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.

Roche (RHHBY) gets Breakthrough Therapy Designation for gantenerumab for Alzheime's disease, which puts the spotlight on this challenging but promising space.

Roche's (RHHBY) AD Drug Gets Breakthrough Therapy Status

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer's disease (AD). This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a patholo

Genentech's Anti-Amyloid Beta Antibody Gantenerumab Granted FDA Breakthrough Therapy Designation in Alzheimer's Disease

Roche Holdings AG's (OTC: RHHBY) gantenerumab antibody received breakthrough therapy designation from the FDA for Alzheimer's disease. Gantenerumab is designed to neutralize beta-amyloid plaques seen as a driver behind brain cell death.

Roche's Alzheimer's Candidate Secures FDA Breakthrough Designation

Basel, 8 October 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer's disease (AD). This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of AD, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as other studies. Learnings from these studies have been incorporated into the optimised design of two ongoing parallel, global, placebo-controlled and randomised Phase III trials, GRADUATE 1 and 2. The pivotal trials are evaluating gantenerumab in more than 2,000 participants for more than two years and are expected to be completed in the second half of 2022.

[Ad hoc announcement pursuant to Art. 53 LR] Roche's anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer's disease

Ad hoc announcement pursuant to Art. 53 LR: Genentech's Anti-Amyloid Beta Antibody Gantenerumab Granted FDA Breakthrough Therapy Designation in Alzheimer's Disease

Basel, 5 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new OCREVUS® (ocrelizumab) and ENSPRYNG® (satralizumab) data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 13 - 15 October 2021. These data include 38 abstracts highlighting new longer-term efficacy and safety for both OCREVUS and ENSPRYNG, as well as our ongoing efforts to evaluate the impact of the COVID-19 pandemic for people living with MS. Additional data will show how a deeper scientific understanding of MS and NMOSD in diverse patient populations could help ensure access to treatment. “The longer-term efficacy and safety data for both OCREVUS and ENSPRYNG reinforce the impact of these treatments - by significantly slowing disease progression in MS and by preventing debilitating relapses in NMOSD, respectively,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We continue to see that early and ongoing treatment markedly improves outcomes, and we'll continue to use scientific and real-world insights to improve our understanding and ways to support people living with these neurological disorders.” Multiple sclerosis (MS) Roche will present 27 MS studies, including long-term data that show earlier treatment with OCREVUS continues to impact disability progression up to 8 years in people with primary progressive multiple sclerosis (PPMS) and up to 7.5 years in people with relapsing multiple sclerosis (RMS) in the Phase III open label extension studies. Additionally, updated long-term safety analysis of all clinical trials in patients with RMS and PPMS will reinforce the consistently favourable benefit-risk profile of OCREVUS. Roche remains committed to addressing health disparities and we believe inclusive research can improve outcomes and derive insights that may address treatment barriers. A subgroup analysis of three studies (SaROD, CHORDS ENSEMBLE PLUS) in Black, African-American, Hispanic and Latino populations treated with a 2-hour OCREVUS infusion will be presented. Neuromyelitis optica spectrum disorder (NMOSD) New longer-term results from the SAkuraStar and SAkuraSky OLE studies for ENSPRYNG will show efficacy observed in the pivotal trials is sustained with high proportions of patients remaining free from relapse over four years of treatment. Similarly, safety data from the SAkuraStar and SAkuraSky OLE studies will show the favourable safety profile of ENSPRYNG is sustained with longer-term treatment. ENSPRYNG has been approved in 58 countries globally, including in the U.S. as the first and only subcutaneous treatment for adults with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD. ENSPRYNG has also been approved for both adults and adolescents in the European Union, Japan, Canada and Switzerland. Roche is dedicated to increasing scientific understanding of NMOSD and improving care for all people living with the condition. The study design will be presented for SAkuraBONSAI, a prospective, open-label study of ENSPRYNG to generate data to further the understanding of the disease activity and mechanism of action of ENSPRYNG in patients living with AQP4-IgG seropositive NMOSD who are treatment naïve or where prior rituximab (or biosimilar) treatment has failed. Other presentations will examine the development of new tools and techniques to identify patients with NMOSD and assess disability better. Follow Roche on Twitter via @Roche and keep up to date with ECTRIMS 2021 news and updates by using the hashtag #ECTRIMS2021.

Roche to present new data on OCREVUS in multiple sclerosis and ENSPRYNG in neuromyelitis optica spectrum disorder at ECTRIMS 2021

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new Ocrevus® (ocrelizumab) and EnspryngTM (satralizumab-mwge) data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from October 13 – 15, 2021. These data include 38 abstracts highlighting new longer-term efficacy and safety for both Ocrevus and Enspryng, as well as our ongoing efforts t

Genentech to Present New Data on Ocrevus (ocrelizumab) in Multiple Sclerosis and Enspryng (satralizumab-mwge) in Neuromyelitis Optica Spectrum Disorder at ECTRIMS 2021

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Roche Holdings AG (OTC: RHHBY) announced positive data from Phase 2/3 2066 study of Ronapreve (casirivimab and imdevimab) or REGN-COV in hospitalized COVID-19 patients.  Related:   WHO Backs Regeneron COVID-19 Antibody Cocktail As It Calls For Equal Access.

Regeneron-Roche Post Encouraging New Data For COVID-19 Antibody Cocktail

Roche Holding AG said Thursday that its Phase 2/3 trial of Covid-19 treatment Ronapreve met its primary endpoint.

Roche says Phase 2/3 trial of COVID treatment Ronapreve met its primary endpoint

Basel, 30 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed positive data from the phase II/III 2066 study, investigating Ronapreve™ (casirivimab and imdevimab) in patients hospitalised with COVID-19. The trial met its primary endpoint, showing that Ronapreve significantly reduced viral load within seven days of treatment in patients who had not mounted a natural antibody response of their own (seronegative) and who required low-flow or no supplemental oxygen (p=0.0172). Full results of the study will be presented at ID Week 2021 today.

Phase II/III trial shows Ronapreve™ (casirivimab and imdevimab) significantly reduces viral load within seven days of treatment in patients hospitalised with COVID-19

Roche Holding AG (OTC: RHHBY) has highlighted new data for its oral spinal muscular atrophy (SMA) treatment Evrysdi, showing its benefits when given to pre-symptomatic babies with the rare disease. The data were presented at the World Muscle Society (WMS) Virtual Congress.

Roche Builds Case For Evrysdi Benefits In Younger Spinal Muscular Atrophy Patients

Basel, 24 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from across its growing neuromuscular portfolio at the World Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. The presentations included additional results from the RAINBOWFISH study, evaluating the efficacy and safety of Evrysdi® (risdiplam) in babies with pre-symptomatic spinal muscular atrophy (SMA) from birth to six weeks of age and data supporting the continued clinical investigation of gene therapy, SRP-9001, in Duchenne muscular dystrophy (DMD). “These new data for Evrysdi may help extend the potential benefits of this medicine to the youngest SMA patients. Also, the data from SRP-9001 have helped to optimise the design of the upcoming Phase III trial for DMD,” said Levi Garraway, M.D., Ph.D, Roche's Chief Medical Officer and Head of Global Product Development. “Our goal is to continue to lead the way in developing transformative medicines for neuromuscular diseases. We are grateful for the partnerships that are helping us to develop new therapies for people impacted by these devastating rare diseases.” At WMS 2021, data from the ongoing open label RAINBOWFISH study were presented. Four out of five of those treated with Evrysdi for at least 12 months achieved standing and walking independently within the World Health Organization windows for healthy children. In addition, all five babies maintained the ability to swallow and were able to feed exclusively orally after 12 months of treatment. Previously reported results showed that babies treated with Evrysdi for at least 12 months achieved Hammersmith Infant Neurological Examination (HINE-2) motor milestones, with 100% (n=5) able to maintain head control, sitting upright, rolling and crawling. These data further add to the growing body of evidence supporting Evrysdi's efficacy in a broad patient population. More than 4,000 patients have been treated with Evrysdi in clinical trials, compassionate use, and real-world settings. In DMD, three-year data from the open-label trial, Study SRP-9001-101, evaluating the safety of a single dose of the investigational gene therapy SRP-9001 in four ambulatory children aged 4 and 7 years old with DMD, were presented. The study showed that SRP-9001 was well-tolerated with key functional assessment, measured by the North Star Ambulatory Assessment (NSAA), demonstrating an overall improvement in motor ability compared to baseline. The improvements in motor abilities were maintained over three years, signifying a durable response. The results support the continuation of clinical investigation to further assess the benefit/risk of SRP-9001 in patients with DMD. Roche, and partner Sarepta, also shared data from ENDEAVOR (Study SRP-9001-103), the first clinical trial using commercially representative SRP-9001 material for the treatment of DMD. Interim results from the first 11 participants in Cohort 1 (ambulatory boys aged 4-7 years) from the open label, ongoing Phase 1b study, provides evidence that SRP-9001 showed robust expression of micro-dystrophin and no new safety signals were identified. In addition, results from Part 1 of Study SRP-9001-102, an ongoing, randomised, double-blind, placebo-controlled clinical trial evaluating the safety, efficacy, and tolerability of a single dose of SRP-9001 in 41 boys with DMD, showed that the study met its primary biological endpoint of change in micro-dystrophin protein expression from baseline. Participants treated with SRP-9001, generally showed an increase in NSAA total score compared to placebo at 48 weeks, although this increase did not achieve statistical significance compared to that of patients who received placebo. The safety profile was consistent with prior studies, with no new safety signals identified. The results of these studies provide important information for SRP-9001's ongoing clinical development programme, with outcomes from Study 101 and 102 informing the design of the Phase 3 trial for SRP-9001, due to commence globally by the end of the year. About Evrysdi ® ( risdiplam ) Evrysdi is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat SMA by increasing production of the survival of motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older. Evrysdi was granted PRIME designation by the EMA in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. At this time, Evrysdi has been approved in over 50 countries including the US and Europe and submitted in more than 30 countries. About SMA SMA is a severe, progressive neuromuscular disease that can be fatal. It affects approximately one in 10,000 babies and is the leading genetic cause of infant mortality. SMA is caused by a mutation of the survival motor neuron 1 (SMN1) gene, which leads to a deficiency of SMN protein. This protein is found throughout the body and is essential to the function of nerves that control muscles and movement. Without it, nerve cells cannot function correctly, leading to muscle weakness over time. Depending on the type of SMA, an individual's physical strength and their ability to walk, eat or breathe can be significantly diminished or lost. About SRP-9001 SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) is an investigational gene therapy designed to deliver the micro-dystrophin-encoding gene directly to the skeletal and cardiac muscle for the targeted production of the micro-dystrophin protein to enable a durable clinical response. Sarepta Therapeutics is responsible for global development and manufacturing for SRP-9001 and plans to commercialize SRP-9001 in the United States upon receiving FDA approval. In December 2019, Roche partnered with Sarepta to combine Roche's global reach, commercial presence, and regulatory expertise to accelerate access to SRP-9001 for patients outside the United States. About DMD DMD is a rare X-linked, progressive neuromuscular disease caused by mutations in the DMD gene that disrupts the production of functional dystrophin protein, leading to a loss of muscle function and premature death. DMD is one of the most common fatal genetic disorders, affecting approximately one in every 3,500 to 5,000 male births worldwide. Symptoms usually appear in infants and toddlers, with affected children presenting developmental delays such as difficulty walking, climbing stairs or standing from a sitting position. As DMD progresses, muscle weakness involves the arms, trunk, and other areas, meaning patients often require full-time use of a wheelchair in their early teens. Longevity is limited due to cardiac and/or respiratory failure. About Roche in Neuroscience Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche presents new data at World Muscle Society (WMS) 2021 highlighting new advances for people living with rare neuromuscular disorders

Basel, 22 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of three molecular PCR diagnostic test panels to simultaneously detect and differentiate common respiratory pathogens:

Roche launches three respiratory test panels on cobas 6800/8800 Systems in CE markets to help identify multiple pathogens with overlapping symptoms in patients

Roche (RHHBY) gets a positive CHMP opinion for Gavreto for the treatment of adult patients with RET fusion-positive advanced NSCLC.

Roche (RHHBY) Lung Cancer Drug Gets Positive CHMP Opinion

Basel, 20 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today presented new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq® (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%. Data from the IMpower010 trial were published simultaneously in The Lancet. In IMpower010, treatment with Tecentriq, following surgery and chemotherapy, reduced the risk of disease recurrence or death (DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50–0.88) in people with Stage II-IIIA NSCLC whose tumours express PD-L1≥1%, compared with best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.

New Phase III data support the benefit of Roche's Tecentriq in early-stage lung cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today presented new data from the Phase III IMpower010 study at the European Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the significant disease-free survival (DFS) benefit offered by Tecentriq® (atezolizumab) for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%. Data from the IMpower010 trial were

New Phase III Data Support the Benefit of Genentech's Tecentriq in Early-stage Lung Cancer

Basel, 17 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gavreto® (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

Roche receives positive CHMP opinion for Gavreto® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

The ardor for shares of AC Immune SA ( ACIU , Financial) has cooled considerably since the company's Aug. 31 announcement of somewhat promising study results for its Alzheimer's drug. The Swiss biotech's stock shot up to a 52-week high of $12.61, but has since been halved as investors questioned how meaningful the trial results were.

Alzheimer's Drug for Roche Partner AC Immune Shows Promise

Basel, 15 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the introduction of the Roche Digital Pathology Open Environment that allows software developers to easily integrate their image analysis tools for tumour tissue with Roche's uPath enterprise software, an application for pathologist workflow. This open environment allows for the secure exchange and flow of data so that pathologists can access advanced algorithms from third parties alongside Roche's menu of artificial intelligence-based image analysis tools. This enables software developers globally to distribute their digital products through Roche's uPath software, offering a broader set of diagnostic tools for pathologists and ultimately the potential for better and faster answers for patients.

Roche opens access to pathology imaging tools to improve patient care

The stock price of Roche Holding's ADR reached its all-time high of $51 in August, before a recent sell-off in the stock, which led to a 3% drop in its price in five trading days to levels of $47 currently.

Will Roche Stock Rebound After A 7% Fall In A Week?

Novocure

Novocure Ltd (NASDAQ: NVCR) has entered into a clinical trial collaboration agreement with Roche Holdings AG (OTC: RHHBY) to develop Tumor Treating Fields (TTFields) together with Roche's atezolizumab in metastatic pancreatic ductal adenocarcinoma (mPDAC). The phase 2 study was designed to test the safety and efficacy of TTFields together with atezolizumab, gemcitabine, and nab-paclitaxel as a first-line treatment for mPDAC.

Novocure To Test Its Tumor Treating Fields With Roche's Tecentriq In Pancreatic Cancer

Roche Holdings AG (OTC: RHHBY) has agreed to acquire  TIB Molbiol Group for an undisclosed amount. The deal is expected to close in Q4 of 2021.

Roche Beefs Up PCR-Test Portfolio With TIB Molbiol Acquisition

Basel, 09 September 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has signed a definitive share purchase agreement to acquire 100% of the outstanding shares of the TIB Molbiol Group. Closing of the transaction is subject to customary conditions and is expected in the fourth quarter of 2021.

Roche signs definitive share purchase agreement with long-term partner TIB Molbiol to expand PCR-test portfolio in the fight against new infectious diseases

Adaptimmune Therapeutics

Adaptimmune (ADAP) shares jump on a collaboration and license agreement with Roche for the development of allogeneic T-cell therapies for up to five shared cancer targets.

Adaptimmune (ADAP) Gains on Deal With Roche for Cell Therapies

AstraZeneca

Johnson & Johnson

Pfizer

Most Large Cap Pharmaceuticals industry players' Q2 results were strong. Regulatory/pipeline updates related to COVID-19 medicines/vaccines continue to take center stage.

News for Roche Holding AG Stock (RHHBY)