Welcome to our dedicated page for Roche Hldg news (Ticker: RHHBY), a resource for investors and traders seeking the latest updates and insights on Roche Hldg stock.
Roche Holding Ltd/ADR (RHHBY) is linked to a stream of news that reflects the company’s activities in biotechnology, pharmaceuticals and diagnostics. Recent announcements from Roche and its U.S. affiliate Genentech highlight regulatory approvals, late‑stage clinical trial results, new diagnostic platforms and agreements related to access and manufacturing.
Investors and healthcare observers following RHHBY news will see updates on oncology and haematology programmes, such as the U.S. Food and Drug Administration’s accelerated approval of Lunsumio VELO, a subcutaneous CD20xCD3 bispecific antibody for relapsed or refractory follicular lymphoma after at least two prior lines of systemic therapy. News also covers Phase III data for the investigational oral SERD giredestrant in ER‑positive early‑stage breast cancer, as well as new data on Lunsumio combinations and long‑term outcomes in lymphomas presented at major scientific meetings.
On the diagnostics side, Roche has reported the U.S. launch of next‑generation cobas 6800/8800 systems and software upgrades, CE Mark approval for its cobas Mass Spec solution reagent pack for antibiotics drug monitoring, and CE Mark for the cobas BV/CV assay for bacterial vaginosis and candida vaginitis. These stories illustrate how the company is expanding its in‑vitro diagnostic menu and enhancing laboratory efficiency.
Additional news items include European Commission approval of Gazyva/Gazyvaro for lupus nephritis and Genentech’s agreement with the U.S. government addressing prescription drug costs and direct‑to‑patient programmes. For users of this page, the RHHBY news feed offers a central place to review such regulatory milestones, clinical trial readouts, product launches and policy‑related developments associated with Roche and the Roche Group.
Roche announced that the FDA granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib and fulvestrant, for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. This designation follows positive Phase III INAVO120 results showing the inavolisib-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; HR=0.43, 95% CI: 0.32-0.59, p<0.0001).
Approximately 40% of patients with HR-positive breast cancer have a PIK3CA mutation, often leading to poorer prognosis and resistance to endocrine treatment. Data from INAVO120 are being submitted to other health authorities. Inavolisib is under investigation in additional Phase III studies for advanced breast cancer.
Genentech, part of the Roche Group, reported positive Phase Ib results for its dual GLP-1/GIP receptor agonist, CT-388, in treating obesity.
Over 24 weeks, a weekly subcutaneous injection of CT-388 led to a significant placebo-adjusted weight loss of 18.8% (p < 0.001). Important results included 100% of treated participants achieving over 5% weight loss, 70% over 15%, and 45% over 20%. Additionally, pre-diabetic participants normalized their glycemia levels.
No new safety signals were detected. Adverse events were consistent with the incretin drug class. Further trials involving obese patients with type 2 diabetes are expected to report results in the second half of 2024.
Roche reports positive Phase I results for its dual GLP-1/GIP receptor agonist CT-388 in treating obesity and type 2 diabetes. Over 24 weeks, CT-388 achieved a significant placebo-adjusted weight loss of 18.8% (p < 0.001). At week 24, 100% of participants treated with CT-388 achieved >5% weight loss, 70% achieved >15%, and 45% achieved >20%. The treatment normalized glycemia in all pre-diabetic patients, showing strong glucose homeostasis impact. No new safety signals were detected, and the treatment was well-tolerated.
Looking forward, Roche plans to evaluate CT-388 in obese patients with type 2 diabetes over a 12-week treatment duration, with data expected in the second half of 2024.
Roche announced the FDA approval of its HPV self-collection solution, one of the first such options in the U.S. This tool improves access to HPV testing by allowing women to privately collect their own samples, which are then analyzed in a lab. The solution addresses a significant gap, as over half of U.S. cervical cancer patients are underscreened. Over 13,000 U.S. women are diagnosed with cervical cancer annually, and approximately 4,000 die from it. HPV self-collection could enable early detection and treatment, supporting the WHO's goal to eliminate cervical cancer by 2030. Roche collaborated with the National Cancer Institute for this initiative.
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