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.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive new data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks.

New Phase III Data Show Genentech's Vabysmo Rapidly Improved Vision and Reduced Retinal Fluid in People With Retinal Vein Occlusion (RVO)

New agreement expands activities to include a wide-range of companion diagnostics, including tissue and blood-based biomarkers, sequencing and digital pathology. Collaboration builds on commitment to personalised healthcare through expanding access of companion diagnostics to enable targeted treatment options for patients.

Roche expands collaboration with Janssen to advance personalised healthcare through companion diagnostics

Genentech Announces Positive Data From Global Phase III Program for Crovalimab in PNH, a Rare, Life-Threatening Blood Condition

Basel, 7 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the global phase III COMMODORE 2 study, evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal haemoglobinuria (PNH) who have not been previously treated with complement inhibitors. The study met its co-primary efficacy endpoints of transfusion avoidance and control of haemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). Results showed that crovalimab, a novel, investigational anti-C5 recycling monoclonal antibody, given as a subcutaneous injection every four weeks, achieved disease control and was non-inferior to eculizumab, a current standard of care, which is given intravenously every two weeks.

Roche announces positive data from global phase III programme for crovalimab in PNH, a rare life-threatening blood condition

Roche's (RHHBY) performance in 2022 was sub-par as demand for COVID-19-related products declined significantly and 2023 will also be impacted.

Roche's (RHHBY) 2022 Core Earnings Grow, 2023 Outlook Dismal

Despite lower sales of COVID-19 test devices and related drugs, the company turnover increased by 1%. Roche is a dividend aristocrat. This would be the 36th consecutive DPS increase.

Roche: Lower Guidance In 2023, But Positive Trajectory

Roche Holding AG (OTCQX:RHHBY) Q4 2022 Earnings Conference Call February 2, 2023 8:00 AM ET Company Participants Severin Schwan - CEO & Executive Director Thomas Schinecker - CEO, Roche Diagnostics Matthew Sause - CEO Alan Hippe - Chief Financial & Information Officer Bruno Eschli - Head, IR Conference Call Participants Emmanuel Papadakis - Deutsche Bank Matthew Weston - Crédit Suisse Emily Field - Barclays Bank Luisa Hector - Berenberg Andrew Baum - Citigroup Sarita Kapila - Morgan Stanley Operator My name is Henrik, and I'm the technical operator for today's call. Kindly know that the webinar is being recorded.

Roche Holding AG (RHHBY) Q4 2022 Earnings Call Transcript

Roche Holding AG reported sales growth in 2022, but said it expects a decrease in sales for 2023 due to a drop in the sale of Covid-19 products.

Roche profit misses forecasts, sees COVID-19 related sales decline ahead

Basel, 2 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Board of Directors has made the following appointments:

[Ad hoc announcement pursuant to Art. 53 LR] Changes in Roche's Corporate Executive Committee

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results for 2022 despite decline in demand for COVID-19 products

Basel, 01 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission approved the expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation. The label will now include the routine prophylaxis of bleeding episodes in people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII ≥1% and ≤ 5%) with a severe bleeding phenotype.3 Haemophilia A affects around 900,000 people worldwide,4,5 approximately 14% of whom have a moderate form of the disease.6

European Commission approves label expansion of Roche's Hemlibra to include people with moderate haemophilia A in the EU

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Two Barron's Annual Roundtable, plus one Bloomberg Intelligence articles published late-January listed 99 intriguing stocks for 2023; 77 were unduplicated US publicly-listed companies, of which, 56 paid-dividends. Barron's two roundtable discussions January 20 and 27 split 49 picks from 9 panelists in half, whereas Bloomberg detailed all 50 in their January 16 BusinessWeek edition.

Barron's And Bloomberg 2023 Ideal Dividend Stocks Of The Year

Jana Care and Roche Diagnostics aim to develop point-of-care blood testing portfolio to address unmet needs for patients at-home and in remote settings. Jana Care's at-home testing platform to be distributed to global markets through Roche.

Jana Care to Enter Collaboration with Roche to Develop and Distribute Blood Testing Platform to Improve Remote Care for Patients With Chronic Kidney and Heart Disease

Roche has launched a new PCR test to detect a fast-spreading sub-variant of the Omicron variant of Coronavirus, the Swiss drugmaker said on Thursday.

Roche launches new test to detect fast spreading Omicron sub-variant

Basel, 26 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and its subsidiary TIB Molbiol have developed a COVID-19 PCR test for researchers that detects and differentiates the latest variant of concern, XBB.1.5. The XBB.1.5 variant is prevalent in the United States and is quickly spreading to other countries. Being able to differentiate emerging variants and understand their similarities and mutations provides a basis for experts to make predictions about their spread and respond with appropriate treatment strategies. The test, VirSNiP SARS-CoV-2 Spike F486P, is for use on the LightCycler® 480 II and cobas ® z 480.

Roche launches COVID-19 PCR test to detect the fast spreading XBB.1.5 Omicron sub-variant

Roche's (RHHBY) phase III IMbrave050 study, evaluating Tecentriq plus Avastin for treating early-stage hepatocellular carcinoma, meets its primary endpoint.

Roche (RHHBY) Tecentriq Meets Adjuvant Liver Cancer Study Goal

Basel, 19 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMbrave050 study met its primary endpoint of recurrence-free survival (RFS) at the prespecified interim analysis. The study is evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as adjuvant treatment following surgery for people with early-stage hepatocellular carcinoma (HCC) at high risk of disease recurrence. The Tecentriq combination showed a statistically significant improvement in RFS in the intention-to-treat population of HCC patients who have an increased risk of recurrence following resection or ablation with curative intent, compared with active surveillance.

[Ad hoc announcement pursuant to Art. 53 LR] Roche's Tecentriq plus Avastin is the first treatment combination to reduce the risk of cancer returning in people with certain types of early-stage liver cancer in a Phase III trial

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMbrave050 study met its primary endpoint of recurrence-free survival (RFS) at the prespecified interim analysis. The study is evaluating Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) as adjuvant treatment following surgery for people with early-stage hepatocellular carcinoma (HCC) at high risk of disease recurrence. The Tecentriq combination showed a statistically significant improvement in RFS in the intention-to-treat population of HCC patients who have an increased risk of recurrence following resection or ablation with curative intent, compared with active surveillance.

Genentech's Tecentriq Plus Avastin Is the First Treatment Combination to Reduce the Risk of Cancer Returning in People With Certain Types of Early-Stage Liver Cancer in a Phase III Trial

The European Commission approves Roche's (RHHBY) Xofluza for treating uncomplicated influenza and post-exposure prophylaxis of influenza in children aged one year and above.

Roche (RHHBY) Gets EU Approval for Xofluza in New Patient Base

Basel, 12 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Xofluza® (baloxavir marboxil) in children aged one year and above for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus. The Commission's Decision is based on the results of the phase III miniSTONE-2 and BLOCKSTONE studies.1 ,2 This approval marks the first single-dose, oral influenza medicine approved in Europe for children, and now means that Xofluza can be used to treat and prevent uncomplicated influenza in children aged one year and above, and in adolescents and adults.3

Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above

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The pipeline is the heart of a drug discovery company. As such, analyzing the health of a pipeline can lead to suggestions about future performance.

Ranking The Top 10 Pharmaceuticals By Pipeline

Kronos Bio

Shares of Kronos Bio Inc. KRON, +2.38% jumped 25% in premarket trading on Monday after the company announced a development deal with Roche Holding's ROG, -0.46% Genentech. Kronos has a drug discovery platform that will be used to support Genentech's research in small-molecule drugs for cancer.

Kronos Bio's stock rallies after announcing drug-discovery deal with Roche

The FDA accepts and grants priority review to Roche's (RHHBY) biologics license application for glofitamab to treat relapsed or refractory large B-cell lymphoma. The decision is due on Jul 1, 2023.

Roche's (RHHBY) Cancer Drug Glofitamab Gets FDA Priority Review

Basel, 6 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) and granted priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. LBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and is one of the most prevalent types of blood cancer among adults in the U.S.1 The FDA is expected to make a decision on approval of this novel cancer immunotherapy by 1 July 2023. If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with an aggressive lymphoma who have previously received multiple courses of treatment.

FDA grants priority review to Roche's bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma

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 Biologics License Application (BLA) and granted Priority Review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. LBCL is an aggressive (fast-growing) type of non-Hodgkin's lymphoma (NHL) and is one of the most prevalent types of blood cancer among adults in the U.S. The FDA is expected to make a decision on approval of this novel cancer immunotherapy by July 1, 2023. If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with an aggressive lymphoma who have previously received multiple courses of treatment.

News for Roche Holding AG Stock (RHHBY)