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.

Basel, 22 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval under conditional marketing authorisation for mosunetuzumab for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), who have received at least two prior systemic therapies. Based on this positive CHMP opinion, a final decision regarding the conditional approval of mosunetuzumab is expected from the European Commission in the near future. Follicular lymphoma is the second most common form of lymphoma globally, accounting for 20% of all non-Hodgkin lymphomas (NHL) diagnosed worldwide.[1] “The majority of people with follicular lymphoma experience frequent relapses, and with each successive therapy the duration of remission and survival shortens,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Today's decision acknowledges the potential of mosunetuzumab as an efficacious, readily available, fixed-duration option, and brings the possibility of new hope to people living with this disease.” More than 28,000 people in Europe are diagnosed with FL each year.[1,2] The majority of people with FL relapse within five years after initial treatment, and for those who have received two or more prior therapies, conventional treatment options are currently limited and are associated with low rates of complete and durable remissions.[3,4] If approved, mosunetuzumab will be a first-in-class CD20xCD3 T-cell engaging bispecific antibody in NHL. The CHMP recommendation is based on positive results from the phase I/II GO29781 study where mosunetuzumab showed high complete response (CR) rates, with the majority of complete responders maintaining responses for at least 18 months, and favourable tolerability in people with heavily pretreated FL. After a median follow-up of 18.3 months, the CR rate was 60% (n=54/90), the objective response rate was 80% (n=72/90), and median progression-free survival was 17.9 months (95% CI: 10.1-not estimable). The median duration of response among those who responded was 22.8 months (95% CI: 9.7-not estimable). The most common adverse event was cytokine release syndrome (44.4%) which was generally low grade (grade 1: 25.6%; grade 2: 16.7%), and resolved by end of treatment. Treatment was administered without mandatory hospitalisation. Results were presented for the first time in December 2021 at the 63rd American Society of Hematology Annual Meeting & Exposition. [5] In June 2020, mosunetuzumab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of adult patients with FL who have received at least two prior systemic therapies. A robust development programme for mosunetuzumab is ongoing including two phase III studies: CELESTIMO investigating mosunetuzumab plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating mosunetuzumab plus Polivy® (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma (DLBCL). This recommendation is Roche's second CHMP positive opinion in NHL in 2022, following the positive opinion for Polivy in combination with MabThera® (rituximab) plus cyclophosphamide, doxorubicin and prednisone in previously untreated DLBCL.[6] With our broad portfolio and pipeline, we are committed to providing treatment solutions for different stages of blood disorders, that are tailored to the disease, patient, physician, and healthcare system, as monotherapies or in combination with established and/or novel agents. About mosunetuzumab Mosunetuzumab is an investigational CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient's existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for mosunetuzumab is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers. About the GO29781 study The GO29781 study [NCT02500407] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include complete response rate (best response) by independent review facility (primary endpoint), objective response rate, duration of response, progression-free survival, safety and tolerability (secondary endpoints). About follicular lymphoma Follicular lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL.[1] It is considered incurable and relapse is common. It is estimated that more than 100,000 people are diagnosed with FL each year worldwide, including over 28,000 people in Europe.[1,2] About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera® (rituximab), Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

CHMP recommends EU conditional approval of Roche's potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma

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Roche (RHHBY) sBLA is seeking approval for the intravenous formulation of arthritis drug Actemra accepted and granted Priority Review in the United States.

Roche (RHHBY) Actemra Application Receives Priority Review

New diagnostics solutions will be presented that help clinicians improve patient care and support healthcare systems. Participants can join virtually or onsite to learn about timely healthcare topics related to value-based healthcare, digital health and diagnostic technologies.

Roche to showcase the future of diagnostic solutions at EuroMedLab, 10 to 14 April 2022 Munich at ICM International Congress Center

Basel, 04 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra®/RoActemra® (tocilizumab) intravenous for the treatment of COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. A decision on U.S. FDA approval is expected in the second half of this year.

U.S. FDA grants priority review to Roche's Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults

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 accepted the company's supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical v

U.S. FDA Grants Priority Review to Genentech's Actemra for the Treatment of COVID-19 in Hospitalized Adults

Basel, 04 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new OCREVUS® (ocrelizumab) data that show its benefit on disease progression and cognitive outcomes in primary progressive multiple sclerosis (PPMS) and secondary progressive MS (SPMS). Separate analyses on treatment disparities among newly diagnosed patients with MS by race and ethnicity will be a platform presentation at the 74th American Academy of Neurology (AAN) Annual Meeting 02–07 April 2022 in Seattle. CONSONANCE data will be presented virtually at AAN 24-26 April 2022.

New data for Roche's OCREVUS (ocrelizumab) show benefit in disability progression and cognitive decline in both secondary progressive and primary progressive multiple sclerosis

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new Ocrevus® (ocrelizumab) data that show its benefit on disease progression and cognitive outcomes in primary progressive multiple sclerosis (PPMS) and secondary progressive MS (SPMS). Separate analyses on treatment disparities among newly diagnosed patients with MS by race and ethnicity will be a platform presentation at the 74th American Academy of Neurology (AAN

New Data for Genentech's Ocrevus (ocrelizumab) Show Benefit in Disability Progression and Cognitive Decline in Both Secondary Progressive and Primary Progressive Multiple Sclerosis

Roche (RHHBY) phase III SKYSCRAPER-02 study assessing tiragolumab plus Tecentriq and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer did not meet co-primary endpoint of progression-free survival.

Roche (RHHBY) Late-Stage Study for ES-SCLC Fails to Meet Goal

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial (first-line) treatment for people with extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival. The co-primary

Genentech Provides Update on Phase III SKYSCRAPER-02 Study in Extensive-Stage Small Cell Lung Cancer

Ad hoc announcement pursuant to Art. 53 LR

Ad hoc announcement pursuant to Art. 53 LR Roche provides update on phase III SKYSCRAPER-02 study in extensive-stage small cell lung cancer

Roche is "losing money in Russia", Chief Executive Severin Schwan said in an interview published on Tuesday, but remains committed to providing medication to patients there.

Roche loses money in Russia, chief executive says

Basel, 25 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Polivy® (polatuzumab vedotin) in combination with MabThera® (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL). Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in this disease in more than 20 years. A final decision regarding the approval of this Polivy combination is expected from the European Commission in the near future. DLBCL is the most common form of non-Hodgkin lymphoma and it is estimated 40,000 people in Europe are diagnosed with the disease each year.[3,4] Approximately four out of ten patients will relapse after first line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes.[1,2] “A significant proportion of people newly diagnosed with diffuse large B-cell lymphoma, an aggressive form of blood cancer, do not respond adequately to existing therapies,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Therefore, more treatment options are needed that could increase a person's chance of cure, and we look forward to bringing this new Polivy combination to people with DLBCL as soon as possible.” The CHMP opinion was based on efficacy and safety data from the phase III POLARIX study (GO39942), comparing Polivy in combination with chemotherapy regimen R-CHP versus the standard of care MabThera plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in treatment of first-line DLBCL. The study showed significantly higher progression-free survival (PFS) versus R-CHOP after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; P

CHMP recommends EU approval of Roche's Polivy combination for people with previously untreated diffuse large B-cell lymphoma

Basel, 25 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data for its approved and investigational medicines across neurological disorders will be presented at the 74th American Academy of Neurology (AAN) Annual Meeting being held 02-07 April in Seattle and virtually 24-26 April 2022. These data include twenty-four abstracts highlighting Roche's expansive neuroscience portfolio across five therapeutic areas, including OCREVUS® (ocrelizumab) in relapsing, secondary and primary progressive multiple sclerosis (RMS, SPMS and PPMS), EVRYDSI™ (risdiplam) in spinal muscular atrophy (SMA), ENSPRYNG™ (satralizumab) in neuromyelitis optica spectrum disorder (NMOSD), along with data from investigational programs in Alzheimer's disease (AD) and Duchenne muscular dystrophy (DMD).

Roche to present data across broad and impactful neuroscience portfolio at 2022 AAN Annual Meeting

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data for its approved and investigational medicines across neurological disorders will be presented at the 74th American Academy of Neurology (AAN) Annual Meeting being held April 2-7 in Seattle and virtually April 24-26, 2022. These data include twenty two abstracts highlighting Genentech's expansive neuroscience portfolio across multiple therapeutic areas, inc

Genentech to Present Data Across Broad and Impactful Neuroscience Portfolio at 2022 AAN Annual Meeting

Collaboration builds on commitment to advance personalised healthcare by helping to improve access to new treatment options for patients with solid tumours Advances in computation and artificial intelligence (AI) in digital pathology are showing promise to meet the demand for more accurate and comprehensive assessment of pathology results to enable improved patient outcomes Leverages Roche's Digital Pathology Open Environment and the collaboration with PathAI, bringing innovative technology faster to clinical trial settings and anatomic pathology laboratories TUCSON, Ariz. , March 25, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has entered into a collaboration with Bristol Myers Squibb to support the advancement of two assays for use in clinical trials with the development and deployment of two new digital pathology algorithms.

Roche announces collaboration with Bristol Myers Squibb to advance personalised healthcare through digital pathology solutions

The stock price of Roche's ADR has seen a fall of 7% year-to-date, while it's up 3.5% in a month. Roche's revenue grew 13% y-o-y to $72.4 billion in 2021, aided by Covid-19 diagnostics tests and Ronapreve - a treatment for Covid-19, developed by Regeneron and distributed by Roche outside the U.S..

Roche Stock Has More Upside

Basel, 16 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and TIB Molbiol, a subsidiary within the Roche Diagnostics division, today announced available testing solutions that can identify the SARS-CoV-2 B.1.1.529 variant and differentiate between the Omicron subvariants BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and Delta.

Roche provides molecular testing solutions to identify and differentiate SARS-CoV-2 Omicron variants of concern

Basel, 16 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data for Evrysdi® (risdiplam) in spinal muscular atrophy (SMA). Presentations included new three-year data from the SUNFISH study which further confirmed the long-term efficacy and safety of Evrysdi in a broad population of people aged 2-25 years with Type 2 or Type 3 SMA. Additional presentations included exploratory two-year efficacy data from SUNFISH Part 2, demonstrating improvement in or stabilisation of motor function with Evrysdi compared to an untreated external control group. Roche also announced updated interim data from the RAINBOWFISH study in pre-symptomatic babies with SMA under two months of age. The data were presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, March 13-16, 2022. “The positive long-term efficacy and safety results for Evrysdi in this broad SMA population are important for physicians as they consider Evrysdi as a treatment option for their patients,” said Laurent Servais, M.D., Ph.D., Professor of Paediatric Neuromuscular Diseases at the MDUK Oxford Neuromuscular Centre. “In treating people with SMA, our aim is to enable or preserve their independence and patients in the SUNFISH study reported continuous improvement or stabilisation in the level of help needed for daily living.” In the SUNFISH study, the increase in Motor Function Measure 32 (MFM32) total score from baseline previously observed at year one was maintained through year three in people treated with Evrysdi. The increases in Revised Upper Limb Module (RULM) and Hammersmith Functional Motor Scale Expanded (HFMSE) total scores from baseline were also sustained between year one and year three. Evrysdi was well-tolerated over the three-year time period in the SUNFISH study. The overall rate of adverse events (AEs) in SUNFISH decreased over three years, and a trend towards a lower rate of serious adverse events (SAEs) was observed in the third year of treatment. Overall, AEs and SAEs were reflective of the underlying disease and no treatment-related AEs led to withdrawal from the study. In addition, for the first time an external comparator analysis has been done for SUNFISH two-year data with an untreated control group. The weighted exploratory analyses of MFM total scores showed that in SUNFISH Part 2, the proportion of patients demonstrating a marked improvement (change ≥3 points) or stabilisation (change ≥0 points) were more likely in patients who were on Evrysdi for 24 months than those in the untreated comparator group. (p=0.025 and p=0.002 respectively). “We are pleased that these long-term results further reinforce the safety and efficacy of Evrysdi and it is especially encouraging to see that adverse events decreased over time,” said Levi Garraway, M.D., Ph. D., Chief Medical Officer and Head of Global Product Development. “We remain committed to working towards continued access to Evrysdi for all appropriate patients with this progressive disease.” Updated interim data from the RAINBOWFISH study were also shared, demonstrating the safety and efficacy of Evrysdi for newborns. In January, the U.S. Food and Drug Administration (FDA) granted priority review of a supplemental new drug application (sNDA) for the use of Evrysdi to treat pre-symptomatic babies under two months of age with SMA. To date, more than 5,000 people have been treated with Evrysdi in clinical trials, compassionate use or real-world settings. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. 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 76 countries and the dossier is under review in a further 29 countries. Evrysdi is currently being evaluated in five multicentre trials in people with SMA:

New data for Roche's Evrysdi (risdiplam) demonstrate long-term efficacy and safety in a broad population of people 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 new data for Evrysdi® (risdiplam) in spinal muscular atrophy (SMA). Presentations included new three-year data from the SUNFISH study which further confirmed the long-term efficacy and safety of Evrysdi in a broad population of people aged 2-25 years with Type 2 or Type 3 SMA. Additional presentations included exploratory two-year efficacy data from SUNFISH Part 2,

New Data for Genentech's Evrysdi (risdiplam) Demonstrate Long-Term Efficacy and Safety in a Broad Population of People With Spinal Muscular Atrophy (SMA)

Basel, 15 March 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its shareholders approved all proposals of the Board of Directors at its ordinary Annual General Meeting (AGM). Owing to the ongoing high infection rates, the AGM was held with only representatives of Roche Holding Ltd and those persons required by the Articles of Incorporation in attendance and with no shareholders physically present. The AGM was broadcast live on the Internet. Roche shareholders were able to exercise their rights via written or electronically submitted instructions to the independent proxy, Testaris AG. The independent proxy represented 77.25% of the total of 106,691,000 shares. The Management Report, the Financial Statements and the Consolidated Financial Statements for 2021 were approved.

Roche Annual General Meeting 2022

Basel, 08 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from its growing neuromuscular portfolio will be presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, 13 – 16 March 2022. Presentations include eight abstracts from its spinal muscular atrophy (SMA) programme and three from its Duchenne muscular dystrophy (DMD) programme, demonstrating Roche's commitment to advancing clinical understanding of these conditions with the aim of treating a broad range of people living with neuromuscular disorders.

Roche to present new Evrysdi data at MDA 2022 and highlight expanding neuromuscular disease portfolio

Basel, 02 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced an initial donation of essential medicines to Ukraine. Roche vehemently condemns the violent invasion of the country.

Roche announces donation of essential medicines to Ukraine

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.

News for Roche Holding AG Stock (RHHBY)