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.

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Though obesity drugs continue to gain traction, it is currently a duopoly market. As analysts expect demand to grow at an encouraging pace, several biotech/pharma companies are rushing to enter this space.

4 Stocks That Could Break Novo Nordisk, Lilly's Obesity Duopoly

Data from the study shows that nearly half of the patients who received Roche's (RHHBY) subcutaneously-administered obesity drug lost more than 20% of their body weight after 24 weeks.

Roche (RHHBY) Posts Encouraging Phase I Obesity Drug Data

The weekly injection helped patients with obesity lose 18.8% of their weight relative to those who received a placebo, after 24 weeks in the phase one trial.

Roche says weight loss drug shows promising results in early trial

The race to develop powerful new weight-loss drugs grew even more heated on Thursday as Roche Holding AG released early-stage trial results for an experimental obesity treatment.

Roche ramps up obesity-drug competition with early-stage trial results

Roche Holding said its weight-loss drug candidate achieved positive results in an early-stage trial, giving the company a boost in its bid to catch up to Novo Nordisk and Eli Lilly in a class of medicines that has shaken up everything from pharma to snack companies.

Roche Climbs After Weight-Loss Drug Shows Efficacy

Roche shares gained 4.7% at the market open on Thursday after an early-stage trial showed that the obesity drug candidate by newly acquired Carmot Therapeutics led to significant weight loss.

Roche shares gain on obesity drug results from early-stage trial

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase Ib clinical trial of CT-388, a dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes. The study found that a once-weekly subcutaneous injection of CT-388 over 24 weeks resulted in significant weight loss in healthy adults with obesity compared to placebo. The weight loss achieved with CT-388.

Genentech Reports Positive Phase Ib Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People With Obesity

Basel, 16 May 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the Phase I clinical trial of CT-388, a dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes. The study found that a once-weekly subcutaneous injection of CT-388 over 24 weeks resulted in significant weight loss in healthy adults with obesity compared to placebo. The weight loss achieved with CT-388 was clinically meaningful, with a mean placebo-adjusted weight loss of 18.8% (p-value < 0.001). At week 24, 100% of CT-388 treated participants achieved a weight loss of >5%, 85% achieved >10%, 70% achieved >15%, and 45% achieved >20%. The treatment was well tolerated, with mild to moderate gastrointestinal-related adverse events being the most common, consistent with the incretin class of medicines that CT-388 belongs to. All participants with a pre-diabetes status at baseline became normoglycemic after 24 weeks of CT-388 treatment, whereas glycemic status of participants treated with placebo remained largely unchanged during this period.

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in people with obesity

Swiss drugmaker Roche on Wednesday said the US Food and Drug Administration (FDA) has approved its human papillomavirus (HPV) self-testing kit.

Roche says FDA approves HPV self-test in US

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

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