Roche Hldg Stock Price, News & Analysis

Genentech (OTCQX: RHHBY) announced FDA accelerated approval of Lunsumio VELO (mosunetuzumab-axgb) as a subcutaneous treatment for adult patients with relapsed or refractory follicular lymphoma after two or more prior systemic therapies, based on the Phase I/II GO29781 study.

Key trial results: ORR 75%, CR 59%, median duration of response 22.4 months. Administration is a ~one-minute subcutaneous injection versus a 2–4 hour IV infusion; treatment can be fixed-duration (as short as six months). Approval is accelerated and may require confirmatory trial verification. Common adverse reactions include injection site reactions, fatigue, rash and cytokine release syndrome (CRS) occurred in 30% (mostly Grade 1–2).

Genentech (OTCQX: RHHBY) announced an agreement with the U.S. government on December 19, 2025 that aims to lower prescription drug costs for state Medicaid programs, expand direct-to-patient access for its influenza medicines via TrumpRx.gov, and encourage other wealthy countries to reward biopharmaceutical innovation.

The company reaffirmed a $50 billion U.S. investment in manufacturing, infrastructure, and R&D, cited support for more than 11,000 jobs (including ~6,500 construction jobs) and up to 1,000 new skilled roles, and secured a three-year tariff exemption to enable continued onshoring. Specific agreement terms remain confidential.

Roche (OTCQX: RHHBY) announced U.S. launch of cobas 6800/8800 systems version 2.0 and software v2.0.1 after FDA 510(k) clearance earlier in 2025. The upgrade increases assay flexibility (unique assays per run 3→6), allows up to 6 assays per sample, and supports simultaneous LDT and IVD testing. A second analytic unit option for cobas 6800 can boost throughput to 2,112 tests/day. The update is available as a software upgrade to existing systems and aims to reduce downtime, consolidate test menus, and address staffing and cost pressures while modernizing the user interface.

Roche (OTCQX: RHHBY) announced on 11 December 2025 that it secured CE Mark approval for its mass spectrometry reagent pack for antibiotics drug monitoring, expanding its automated cobas Mass Spec IVD menu to 39 tests. The menu already covers therapeutic drug monitoring for immunosuppressants and antibiotics, steroid hormones and vitamin D metabolites, and aims to bring gold-standard mass spectrometry into routine labs via a fully automated workflow that reduces turnaround times and standardises results. Roche also reported a CLIA “moderate complexity” designation in the US for the first analyte, and said the solution is available in selected CE-mark markets and other countries including the UK, Canada and Japan. Roche plans further menu expansion and ongoing regulatory engagement.

Genentech (OTCQX: RHHBY) announced positive Phase III lidERA results showing adjuvant giredestrant reduced the risk of invasive disease recurrence or death by 30% (HR=0.70, 95% CI 0.57-0.87, p=0.0014) versus standard-of-care endocrine therapy in ER-positive, HER2-negative early-stage breast cancer.

At three years, iDFS was 92.4% with giredestrant vs 89.6% with SoC ET; distant recurrence-free interval improved by 31% (HR=0.69). Overall survival data were immature at interim analysis. Data to be presented at the 2025 San Antonio Breast Cancer Symposium.

Roche (OTCQX: RHHBY) announced positive phase III lidERA results showing investigational oral SERD giredestrant reduced the risk of invasive disease recurrence or death by 30% versus standard-of-care endocrine therapy (HR=0.70, 95% CI 0.57-0.87, p=0.0014) in ER-positive, HER2-negative early-stage breast cancer (pre-specified interim analysis).

At three years, 92.4% of patients on giredestrant were alive and free of invasive disease versus 89.6% with SoC ET. Giredestrant also cut distant recurrence risk by 31% (HR=0.69). Overall survival data are immature; safety was described as manageable. Results will be presented at the 2025 San Antonio Breast Cancer Symposium.

Roche (OTCQX: RHHBY) received the CE Mark for its cobas® BV/CV PCR assay on 9 December 2025 to detect bacteria causing bacterial vaginosis and yeast causing candida vaginitis from a single vaginal swab.

The test enables broader sexual health testing on cobas 5800/6800/8800 systems without an additional sample, aims to improve diagnostic accuracy versus microscopy/pH/clinical observation, and is now available in countries accepting the CE Mark.

Market context: the global sexual health segment is valued at CHF 1.1 bn with 11% annual growth; vaginitis growth is cited at 26% yearly.

Roche (RHHBY) announced that the European Commission approved Gazyva/Gazyvaro (obinutuzumab) on 9 December 2025 for adults with active Class III or IV, with or without Class V, lupus nephritis, in combination with mycophenolate mofetil (MMF).

The approval was based on phase II NOBILITY and phase III REGENCY results: 46.4% of patients on Gazyva plus standard therapy achieved complete renal response versus 33.1% on standard therapy alone. Data also showed reduced corticosteroid use and improved proteinuric response. The EC decision follows a U.S. FDA approval in October 2025. Roche said the treatment could benefit up to an estimated 135,000 people with lupus nephritis in the EU.

Roche (OTCQX: RHHBY) presented data at ASH 2025 showing Lunsumio (mosunetuzumab) combinations may be effective earlier in lymphoma care.

Key results: a 54-patient US CELESTIMO cohort of Lunsumio plus lenalidomide showed a CR 87.0% (95% CI: 75.1–94.6) with mostly low-grade CRS; Lunsumio plus Polivy in 2L+ LBCL gave ORR 77.5% vs 50.0% (comparator) and median PFS 25.4 vs 6.4 months. Long-term follow-up in R/R FL showed durable responses, including a 5-year OS 78.5% and sustained CR durations for IV and SC formulations.