Roche Hldg Stock Price, News & Analysis

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.

Genentech (OTCQX: RHHBY) announced positive Phase III ALLEGORY results for Gazyva (obinutuzumab) in adults with systemic lupus erythematosus (SLE) on standard therapy dated November 3, 2025. The study met the primary endpoint (higher percentage achieving SRI-4 at one year/52 weeks) and all key secondary endpoints, including BICLA response, sustained corticosteroid control (weeks 40–52), SRI-6 at 52 weeks, and time to first flare (BILAG). No new safety signals were identified. Data will be presented at an upcoming medical meeting and shared with regulators including FDA and EMA.

Roche (OTCQX: RHHBY) announced that its subsidiary accepted for payment all shares validly tendered in its tender offer to acquire 89bio (NASDAQ: ETNB) at $14.50 per share in cash plus a non-tradeable contingent value right (CVR) for up to $6.00 per share. The tender offer expired at one minute after 11:59 p.m. New York time on October 29, 2025, and approximately 94,113,710 shares were validly tendered, representing about 60.49% of outstanding 89bio shares (excluding guaranteed-delivery certificates). Roche intends to complete a merger today to acquire the remaining shares, after which 89bio will become a wholly owned Roche subsidiary and its shares will cease trading on the Nasdaq Global Market.

Roche (OTCQX:RHHBY) received CE mark on 29 October 2025 for the Elecsys Dengue Ag test, a fully automated, high-throughput immunoassay to aid diagnosis of acute dengue infection. The test reports results in 18 minutes, claims high clinical sensitivity and specificity, and is inclusive for all four dengue virus serotypes. Automation aims to improve lab efficiency, traceability and reduce human error, supporting faster workflows and patient management during outbreaks. The announcement cites rising global dengue burden, with a 2024 peak of over 14.6 million cases and >12,000 deaths.

Genentech (OTCQX: RHHBY) reported positive Phase III INShore results for Gazyva (obinutuzumab) in children and young adults (ages 2–25) with idiopathic nephrotic syndrome on Oct 28, 2025. The study met its primary endpoint: more participants achieved sustained complete remission at week 52 versus mycophenolate mofetil (MMF).

Key secondary endpoints met included higher relapse-free survival, longer median time to relapse or death, reduced cumulative corticosteroid dose to week 52, and fewer relapses through week 52. No new safety signals were identified; safety aligned with the known adult profile. Data will be presented at a medical meeting and submitted to regulators including the FDA and EMA.