Roche Hldg Stock Price, News & Analysis

Roche (OTCQX: RHHBY) announced FDA approval of Gazyva/Gazyvaro (obinutuzumab) on 20 October 2025 for adult patients with active lupus nephritis receiving standard therapy.

The approval followed phase II NOBILITY and phase III REGENCY data showing a higher complete renal response: 46.4% vs 33.1% with Gazyva/Gazyvaro plus standard therapy. The label permits four initial doses in year one, then dosing twice yearly, and a shorter 90-minute infusion option after the first infusion for eligible patients.

Genentech (RHHBY) announced FDA approval of Gazyva (obinutuzumab) on October 20, 2025 for adult patients with active lupus nephritis receiving standard therapy.

Approval was supported by Phase II NOBILITY and Phase III REGENCY, where 46.4% of patients on Gazyva plus standard therapy achieved complete renal response versus 33.1% on standard therapy alone. Gazyva showed reductions in proteinuria, anti-dsDNA, corticosteroid use, and complementary improvements in biomarkers. The label allows a shortened 90-minute infusion after the first dose for eligible patients and a dosing schedule of four initial doses in year one followed by twice-yearly maintenance.

Gazyva received Breakthrough Therapy designation in 2019 and has a recent CHMP positive opinion in Europe, with further regulatory decisions pending.

Roche (OTCQX: RHHBY) on 18 October 2025 reported positive phase III evERA results showing giredestrant plus everolimus significantly improved progression-free survival (PFS) versus standard-of-care endocrine therapy plus everolimus in post-CDK4/6 inhibitor ER-positive, HER2-negative advanced breast cancer.

Key metrics: PFS risk reduction of 44% (ITT; HR=0.56; median 8.77 vs 5.49 months) and 62% (ESR1-mutated; HR=0.38; median 9.99 vs 5.45 months). OS data were immature but trended favorably; safety was manageable with no new signals, including no photopsia.

Roche (OTCQX: RHHBY) reported phase III data for investigational vamikibart in uveitic macular edema (UME) from two pivotal trials, MEERKAT and SANDCAT, presented 17 October 2025.

MEERKAT showed statistically significant superiority versus sham for the primary endpoint: ≥15-letter BCVA gain at week 16 (0.25 mg +19.9% P=0.0008; 1 mg +36.9%). SANDCAT did not meet nominal primary significance (0.25 mg +20.7% nominal; 1 mg +10.9% P=0.0699). Both trials showed rapid mean BCVA and central subfield thickness (CST) improvements versus sham. Vamikibart was generally well tolerated with low intraocular inflammation rates and no retinal occlusive vasculitis observed.

Genentech (OTCQX:RHHBY) announced Phase III pivotal data for vamikibart in uveitic macular edema (UME) from two trials, MEERKAT and SANDCAT, presented at AAO 2025. MEERKAT showed statistically significant superiority vs sham for the primary endpoint: proportion gaining ≥15 letters (0.25 mg: +19.9%, P=0.0008; 1 mg: +36.9%). SANDCAT had nominal/non‑significant primary results (0.25 mg: +20.7% nominal; 1 mg: +10.9%, P=0.0699). Both trials showed rapid, clinically meaningful improvements in BCVA and large reductions in central subfield thickness. Vamikibart was generally well tolerated with low rates of intraocular inflammation and no retinal occlusive vasculitis reported.

Roche (OTCQX:RHHBY) announced that the European Medicines Agency's CHMP has recommended approval of Gazyva/Gazyvaro (obinutuzumab) with mycophenolate mofetil for adults with active Class III or IV lupus nephritis, with or without Class V. A European Commission decision is pending.

Recommendation is based on phase II NOBILITY and phase III REGENCY data: 46.4% of patients on Gazyva plus standard therapy achieved complete renal response versus 33.1% on standard therapy alone, with a significant reduction in corticosteroid use and improved proteinuric response. Safety was consistent with known haematology-oncology profile. An FDA decision is expected later this year.

Genentech (OTCQX: RHHBY) launched a Direct-to-Patient program for Xofluza on October 16, 2025 to expand access and affordability for the upcoming flu season.

Key features: a $50 cash-pay option (stated as 70% lower than list price) available via Alto Pharmacy and Mark Cuban Cost Plus Drug Company; same-day home delivery in select U.S. markets through Alto Pharmacy and Amazon Pharmacy; nationwide mail delivery via all three partner pharmacies; and an enhanced manufacturer coupon letting eligible patients pay as little as $35 with up to $70 off.

Xofluza is described as a single-dose oral antiviral for patients age 5 and up and for post-exposure prophylaxis. The release cites CDC estimates for the 2024-25 season: 47–82 million illnesses, 21–37 million medical visits, 610,000–1.3 million hospitalizations, and 27,000–130,000 deaths.

Roche (OTCQX:RHHBY) presented advances in its sequencing by expansion (SBX) technology at ASHG 2025, highlighting improvements across bulk RNA sequencing, methylation mapping, spatial analyses, and target enrichment.

Key developments include a GUINNESS WORLD RECORD™ by Broad Clinical Labs for fastest DNA sequencing (sample-to-VCF under four hours) achieved with Roche Sequencing Solutions and Boston Children’s Hospital, a new multi‑project evaluation with the Wellcome Sanger Institute, SBX‑Duplex combined with TAPS for methylation mapping, spatial sequencing at the University of Tokyo (≈15 billion reads in one hour), and a UMI‑based SBX‑Simplex target enrichment workflow.

Roche (ROG) announced on October 13, 2025 that the FDA cleared its Elecsys pTau181 blood test as the only blood-based biomarker test indicated for use in primary care to help rule out Alzheimer's-related amyloid pathology. The test is for patients aged 55 and older, was developed with Eli Lilly, and showed a 97.9% negative predictive value in a multicenter study of 312 participants reflective of a primary-care population. With > 4,500 Roche instruments already in U.S. labs and recent CE Mark/IVDR certification, Roche says the test can broaden access, improve referrals, and reduce more invasive confirmatory testing such as PET and CSF.