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.
Genentech (OTCQX:RHHBY) reported that the U.S. FDA granted priority review to its supplemental Biologics License Application for Gazyva (obinutuzumab) in adults with primary membranous nephropathy (pMN). The decision is based on Phase III MAJESTY results showing Gazyva’s superiority to tacrolimus, with 36.9% of adults achieving complete remission at two years versus 5.7% on tacrolimus (adjusted difference 31.1%; 95% CI 18.2–44.0; p<0.001).
The FDA, which previously granted Breakthrough Therapy Designation in pMN, is expected to decide on approval by November 2026. If approved, Gazyva would become the first FDA‑approved therapy for pMN. According to Genentech, safety in MAJESTY was consistent with Gazyva’s known profile, with no new safety signals identified. Gazyva already has U.S. and EU approvals for active lupus nephritis and has generated positive Phase III data across several immune‑mediated diseases.
Roche (OTCQX:RHHBY) announced the introduction of the cobas HDV test for use on its fully automated cobas 5800/6800/8800 systems in countries that accept the CE mark. The assay detects and quantifies Hepatitis D Virus (HDV) RNA, enabling clinicians to both diagnose infections and monitor treatment response.
According to Roche, this is the first high-throughput, fully automated HDV assay available, addressing reliance on manual and lab-developed tests. The launch supports care for an estimated 12 million people globally affected by HDV and aligns with the rollout of new HDV-specific treatments.
Roche (OTCQX:RHHBY) received CE Mark for its Elecsys IGRA TB blood test, enabling automated identification of tuberculosis infection on cobas immunoassay systems. The assay provides results in under 24 hours, processes each patient in about 19 minutes, and is designed for scalable, high-throughput laboratory workflows.
According to Roche, Elecsys IGRA TB showed 91.12% positive percent agreement, 94.57% negative percent agreement, 100% relative sensitivity in bacteriologically confirmed TB patients, and 95.32% specificity in a low-risk cohort when compared with established standard-of-care methods.
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.