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.

Pakistan's drug regulator said on Monday it had temporarily banned the use of a cancer medication distributed by Swiss pharmaceutical company Roche pending an investigation, as 12 patients went blind after being injected with the drug.

Pakistan bans Roche cancer drug pending probe into patients' blindness

Roche has optionality to grow its pipeline with selective M&A and new partnerships. The company also confirmed better pharmaceutical growth expectations. We evaluated the three biggest readouts, Elevidys, TIGIT, and Inavolisib, providing supportive news. From a premium valuation to a discount vs. its closest peers. We believe this is not justified. Our buy rating is confirmed.

Roche: Positive Readouts From Pipeline

Roche's stock price has declined, underperforming its peers, due to the loss of patent protection for its blockbuster drugs, lower Covid-related revenue and several pipeline setbacks. The company has developed second-generation drugs and expanded into new therapeutic areas to offset the decline in revenue. 2023 is expected to be a challenging year for Roche, but revenue is projected to grow again in 2024 and beyond.

Roche: 2023 Should Mark The Bottom

Alnylam Pharmaceuticals

BridgeBio Pharma Inc

The pharmaceutical industry is one of the most dynamic and innovative sectors in the world. It is constantly developing new drugs and treatments to address various health challenges and improve the quality of life of millions of people.

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Roche is open to making big acquisitions if they make "sense", Chief Executive Thomas Schinecker said, with the Swiss drugmaker unencumbered by its $20.7 billion deal last year to buy back its shares from Novartis.

Roche open to big acquisitions 'if it makes scientific and financial sense' - CEO tells newspaper

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Basel, 7 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam announced today that the Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT), met the primary endpoint. Zilebesiran demonstrated a clinically significant reduction in 24-hour mean systolic blood pressure (SBP) at month three, achieving a placebo-subtracted reduction greater than 15 mmHg with both 300 and 600 mg doses (p < 0.0001). The study also met key secondary endpoints showing consistent and sustained reductions of SBP at six months supporting quarterly or biannual dosing. In addition, the study showed that zilebesiran was associated with a potent and durable reduction of serum AGT levels through month six while demonstrating an encouraging safety and tolerability profile.

Roche and Alnylam report positive topline results from Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension in patients at high risk of cardiovascular disease

A new form of accounting that more accurately reflects the impact a company has on the planet and society is essential, the executive said.

Impact accounting 'urgently' needed - Roche's Hoffmann

Roche (RHHBY) biologics license application seeking approval for crovalimab for paroxysmal nocturnal hemoglobinuria gets FDA acceptance.

Roche's (RHHBY) Application for PNH Drug Accepted by FDA

DALLAS--(BUSINESS WIRE)--CyrusOne, a leading global data center developer and operator, specializing in delivering state-of-the-art digital infrastructure solutions, today announced the promotion of Jim Roche to Senior Vice President of Engineering. In this role, Roche will lead CyrusOne's engineering development team, overseeing engineering and design services including power and usage projections, floor planning, connectivity assessments and implementation scheduling . Roche most recently ser.

CyrusOne Promotes Jim Roche to Senior Vice President of Engineering

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 accepted the company's Biologics License Application (BLA) for crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The acceptance was based on results from the pivotal Phase III COMMODORE 2 study, which demonstrated that in pe.

FDA Accepts Application for Genentech's Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition

The report shows digital health technologies demonstrate value, yet integrating them into care systems remains challenging. Involving healthcare professionals and patients in technology design and development is also critical for patient-centred care.1 The report surveyed 10 countries, all of which have some foundations in place to use digital health technologies, such as regulatory frameworks and interoperability standards.

Economist Impact report, Advancing the frontier of health and technology integration: The 2023 Digital Health Barometer highlights opportunities in digitalisation of healthcare

Roche's (RHHBY) late-stage ALK-positive non-small cell lung cancer study evaluating Alecensa meets the primary endpoint of disease-free survival.

Roche's (RHHBY) Late-Stage Lung Cancer Study Meets Primary Goal

Basel, 01 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Phase III ALINA study evaluating Alecensa® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis. Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected stage IB (tumour ≥4cm) to IIIA (UICC/AJCC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Alecensa is the first and only ALK inhibitor to demonstrate a reduction in the risk of disease recurrence or death for people with early-stage ALK-positive NSCLC in a Phase III trial.

Roche's Alecensa delivers unprecedented Phase III results 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 Phase III ALINA study evaluating Alecensa® (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis. Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected Stage IB (tumor ≥.

Genentech's Alecensa Delivers Unprecedented Phase III Results for People With ALK-Positive Early-Stage Lung Cancer

Following the label expansion, Roche's (RHHBY) Evrysdi is now approved to treat people of all ages with SMA in the European Union.

Roche's (RHHBY) Evrysdi Gets Label Expansion in EU for Newborns

Basel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Tecentriq® SC (atezolizumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. It will be provided by the National Health Service (NHS) England. Injecting Tecentriq subcutaneously (under the skin) takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq SC will be available to patients in Great Britain for all indications in which the IV formulation of Tecentriq has been previously approved, including certain types of lung, bladder, breast and liver cancer.2

Roche's Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes

Basel, 29 August 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved the extension of the Evrysdi® (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies from birth to below two months.1 Interim data from the ongoing RAINBOWFISH trial in pre-symptomatic babies from birth to six weeks with Type 1 SMA supported the marketing authorisation extension.

European Commission approves Roche's Evrysdi for babies under two months old with spinal muscular atrophy (SMA)

Shares of several companies developing anti-TIGIT therapies rise after Roche (RHHBY) accidentally leaks encouraging late-stage study data.

Biotech Stocks Rally After Roche's (RHHBY) Accidental Data Leak

Roche's (RHHBY) stock jumps 4.3% on Wednesday after the company inadvertently publishes encouraging second interim analysis data from its combination drug study to treat cancer.

Roche (RHHBY) Up on Upbeat Data From Combo Drug Cancer Study

Gilead Sciences

Merck

Cancer drug stocks were boosted on Wednesday after Roche accidentally published positive interim results from its lung cancer treatment study. The Swiss drugmaker said that it had been made aware of the inadvertent disclosure of the second interim analysis from its Phase 3 study evaluating its investigational anti-TIGIT (T cell immunoreceptor with immunoglobulin and ITIM domains) immunotherapy tiragolumab in combination with the established immune-oncology drug Tecentriq for people with lung cancer.

Cancer drug stocks soar after Roche accidentally releases positive interim lung cancer trial results

iTeos Therapeutics, Inc.

Arcus Biosciences

Roche accidentally published positive interim results from a lung cancer treatment study, which boosted shares of rivals Iteos and Arcus.

How Roche's Accidental Cancer Update Lifted Iteos And Arcus More Than 30%

Shares of biopharmaceutical companies developing anti-TIGIT cancer therapies, including Gilead Sciences Inc. GILD, +0.54%, Arcus Biosciences Inc. RCUS, -0.84% and iTeos Therapeutics Inc. ITOS, +2.80%, got a boost premarket on Wednesday after Roche AG RHHBY, -1.10% said there had been an “inadvertent disclosure” of interim data from a study of its anti-TIGIT therapy tiragolumab in non-small cell lung cancer. The interim results showed positive data for overall survival with tiragolumab, but the results were “not mature” at the time of the analysis that was disclosed, Roche said in a release.

Gilead, Arcus, iTeos, other biopharmas get boost from accidental disclosure of Roche lung cancer trial data

Swiss drug maker Roche said on Wednesday it had been made aware of an inadvertent disclosure in a study of its new immunotherapy for patients with lung cancer using an experimental class of drugs known as anti-TIGIT.

Roche reports inadvertent disclosure in lung cancer immunotherapy study

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC). SKYSCRAPER-01.

News for Roche Holding AG Stock (RHHBY)