Roche Hldg Stock Price, News & Analysis

Roche (OTCQX: RHHBY) announced the European Commission granted conditional marketing authorisation for Lunsumio (mosunetuzumab) subcutaneous for adult patients with relapsed or refractory follicular lymphoma after two or more systemic therapies (3L+ FL) on 19 November 2025.

Approval is based on the phase I/II GO29781 study showing pharmacokinetic non‑inferiority vs IV and no unexpected safety signals. Lunsumio SC offers an approximately one‑minute injection versus a 2–4 hour IV infusion. Long‑term IV data show 57% of patients in CR remained in remission at five years. Data will be presented at ASH and have been submitted to other regulators including the FDA; Phase III studies including MorningLyte are ongoing.

Genentech (RHHBY) announced positive Phase III lidERA results on November 18, 2025, where investigational oral giredestrant met the trial's primary endpoint at a pre-planned interim analysis.

The study showed a statistically significant and clinically meaningful improvement in invasive disease-free survival versus standard-of-care endocrine monotherapy in ER-positive, HER2-negative early-stage breast cancer. Overall survival was immature but showed a positive trend. Giredestrant was well tolerated with no unexpected safety findings. lidERA is described as the first Phase III SERD to show adjuvant benefit and follows a prior positive Phase III readout (evERA) presented at ESMO 2025.

Roche (OTCQX: RHHBY) reported positive Phase III results from the lidERA trial of investigational oral SERD giredestrant in ER-positive, HER2-negative early-stage breast cancer on 18 November 2025. At a pre-planned interim analysis the study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in invasive disease-free survival versus standard-of-care endocrine monotherapy.

lidERA is described as the first Phase III SERD to show a benefit in the adjuvant setting and is the second positive Phase III readout for giredestrant after evERA. Overall survival was immature at interim but trended positively; safety was consistent with the known profile with no unexpected findings. Data will be presented at a medical meeting and shared with health authorities.

Roche (OTCQX: RHHBY) commissioned a Europe survey (5,518 respondents) and found 31% of eligible millennials (age 29–42) postponed or missed cervical screening—27% above the all-age average. The research reports fear (30%) and workplace demands as top barriers, with high-income earners 22% more likely to delay and 27% of parents reporting missed appointments. Millennials cited workplace flexibility (19%), travel/childcare support (12%), and encouragement (10%) as motivators. Roche promotes self-sampling and tailored outreach to increase attendance and advance its cervical cancer elimination campaign.

Genentech (OTCQX: RHHBY) reported that the first pivotal RMS Phase III (FENhance 2) met its primary endpoint, with investigational fenebrutinib significantly reducing annualized relapse rate versus teriflunomide over at least 96 weeks. In the pivotal PPMS study (FENtrepid), fenebrutinib was non-inferior to ocrelizumab for delaying composite confirmed disability progression over at least 120 weeks, with a numerical benefit seen from week 24 onward. Liver safety was reported as consistent with prior studies and additional safety data are under evaluation. The second RMS readout (FENhance 1) is expected in the first half of 2026 and together with the remaining data will inform regulatory submissions.

Roche (OTCQX: RHHBY) reported pivotal Phase III results for investigational fenebrutinib in multiple sclerosis. In the first RMS study (FENhance 2) fenebrutinib significantly reduced annualised relapse rate versus teriflunomide over at least 96 weeks. In the PPMS study (FENtrepid) fenebrutinib was non-inferior to ocrelizumab for delaying composite confirmed disability progression over at least 120 weeks, with a numerical benefit seen from week 24 onward. Liver safety was consistent with prior studies and additional safety data are under evaluation. The second RMS readout (FENhance 1) is expected in the first half of 2026; all data will be considered together for regulatory submission.

Genentech (OTCQX: RHHBY) will present 46 abstracts, including 12 oral presentations, at the 67th ASH Annual Meeting in Orlando, Dec 6-9, 2025. Key highlights cover Hemophilia A, lymphoma and multiple myeloma across approved medicines and pipeline programs.

Notable entries: post‑marketing BEYOND ABR data for Hemlibra; positive Phase I/II results for next‑gen bispecific NXT007 with planned Phase III in 2026; SPK‑8011QQ preclinical gene therapy driving a Phase IIb start in 2026; multiple lymphoma and myeloma oral/poster presentations with long‑term follow‑up and QoL data.

Roche (OTCQX: RHHBY) will present 46 abstracts, including 12 oral presentations, at ASH 2025 (6-9 Dec 2025) covering haemophilia A, lymphoma and multiple myeloma.

Key items: Hemlibra post‑marketing BEYOND ABR data report low bleeding rates and improved joint health after switching from factor VIII; NXT007 positive phase I/II results support planned Phase III in 2026; SPK-8011QQ shows enhanced preclinical potency with Phase IIb planned for 2026; lymphoma and myeloma programs (Lunsumio, Columvi, cevostamab, mosunetuzumab, polatuzumab) report longer‑term follow‑up, QoL and subgroup analyses. Regulatory note: Columvi+GemOx is approved in 49 countries, and the US supplemental BLA received a Complete Response Letter on 2 July 2025.

Roche (RHHBY) announced on 3 November 2025 that the phase III ALLEGORY study of Gazyva/Gazyvaro (obinutuzumab) in adults with systemic lupus erythematosus (SLE) met the primary endpoint and all key secondary endpoints at 52 weeks.

Key findings include a higher percentage of patients achieving a minimum four‑point improvement in SRI‑4 at one year versus standard therapy, statistically significant benefits on BICLA, sustained corticosteroid control (weeks 40–52), sustained SRI‑4 (weeks 40–52), SRI‑6 at 52 weeks, and longer time to first flare. No new safety signals were identified.

Data will be presented at a medical meeting and shared with regulators; if approved, Gazyva/Gazyvaro would be the first anti‑CD20 therapy for SLE to directly target B cells.