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. (RHHBY) reports healthcare developments across medicines, diagnostics and digital health, including updates from Genentech as a member of the Roche Group. Recurring news covers operating and financial results, regional sales trends, product performance and regulatory disclosures tied to the company’s pharmaceutical and diagnostic portfolios.
Company updates frequently feature ophthalmology products and pipeline assets such as Vabysmo, Susvimo and vamikibart across retinal conditions including diabetic macular edema and neovascular age-related macular degeneration. Roche also reports clinical data in neurology and autoimmune disease, including fenebrutinib in multiple sclerosis and ENSPRYNG in myelin oligodendrocyte glycoprotein antibody-associated disease, along with diagnostics approvals and patient-education initiatives.
Roche (OTCQX:RHHBY) will present extensive new Alzheimer’s disease data at AAIC 2026 in London on 12–15 July. The 18 oral and poster presentations span investigational antibody trontinemab, NLRP3 inflammasome research, and CE‑marked Elecsys pTau217 and approved pTau181 blood tests for scalable Alzheimer’s diagnosis in primary and secondary care.
Genentech and Roche (OTCQX:RHHBY) will present extensive new Alzheimer’s disease data at AAIC 2026 in London, July 12‑15.
Highlights include five trontinemab oral presentations from the Phase Ib/IIa Brainshuttle AD study, the Phase III PrevenTRON trial design in preclinical Alzheimer’s, NLRP3 inflammasome perspectives, and multiple results on Elecsys pTau217 and pTau181 blood tests in primary and secondary care.
Genentech (OTCQX:RHHBY) reported positive Phase III Krascendo 1 results for divarasib in previously treated KRAS G12C non-small cell lung cancer.
Divarasib showed clinically meaningful, statistically significant improvements in progression-free and overall survival versus approved KRAS G12C inhibitors, with a consistent, manageable safety profile and no new safety signals. Genentech plans global regulatory submissions.
Roche (OTCQX:RHHBY) reported positive phase III Krascendo 1 results for divarasib in previously treated KRAS G12C non-small cell lung cancer.
Divarasib showed statistically significant improvements in progression-free and overall survival versus approved KRAS G12C inhibitors, with a safety profile consistent with prior data and no new safety signals observed.
Genentech (OTCQX:RHHBY) received FDA priority review for a supplemental BLA for Enspryng (satralizumab) to treat thyroid eye disease (TED). A decision is expected by October 15, 2026.
Phase III SatraGO data showed improvements in proptosis, clinical activity score, and diplopia, with no new safety signals and at-home subcutaneous dosing potential.
Roche (OTCQX:RHHBY) received FDA Priority Review for a supplemental Biologics License Application for Enspryng (satralizumab) to treat thyroid eye disease (TED). The application is supported by global phase III SatraGO-1 and SatraGO-2 data, with an FDA decision expected by 15 October 2026.
Enspryng is a subcutaneous therapy designed for convenient at-home use, showing improvements in proptosis, clinical activity score, and double vision, with no new safety signals reported.
Roche (OTCQX:RHHBY) launched AXELIOS 1, a next-generation sequencing platform based on SBX technology that combines high accuracy, speed, flexibility, scalability and cost efficiency.
The system enables end-to-end, same-day whole-genome sequencing in research, supports projects from small studies to massive cohorts, and debuts with real-world validation and collaborations with Hartwig Medical Foundation, Broad Clinical Labs, 10x Genomics and Google DeepVariant/XOOS tools in a USD 7.3 billion sequencing market.
Roche (OTCQX:RHHBY) reported that the FDA has accepted a supplemental Biologics License Application for subcutaneous Lunsumio VELO plus Polivy in adults with relapsed or refractory large B-cell lymphoma after ≥1 prior therapy, with a decision expected by 9 February 2027.
Phase III SUNMO data showed a 59% reduction in risk of disease progression or death versus R-GemOx (HR 0.41), and median PFS of 11.5 months versus 3.8 months. Safety was consistent with known profiles, with low cytokine release syndrome incidence.
Roche (OTCQX:RHHBY) received FDA approval for the VENTANA PTEN (SP218) RxDx Assay, the first IHC companion diagnostic to assess PTEN protein loss in prostate adenocarcinoma.
The test helps identify patients with PTEN-deficient metastatic mAPMN/S prostate cancer who may be eligible for combination treatment with TRUQAP (capivasertib), supporting more personalised therapy.
Genentech (OTCQX:RHHBY) reported that the FDA accepted its supplemental Biologics License Application and granted Priority Review for adjuvant Tecentriq and Tecentriq Hybreza plus chemotherapy in stage III dMMR/MSI-H colon cancer.
The review is based on Phase III ATOMIC data showing a 50% reduction in recurrence or death risk and 36‑month disease-free survival of 86% versus 76% with chemotherapy alone. The FDA decision is expected by October 9, 2026.