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, 05 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet' age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to 80 million people globally.1-4 The Vabysmo PFS will become available to United States (US) retina specialists and their patients in the coming months.

FDA approves Roche's Vabysmo prefilled syringe (PFS) for three leading causes of vision loss

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to three million.

FDA Approves Genentech's Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision Loss

Roche (RHHBY) announces that its mid to late-stage lung cancer study evaluating the tiragolumab combination therapy compared with Keytruda fails to meet primary endpoints.

Roche's (RHHBY) Combo Therapy Misses Lung Cancer Study Goals

Roche will end a lung cancer trial testing its new immunotherapy after the drug did not show a benefit over established treatment Keytruda by Merck & Co , casting further doubt on the drug candidate pioneered by the Swiss company.

Roche to halt trial in latest setback for lung cancer immunotherapy

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the Phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (nSq NSCLC), did not meet its primary endpoints of progre.

Genentech Provides Update on Phase II/III SKYSCRAPER-06 Study in Metastatic Non-Squamous Non-Small Cell Lung Cancer

Basel, 04 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq® (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival (PFS) at its primary analysis with a hazard ratio (HR) of 1.27 [95% CI: 1.02,1.57] and overall survival (OS) at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature. The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared to the comparator arm in the intent-to-treat population, which includes the phase II and phase III cohorts. The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified. Based on these results, patients and investigators will be unblinded and we intend to halt the study. A communication will be sent to the investigators and results will be shared with health authorities and subsequently presented at an upcoming medical meeting.

[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on phase II/III SKYSCRAPER-06 study in metastatic non-squamous non-small cell lung cancer

Roche (RHHBY) gets CHMP recommendation for a label expansion of ophthalmology drug Vabysmo (faricimab) and PiaSky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria.

Roche (RHHBY) Gets Positive CHMP Recommendation for Its Drugs

Basel, 28 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Vabysmo® (faricimab) marketing authorisation to include the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). A final decision regarding the approval is expected from the European Commission in the near future.

Roche's Vabysmo gets CHMP recommendation for third indication retinal vein occlusion (RVO)

Basel, 28 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for PiaSky® (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). The CHMP has recommended PiaSky, a novel recycling monoclonal antibody that inhibits the complement protein C5, for use in adults and adolescents (12 years of age or older with a weight of 40 kg) who are either new to, or have been previously treated with C5 inhibitors. If approved, PiaSky will be the first monthly subcutaneous (SC) treatment for PNH in the European Union, with the option to self-administer following adequate training. This may provide an alternative option to current C5 inhibitors that require regular intravenous (IV) infusions, potentially helping to reduce treatment burden and disruption to the lives of people with PNH and their caregivers.1 A final decision regarding the approval of PiaSky is expected from the European Commission in the near future.

CHMP recommends EU approval of Roche's PiaSky for people with PNH, a rare, life-threatening blood condition

Basel, 27 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the World Health Organization (WHO) has awarded the cobas® HPV test prequalification designations for use on the cobas® 5800 system and for self-collected samples on the cobas® 5800, 6800 and 8800 systems. These new prequalification designations come just one month after the U.S. Food and Drug Administration approved Roche's HPV self-collection solution and less than a year after the WHO awarded prequalification to the cobas HPV test on the cobas 6800/8800 systems.

Roche expands access to cervical cancer screening tools with two new WHO prequalification designations, including HPV self-collection

Roche (RHHBY) obtains approval for the subcutaneous formulation of relapsing multiple sclerosis drug Ocrevus in Europe. In addition, a review of the company's MAA for gene therapy, Elevidys, is also underway.

Roche's (RHHBY) Ocrevus Subcutaneous Gets European Commission Nod

Basel, 25 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for OCREVUS® (ocrelizumab) subcutaneous (SC) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS SC is a 10-minute injection that maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion. More than 350,000 people with multiple sclerosis have been treated with OCREVUS IV globally.

Roche's OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis

The stock price of Roche (OTCMKTS: RHHBY) trades at $35 per share, about 33% below its peak level of over $53 seen in April 2022. In contrast, its peer Bristol Myers Squibb stock (NYSE: BMY) saw a 48% decline over this period.

Will Roche Stock Rebound To Its 2022 Highs Of $50?

Basel, 24 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its new analytical units, cobas® c 703 and cobas® ISE neo, for the cobas® pro integrated solutions, in countries accepting the CE mark. The cobas pro integrated solutions is a scalable and modular diagnostic platform designed for high-volume laboratories. The cobas c 703 and cobas ISE neo analytical units offer cutting-edge features to help address some of the key challenges faced by diagnostic laboratories worldwide such as shortage of qualified staff and space limitations.

Roche launches new analytical units for cobas® pro integrated solutions delivering greater efficiency and capacity to laboratories

The U.S. Food and Drug Administration on Thursday approved Roche's drug for a chronic blood disorder, the Swiss drugmaker said.

US FDA approves Roche's drug for a chronic blood disorder

Basel, 20 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the first clinically approved, highly-sensitive in-situ hybridisation (ISH) test, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries accepting the CE Mark. The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection.4

Roche launches new highly-sensitive test to more easily diagnose patients who may have B-cell lymphoma

Roche (RHHBY) gets exclusive, target-specific rights to Ascidian's RNA exon editing technology for undisclosed neurological targets for an initial payment of $42 million.

Roche (RHHBY), Ascidian Team Up for RNA Exon Editing Therapeutics

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The Alzheimer's treatment landscape presents a compelling opportunity for investors in healthcare and biotech. Alzheimer's disease is a progressive and debilitating neurodegenerative disorder that poses a significant and growing threat to global health and economic well-being.

Alzheimer's Drug Stocks: Investing in Eli Lilly, Biogen, Roche

Roche continues to face challenges tied to lackluster revenue and profit outlook, questionable pipeline, and an underperforming diagnostics business. Roche spends aggressively on its pipeline (R&D and M&A) and is more successful than peers in converting R&D to revenue by some metrics, but trailing growth rates are quite lackluster. If key pipeline candidates like tiragolumab, prasinezumab, and RG6631 come through, Roche could see revenue and earnings reacceleration.

More Of The Same Isn't Good Enough For Roche

Swiss drugmaker Roche will team up with privately held biotech Ascidian Therapeutics to develop gene therapies targeting difficult to treat neurological diseases, the Boston-based startup said on Tuesday.

Roche partners with Ascidian Therapeutics to develop gene therapies

The solution, which includes the VENTANA DP 200 slide scanner, Roche's digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images. Primary diagnosis for digital pathology enhances healthcare efficiency and helps ensure effective and timely patient care, especially in areas where access to pathologists is limited.

Roche receives FDA clearance on its digital pathology solution for diagnostic use

Roche's (RHHBY) Columvi significantly extends survival in patients with relapsed or refractory diffuse large B-cell lymphoma in the phase III STARGLO study.

Roche (RHHBY) Reports Upbeat Data on Columvi From STARGLO Study

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today statistically significant and clinically meaningful results from its Phase III STARGLO study of Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) versus Rituxan® (rituximab) in combination with GemOx (R-GemOx) for people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line.

Genentech's Phase III STARGLO Study Demonstrates Columvi Significantly Extends Survival in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Roche's (RHHBY) Alecensa gets the European Commission's approval as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer.

Roche (RHHBY) NSCLC Drug Alecensa Gets EC Nod for Label Expansion

Roche in a lawsuit accused manufacturers and sellers based in India of selling counterfeit versions of its Accu-Chek devices on Amazon. Roche said the test strips are expired or nearly expired products that are repackaged with counterfeit labels bearing Roche's registered U.S. trademarks and fake expiration dates.

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