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 interim results from the Phase III HAVEN 7 study. The study shows Hemlibra® (emicizumab-kxwh) achieved meaningful bleed control with a favorable safety profile in infants (up to 12 months) with severe hemophilia A without factor VIII inhibitors: 77.8% of participants did not have any bleeds that required treatment and 42.6% did not have any treated or untreated bleeds at all. These results help support the use of Hemlibra in this population, in which it is already approved in many countries around the world. The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.

Interim Data From Phase III Study Presented at ASH 2022 Show Hemlibra (emicizumab-kxwh) Achieved Meaningful Bleed Control in Infants From Birth

Basel, 11 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from the phase III COMMODORE 3 study in China, demonstrating that crovalimab, a novel anti-C5 recycling monoclonal antibody, is efficacious and well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH). The study met its co-primary efficacy endpoints of transfusion avoidance (TA) and haemolysis control, demonstrating that participants with PNH, who have not been treated previously with complement inhibitors and who received subcutaneous crovalimab injections every four weeks, achieved disease control.1 The data were presented at the American Society of Hematology (ASH) congress, taking place from 10-13 December 2022.

Roche's subcutaneous crovalimab given every four weeks achieves disease control in people with PNH, a life-threatening blood condition

Looking at the longer term, Roche stock is up 27% from levels seen in late 2018, compared to around 65% returns for the S&P500 index.

What's Driving Roche Stock?

The Ferrero Group, the Italian confectionery group, said it has agreed to buy Wells Enterprises, the world's largest family owned and managed ice cream company, for an undisclosed sum. Iowa-based Wells, whose brands include the Blue Bunny ice cream and the low-calorie Halo Top range, was founded in 1913 and produces more than 200 million gallons of ice cream per year.

Ferrero Roche owner agrees to buy Blue Bunny ice cream maker Wells Enterprises

Basel, 8 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and pTau181 assays (used as a pTau181/Abeta42 ratio) measure two biomarkers that are hallmarks of Alzheimer's pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease.

Roche Alzheimer's disease Cerebrospinal Fluid (CSF) assays receive FDA clearance, supporting more accurate and timely diagnosis

INDIANAPOLIS , Dec. 5, 2022 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the appointment of Brad Moore as president and CEO of Roche Diagnostics North America, effective January 1, 2023. Moore currently serves as senior vice president, Core Lab and Point of Care, within Roche Diagnostics North America.

Roche Announces Brad Moore as President and CEO of Roche Diagnostics North America

Swiss drugmaker Roche is closing down most clinical trials of its experimental Alzheimer's drug gantenerumab after it failed to slow advance of the mind-robbing disease in a pair of large, late-stage studies, the company said on Wednesday.

Roche shutters most trials of Alzheimer's drug after failed trials

Roche fails Alzheimer's treatment and consequently the stock declined. In numbers, we were estimating a 25% chance to reach $10 billion in sales (equal to 2% of the company's net present value).

Roche: Another Key Fail.

Roche gets FDA Emergency Use Authorization for Monkeypox virus test

Basel, 16 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for cobas® MPXV for use on the cobas® 6800/8800 Systems. The test is a real time PCR test for the qualitative detection of DNA from monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection by their healthcare provider.

Roche receives U.S. FDA Emergency Use Authorization for its high-throughput test to detect monkeypox virus

Roche's (RHHBY) gantenerumab study for early Alzheimer's disease (AD) fails and puts focus on other companies like BIIB, LLY and PRTA.

Roche (RHHBY) AD Study Failure Puts Spotlight on BIIB & Others

Analysts were busy chopping back forecasts for Swiss group Roche going forward after what was described by one as the 'unequivocal failure' of gantenerumab, its treatment for Alzheimer's. Shares in Biogen, Eli Lilly and Prothena, all competitors developing alternative therapies, jumped on the news but there were few straws to clutch for the Swiss giant, said commentators.

Roche Alzheimer's failure good news for rivals, analysts suggest

Seattle biotech startup Bonum Therapeutics raised $93 million less than two months after its parent company Good Therapeutics was bought for $250 million by Roche, with the potential for milestone payments.

Seattle biotech startup born out of a Roche buyout lands $93M to advance therapies

Jnana to leverage its RAPID chemoproteomics platform to discover novel small molecule drugs directed to targets across a diverse range of target classes in cancer, immune-mediated and neurological diseases. Jnana will receive $50 million upfront, significant near-term milestone payments, and is eligible to receive potential future milestone payments exceeding $2 billion.

Jnana Therapeutics Announces Second Collaboration with Roche to Address Challenging-to-Drug Targets in Cancer, Immune-Mediated and Neurological Diseases

Developed as a predictive biomarker, the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers. The new test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE.

Roche receives FDA approval for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE

Biogen

Eli Lilly

Prothena

Roche said its experimental Alzheimer's treatment failed in two final-phase studies, leading Biogen stock to surge while others crumbled. The post Roche's Alzheimer's Drug Fails In Phase 3; Here's The Fallout For Biogen, Lilly, Prothena And Others appeared first on Investor's Business Daily.

Roche's Alzheimer's Drug Fails In Phase 3; Here's The Fallout For Biogen, Lilly, Prothena And Others

The disappointing results come weeks after a similar treatment developed by two competitors delivered promising data, infusing fresh hope into a field that has been marked by a string of failures.

Alzheimer's Drug From Roche Fails in Late-Stage Trials

The Swiss pharma company said the drug failed to slow patients' clinical decline, in contrast to positive results from Biogen earlier this year.

Roche Sinks as Alzheimer's Drug Disappoints. Biogen is Gaining.

Morphosys AG - ADR

German-listed shares of MorphoSys MOR, -31.96% MOR, +2.44% lost a third of their value on Monday after its partner Roche said an Alzheimer drug trial failed. Roche ROG, -3.76% slumped 4% in Zurich as the company said Phase 3 studies evaluating gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer's and mild Alzheimer's dementia did not meet their primary endpoint of slowing clinical decline.

MorphoSys shares plunge after partner Roche says Alzheimer's drug trials didn't meet goals

Roche Holding AG said Monday that Phase 3 Graduate studies of gantenerumab, for treatment of early Alzheimer's disease, failed to meet its primary endpoints.

Roche says Phase 3 studies for Alzheimer's drug failed to meet primary endpoints

Roche said its Alzheimer's drug candidate could not clearly be shown to slow dementia progression in two drug trials, failing to draw level with a recent development success by rivals Biogen and Eisai.

Roche's Alzheimer's drug fails to meet goal in long awaited trial

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the Phase III GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer's and mild Alzheimer's dementia, collectively called early Alzheimer's disease. The studies did not meet their primary endpoints of slowing clinical decline. Gantenerumab was well tolerated including the subcutaneous administration.

Genentech Provides Update on Phase III GRADUATE Program Evaluating Gantenerumab in Early Alzheimer's Disease

Basel, 14 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the GRADUATE I and II studies evaluating gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer's and mild Alzheimer's dementia, collectively called early Alzheimer's disease. The studies did not meet their primary endpoint of slowing clinical decline. Gantenerumab was well tolerated, including the subcutaneous administration.

[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III GRADUATE programme evaluating gantenerumab in early Alzheimer's disease

The COVID-19 At-Home Test that tens of millions of Americans received via the U.S. government is now available over-the-counter nationwide under the new Pilot name and brand. Accurate, fast and easy to use, the Pilot COVID-19 At-Home Test is the first over-the-counter test launched by Roche Diagnostics in the U.S. Following Centers for Disease Control and Prevention (CDC) guidance for at-home testing and appropriate next steps can help reduce the spread of COVID-19.

Roche launches Pilot brand, expands retail channels for COVID-19 At-Home Test

Basel, 9 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced publication of the Safety, Tolerability and Efficacy of Rapid Optimization of Heart Failure (STRONG-HF) study in patients hospitalised for acute heart failure. The study, which includes utilisation of the Roche Elecsys NT-proBNP biomarker, was terminated early for superior efficacy in the active arm of the study versus the usual standard of care, as it was considered unethical to continue with usual care.

News for Roche Holding AG Stock (RHHBY)