cagkansayin/iStock via Getty Images And from Carmot's 4-week data release last year, we know that 4-week efficacy was in the ballpark of Viking's VK2735 – absolute weight loss of 8.4% for CT-388 at its highest dose versus 7.8% for the highest VK2735 dose in its 4-week trial. Roche Holding (OTCQX:RHHBY) announced positive topline results from the phase 1b trial of its obesity candidate CT-388 this week and its share price received a 4% boost on the day of the announcement. The results look strong with 18.8% ...

Company Insights - Roche announced positive results from an early-stage study of its obesity drug candidate CT-388, showing a mean placebo-adjusted weight loss of 18.8% over 24 weeks [1] - Management described the results as 'clinically meaningful and statistically significant', with all patients achieving more than 5% weight loss and approximately 45% losing over 20% of their body weight [2] - The side effects of CT-388 were reported to be similar to those of currently marketed incretin-based medicines like Novo Nordisk's Wegovy and Eli Lilly's Zepbound [3] - CT-388 also demonstrated benefits for type 2 diabetes patients, with all pre-diabetic participants achieving normalized glycemia after 24 weeks [4] - Roche's shares have decreased by 13.3% year-to-date, contrasting with the industry's growth of 14.5% [5] - Roche entered the obesity market by acquiring Carmot Therapeutics for $2.7 billion, adding CT-388 and other incretin-based drug candidates to its pipeline [6] Industry Insights - The obesity market has gained significant attention, particularly after Novo Nordisk's FDA approval for Wegovy in 2021, which has seen consistent sales growth [7] - Eli Lilly recently launched Zepbound, following its FDA approval in December, contributing to the competitive landscape dominated by Novo Nordisk and Eli Lilly [8] - Research by Goldman Sachs predicts the U.S. obesity market will grow to $100 billion by 2030, prompting major pharmaceutical companies like Amgen and AstraZeneca to develop their own obesity drugs [9] - Amgen has completed an interim analysis of its phase II study for its GLP-1 receptor candidate MariTide, with top-line data expected in late 2024 [11] - AstraZeneca has entered an exclusive deal with Eccogene to develop an oral drug for obesity and related conditions, securing global rights outside of China [12]

A logo at the Roche Holding AG headquarters in Basel, Switzerland, on Thursday, Feb. 1, 2024. Roche on Thursday said its experimental weight loss drug showed promising results in an early-stage trial, boosting the company's bid to compete in the booming market for those treatments. The Swiss company joined a slate of drugmakers racing to develop obesity drugs through its almost $3 billion acquisition of Carmot Therapeutics in December. But its weekly weight loss injection, called CT-388, is still years away ...

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 ...

Sean Anthony Eddy/E+ via Getty Images Roche (OTCQX:RHHBY)(OTCQX:RHHBF)(OTCPK:RHHVF) still has good long-term prospects since the last time I wrote an article about it. This was with respect to an article entitled "Roche, With Ocrevus And Fenebrutinib Advancement, Should Be Top MS Contender". In this article, I noted that this company had good long-term value with Ocrevus, which has been approved to treat patients with multiple sclerosis [MS]. Plus, that it was working on another drug for its pipeline, k ...

Financial Data and Key Metrics Changes - The company reported a strong base business growth of 7% across both divisions, with overall group sales including COVID at plus 2% at constant exchange rates [98][106] - COVID-19 sales decreased by CHF 0.7 billion, indicating that the impact of COVID sales is largely behind the company [98][116] - The company confirmed guidance for mid-single-digit growth and intends to further increase dividends in Swiss francs [106][125] Business Line Data and Key Metrics Changes - Pharma sales reached CHF 10.9 billion, growing by 2% at constant exchange rates or 7% excluding Ronapreve [125] - Diagnostics division grew at 2% or CHF 0.1 billion at constant exchange rates, impacted by the washout of COVID-19 sales [62][106] - The diagnostics segment saw strong growth in pathology lab sales at plus 19%, driven by advanced staining and companion diagnostics [63] Market Data and Key Metrics Changes - U.S. sales were slightly down by about 1%, primarily due to buying patterns and softer demand, but the hematology franchise showed strong growth [29] - The company experienced a decline in Japan due to mandatory price cuts and the absence of Ronapreve sales, with a 6% decline in constant exchange rates [125] - The company noted that the washout of COVID-19 is complete, with only a minor impact of around 0.6% to 0.7% on overall growth rates expected for the remainder of the year [116] Company Strategy and Development Direction - The company is focusing on pipeline prioritization, having removed 20% of total NMEs while bringing in high-value assets in areas such as hypertension and obesity [114] - The integration of point of care and diabetes care into one organization aims to leverage complementary patient segments and technologies [115] - The company is optimizing its manufacturing network, having divested its Vacaville biologics manufacturing facility for CHF 1.2 billion to enhance efficiency [117] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the base business, with expectations for single-digit growth in the U.S. for Hemlibra despite recent competitive pressures [87] - The company anticipates strong uptake for Ocrevus subcutaneous, viewing it as a blockbuster opportunity with significant market potential [90] - Management highlighted the importance of upcoming regulatory approvals and clinical data readouts, particularly in neurology and oncology [99][127] Other Important Information - The company achieved U.S. approval for XOLAIR in food allergies, marking it as the first and only medicine for this indication [17] - The diagnostics division is set for a significant launch year, with multiple key launches planned [18] - The company has received breakthrough device designation for the pTau217 ruling assay for Alzheimer's disease, indicating a strong focus on neurology [99] Q&A Session Summary Question: Impact of KEYTRUDA on Tecentriq sales and competition in small cell lung cancer - Management indicated that Tecentriq sales globally will stabilize as peak sales are reached in key indications, with competition impacting U.S. sales [42] Question: Changes in pipeline criteria for NMEs - Management clarified that while there was a 20% reduction in NMEs, new criteria for inclusion in the pipeline have been established to focus on high-value opportunities [76] Question: Updates on Columvi and its sales potential - Management confirmed that Columvi's recent positive data from the STARGLO study will be submitted to health authorities, indicating potential for future sales growth [81][127] Question: Expectations for Ocrevus subcutaneous uptake - Management expects strong uptake for Ocrevus subcutaneous, viewing it as a significant opportunity for new patient growth [90] Question: Competitive landscape for inavolisib - Management noted that inavolisib's selective profile may lead to a strong switch opportunity from Piqray, despite previous challenges with the latter [91]

Growth rates – from 31.12.2022 to 31.12.2023 (Total installed modules as of 31.12.2023) SWA=Serum Work Area 49 Accu-Chek SmartGuide CGM solution Enabling better decision-making for people with diabetes Accu-Chek SmartGuide CGM solution Improving diabetes management and care continuum • Data released at ATTD shows strong performance of first Roche CGM • 14 days of reliable and accurate real-time glucose sensor data • Predictive algorithms for 2 hours and night-time hypo • Addressing the needs of T1D and T2D ...

Swiss pharma giant Roche Holding AG’s (RHHBY) first-quarter 2024 revenues declined 6 % to CHF 14.4 billion due to the appreciation of the Swiss franc against most currencies and lower COVID-19-related sales. Nevertheless, sales were up 2% at constant exchange rates (CER) as demand for newer drugs as well as diagnostics products, including immunodiagnostics, clinical chemistry tests and advanced staining solutions, more than offset the anticipated decline in COVID-19-related sales and the impact of biosimila ...

A logo at the Roche Holding AG headquarters in Basel, Switzerland, on Thursday, Feb. 1, 2024.Swiss pharmaceutical company Roche on Wednesday reported a modest uptick in first-quarter sales, even as waning demand for its Covid-19 products continued to weigh on the company.Sales were up 2% at constant exchange rates, led by stronger demand for Roche's newer medicines and diagnostics, the company said. Excluding Covid-19 products, sales were up 7%. But sales tightened when reported in the company's local curre ...

Roche (RHHBY) announced that the FDA has approved a label expansion of its lung cancer drug, Alecensa.The drug is now approved 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 a kinase inhibitor, already approved as the first and second-line treatment for ALK-positive metastatic NSCLC, in various countries like the United States, Eur ...