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, 15 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the FDA approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United States. Screening for HPV can help identify women who are at risk of developing cervical cancer so that the disease can be found and treated early before cervical cancer has a chance to develop.

Roche announces FDA approval of one of the first HPV self-collection solutions in the U.S., expanding access and screening options to help eliminate cervical cancer

Vabysmo and Phesgo are still strong growth drivers for the company going forward, growing year over year in Q1 of 2024 by 108% and 70%, respectively. Mid-single digit sales growth is expected to remain with the pipeline that it has established thus far, with several data readouts expected in 2024 to drive additional shareholder value. Ocrevus is expected to remain as the best-selling Multiple Sclerosis Drug in 2030, generating approximately $6.3 billion in sales.

Roche: Value Remains Despite Covid-19 Revenue Growth Loss

SAN DIEGO--(BUSINESS WIRE)--Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high-value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, today announced a landmark publication in Nature. The publication, “Chemoproteomic Discovery of a Covalent Allosteric Inhibitor of WRN Helicase,” by Kristen Baltgalvis et al, published jointly with our partner Roche, speaks to the chemical prote.

Vividion Therapeutics and Roche Jointly Publish Landmark Nature Paper on Clinical-Stage Covalent Allosteric Inhibitor of Werner Helicase (WRN)

Roche Holding AG (OTCQX:RHHBY) Q1 2024 Sales/ Trading Statement Conference Call April 24, 2024 8:00 AM ET Company Participants Thomas Schinecker - Chief Executive Officer, Roche Group Alan Hippe - Chief Financial & Information Officer Teresa Graham - Chief Executive Officer, Roche Pharmaceuticals Matt Sause - Chief Executive Officer, Roche Diagnostics Bruno Eschli - Head, Investor Relations Conference Call Participants Richard Vosser - JPMorgan Emmanuel Papadakis - Deutsche Bank Simon Baker - Redburn Matthew Weston - UBS Luisa Hector - Berenberg Sachin Jain - Bank of America Andrew Baum - Citi Tim Anderson - Wolfe Research Steve Scala - Cowen Richard Parkes - BNP Emily Field - Barclays Mark Purcell - Morgan Stanley Peter Welford - Jefferies Thomas Schinecker Thank you very much and hello and welcome. I'm looking forward to sharing the Q1 results together with my team with you today.

Roche Holding AG (RHHBY) Q1 2024 Sales/Trading Statement Call Transcript

Roche's (RHHBY) performance in first-quarter 2024 is pretty ho-hum as COVID-19-test sales continue to decline. The top line suffers due to the appreciation of the Swiss franc against most currencies.

Roche (RHHBY) Q1 Hit by Currency Headwinds, Lower COVID-19 Sales

Swiss pharmaceutical giant Roche on Wednesday said falling sales of COVID-19 tests and medicines will stop having a “material impact” on its business after the first quarter of 2024 following the end of a boom during the pandemic.

Roche prepares for business after boom from COVID-related products

Roche lowered its 2024 growth outlook in February as it continues to confront a drop-off in demand for its Covid-19 products and a number of its cancer drugs.

Swiss pharma giant Roche's first-quarter sales edge higher as its emerges from post-Covid-19 slump

Roche said on Wednesday its first-quarter sales slipped 6% as the loss on COVID-19 related revenue was partly offset by further gains in eye drug Vabysmo.

Roche Q1 sales down 6% on forex effect, loss of COVID revenue

Roche CEO Thomas Schinecker: “We had a strong start into the year, with both our divisions reporting high single digit growth in their base business – excluding COVID-19 sales. After this quarter, the COVID-19-related impact on sales is largely behind us. The appreciation of the Swiss franc versus most currencies impacted sales reported in Swiss francs compared to the same period last year. The uptake of our eye medicine Vabysmo continues its momentum. We are pleased about the US approval of Xolair as the first and only medicine for multiple food allergies. Further, we recently received the US approval for Alecensa in early-stage lung cancer. With an unprecedented 76% reduction in the risk of disease recurrence or death versus chemotherapy, Alecensa significantly improves upon the standard of care for this specific form of lung cancer.

[Ad hoc announcement pursuant to Art. 53 LR] Roche sales increase by 2% (CER) in first quarter with both divisions growing in high single digit ex COVID-19

Roche (RHHBY) has won FDA approval for Alecensa as an adjuvant treatment, following tumor resection for patients with ALK-positive non-small cell lung cancer.

Roche (RHHBY) Alecensa Wins FDA Nod for Label Expansion

Basel, 19 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours ≥ 4 cm or node positive), as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumour.

FDA approves Roche's Alecensa as the first adjuvant treatment for people with ALK-positive early-stage lung cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Alecensa® (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors ≥ 4 cm or node positive), as detected by an FDA-approved test. Alecensa is now the first and only ALK inhibitor approved for people.

FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today data from the Phase III OCARINA II study (S31.006) of Ocrevus® (ocrelizumab), an investigational twice-yearly, 10-minute subcutaneous (SC) injection. Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigat.

Genentech's Subcutaneous Ocrevus One-Year Data Demonstrates Near-Complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS

Basel, 17 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from the Phase III OCARINA II study (S31.006) of OCREVUS® (ocrelizumab), an investigational twice-yearly, 10-minute subcutaneous (SC) injection. Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigational formulation. Treatment with OCREVUS SC led to rapid and sustained B-cell depletion in the blood. The data will be presented as an oral presentation at the 76th American Academy of Neurology (AAN) Annual Meeting taking place April 13-18 in Denver and has been recognised as an abstract of distinction by the AAN scientific committee.

Roche's subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS

Roche's (RHHBY) Columvi, in combination with GemOx, achieves the primary endpoint of overall survival in a late-stage lymphoma study.

Roche's (RHHBY) Combination Therapy Meets Goal in Lymphoma Study

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, lived longer when treated with Columvi® (glofitamab-gxbm) in combination.

Genentech's Columvi Meets Primary Endpoint of Overall Survival in People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Study

Basel, 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, lived longer when treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx. Safety of the combination appeared consistent with the known safety profiles of the individual medicines. The data will be submitted to health authorities and shared at an upcoming medical meeting.

[Ad hoc announcement pursuant to Art. 53 LR] Roche's Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study

A Roche-Lilly collaboration to test for indications of Alzheimer's disease won FDA Breakthrough Device Designation on Thursday. The new test will now proceed to clinical trials needed for full FDA approval.

Why Roche Holdings Stock Popped Today

Basel, 11 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is being developed in collaboration with Eli Lilly and Company, will be used to help identify the presence or absence of amyloid pathology in individuals, which can help ensure they are able to receive appropriate care. This may include participation in clinical trials or access to approved disease-modifying therapies. If approved, the test could help rapidly broaden access to a more timely and accurate diagnosis and potentially mitigate the impact of Alzheimer's disease on people and society.

Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis

Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2.1 Patients with HER2-low status may now be eligible for HER2-targeted treatment, which could significantly improve their outcome.2 The VENTANA HER2 (4B5) test is the only approved companion diagnostic indicated as an aid in the assessment of HER2-low status in metastatic breast cancer patients. TUCSON, Ariz.

Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer eligible for ENHERTU

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BURLINGTON, Mass.--(BUSINESS WIRE)-- #AI--Brian Roche has been appointed CEO at Veracode. His ascension from Chief Product Officer completes a succession plan, which sees Sam King step down.

Veracode Embarks on a New Chapter with Appointment of Brian Roche as Chief Executive Officer

Basel, 26 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) approval of the cobas® Malaria test for use on the cobas® 6800/8800 Systems. This approved test can aid healthcare professionals in reducing potential risks of patient infection from transfused blood products. The cobas Malaria test provides a highly sensitive and specific solution to help ensure that infected blood units are removed from the blood supply.

Roche receives FDA approval for the first molecular test to screen for malaria in blood donors

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Hot Stocks: The 3 Best Opportunities for Investing in Weight Loss Drugs

Novo Nordisk's Wegovy represents a significant advancement in obesity treatment, demonstrating a more profound weight-loss effect compared to its predecessor, Saxenda. Eli Lilly's entry with Zepbound, targeting both GLP-1 and GIP, signifies a competitive market landscape, potentially outperforming Wegovy in efficacy. The race to redefine obesity treatment is heating up, with several other pharmaceutical companies developing GLP-1 agonists and exploring alternative targets.

News for Roche Holding AG Stock (RHHBY)