatments up to four months,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We remain deeply committed to developing new medicines such as faricimab that may help preserve sight in many people living with serious retinal conditions.” If approved, faricimab would be the first bispecific antibody for the eye, targeting and inhibiting two distinct pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). [5] Inhibition of both pathways has been shown to have potentially complementary benefits, stabilising vessels and thereby reducing vessel leakage and inflammation more than inhibition of the VEGF-A pathway alone. [6] Key Findings [1,2]In the TENAYA and LUCERNE studies in nAMD, the average vision gains from baseline at one-year in the faricimab arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms. The studies also measured the proportion of people in the faricimab arm that were treated on dosing schedules of every three or four months during the first year. Importantly, 46% (n=144/315) of patients in TENAYA and 45% (n=142/316) in LUCERNE were able to be treated every four months in the first year. An additional 34% (n=107/315) of patients in TENAYA and 33% (n=104/316) in LUCERNE were able to be treated every three months. Combined, nearly 80% of faricimab-treated patients were able to go three months or longer between treatments during the first year. Consistent with vision outcomes, faricimab treatment resulted in a meaningful and comparable reduction in central subfield thickness (CST) and comparable decreases in choroidal neovascularisation lesion size and area. Faricimab was generally well-tolerated in both studies, with a favourable benefit-risk profile. Ocular adverse events (AEs) were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with nAMD. In the YOSEMITE and RHINE studies in DME, the average vision gains from baseline at one-year were +11.6 and +10.8 eye chart letters in the faricimab treat-and-extend arms, +10.7 and +11.8 letters in the two-month arms and +10.9 and +10.3 letters in the aflibercept arms, respectively. A secondary endpoint in both studies measured the proportion of people in the faricimab treat-and-extend arms that achieved dosing schedules of every three or four months at the end of the first year. Importantly, 53% (n=151/286) of faricimab treat-and-extend patients in YOSEMITE and 51% (n=157/308) in RHINE achieved four-month dosing at one-year. An additional 21% (n=60/286) of faricimab treat-and-extend patients in YOSEMITE and 20% (n=62/308) in RHINE achieved three-month dosing. Combined, more than 70% of faricimab treat-and-extend patients were able to go three months or longer between treatments at the end of the first year. Reductions in CST and resolution of intraretinal fluid through the first year consistently favoured faricimab over aflibercept. Faricimab was generally well-tolerated in both studies, with a favourable benefit-risk profile. Ocular AEs were comparable across treatment arms and consistent with those expected with intravitreal anti-VEGF injections in patients with DME. Faricimab is currently under review by the U.S. Food and Drug Administration for the treatment of nAMD and DME. The European Medicines Agency is also currently evaluating the faricimab Marketing Authorisation Application for the treatment of nAMD and DME. Additionally, the COMINO and BALATON trials are underway, evaluating the efficacy and safety of faricimab in people with macular edema following retinal vein occlusion. [7,8] Two-year results for faricimab in DME will be presented at the Angiogenesis, Exudation, and Degeneration 2022 meeting, on Saturday 12 February. About the TENAYA and LUCERNE studies [1]TENAYA (NCT03823287) and LUCERNE (NCT03823300) are two identical, randomised, multicentre, double-masked, global phase III studies, evaluating the efficacy and safety of faricimab compared to aflibercept in 1,329 people living with neovascular or “wet” age-related macular degeneration (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: faricimab 6.0 mg administered at fixed intervals of every two, three, or four months, selected based on objective assessment of disease activity at weeks 20 and 24; aflibercept 2.0 mg administered at fixed two-month intervals. In both arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants. The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline averaged over weeks 40, 44 and 48. Secondary endpoints include: safety; the percentage of participants in the faricimab arm receiving treatment every two, three and four months; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; change in central subfield thickness from baseline over time; and change in total area of choroidal neovascularization lesion and leakage from baseline over time. About the YOSEMITE and RHINE studies [2]YOSEMITE (NCT03622580) and RHINE (NCT03622593) are two identical, randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of faricimab compared to aflibercept in 1,891 people with diabetic macular edema (940 in YOSEMITE and 951 in RHINE). The studies each have three treatment arms: faricimab 6.0 mg administered at intervals of up to every four months using a treat and extend approach, after four initial monthly doses; faricimab 6.0 mg administered at fixed two-month intervals after six initial monthly doses; and aflibercept administered at fixed two-month intervals after five initial monthly doses. In all three arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants. The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score from baseline at one-year. Secondary endpoints include: safety; the percentage of participants in the treat and extend arm receiving faricimab every one, two, three and four months, at week 52; the percentage of participants achieving a two-step or greater improvement from baseline in diabetic retinopathy severity at week 52; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; change in central subfield thickness from baseline over time; and percentage of patients with absence of intraretinal fluid over time. About neovascular age-related macular degeneration Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. [9,10] Neovascular or “wet” AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss. [11,12] It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis. [12] Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages. [9,13,14] About diabetic macular edema Affecting around 21 million people globally, diabetic macular edema (DME) is a vision-threatening complication of diabetic retinopathy (DR). [15] DME occurs when the damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. [10,16] The number of people with DME is expected to grow as the prevalence of diabetes increases. [17] The condition is associated with blindness when left untreated and decreased quality of life. [18] There remains a significant unmet need for more effective, longer-lasting therapies for people with DME. [6] About faricimab [5]Faricimab is the first investigational bispecific antibody designed for the eye. It targets two distinct pathways linked to a number of vision threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking both pathways involving Ang-2 and VEGF-A, faricimab is designed to stabilise blood vessels, potentially improving vision outcomes for longer for people living with retinal conditions. About Roche in Ophthalmology Roche is focused on saving people's eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

The Lancet publishes studies showing Roche's faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced The Lancet has published two papers highlighting one-year results from four pivotal Phase III studies of faricimab, an investigational bispecific antibody, in wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). All four studies – which enrolled more than 3,000 people in total – met their primary endpoints, showing that patie

The Lancet Publishes Studies Showing Genentech's Faricimab Improved and Maintained Vision in Two Leading Causes of Vision Loss, Extending Time Between Treatments up to Four Months

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