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Roche (ROG) investor relations material

Roche Study update summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Study update summary9 Feb, 2026

Key study results and clinical insights

  • Phase III FENtrepid trial showed fenebrutinib achieved non-inferiority to ocrelizumab/OCREVUS in reducing disability progression in PPMS, with a 12% risk reduction (HR 0.88, 95% CI 0.75–1.03) and numerically favorable outcomes from week 24 onward.

  • The strongest treatment effect was observed on the Nine-Hole Peg Test (9HPT), with a 26% risk reduction (HR 0.74, 95% CI 0.56–0.98), especially in patients without gadolinium-enhancing lesions.

  • Consistent treatment effects were observed across predefined subgroups, including age, sex, prior DMT use, and baseline disease characteristics.

  • Post-hoc analysis revealed a 22% risk reduction on a composite endpoint (EDSS and 9HPT) compared to OCREVUS.

  • Results were presented at the ACTRIMS Forum 2026.

Safety and tolerability

  • Adverse events and serious adverse events were comparable between fenebrutinib and ocrelizumab/OCREVUS; 96.3% vs 93.7% for any AE, and 19.1% vs 18.9% for serious AEs.

  • Fenebrutinib had more fatal events (1.4% vs 0.2%) and higher liver enzyme elevations, all of which resolved; no confirmed Hy's Law cases were observed, and all fatal events were deemed unrelated to treatment.

  • Transient, reversible, asymptomatic hepatic transaminase elevations were more common with fenebrutinib, resolving after the first 20 weeks.

  • Every-two-week liver monitoring was introduced to mitigate risk, successfully preventing further high-level elevations.

  • Rates of known BTKi-related AEs, including infections, nausea, and hemorrhage, were mostly comparable between groups.

Study design and population

  • FENtrepid was a multicenter, randomized, double-blind, double-dummy, parallel-group Phase III study with 985 adult PPMS patients aged 18–65, EDSS 3.0–6.5, comparing daily oral fenebrutinib 200 mg BID to IV ocrelizumab/OCREVUS 600 mg every 24 weeks over at least 120 weeks.

  • The primary endpoint was time to onset of 12-week composite confirmed disability progression (CCDP12), incorporating EDSS, Timed 25-Foot Walk, and 9HPT.

  • Most events were captured by the Timed 25-Foot Walk, but the strongest treatment effect was on the 9HPT.

  • Patients can enter an open-label extension phase to receive fenebrutinib.

  • Superiority to ocrelizumab was tested but not met; non-inferiority was achieved.

Oral fenebrutinib's market advantage vs OCREVUS?
Address fenebrutinib's liver enzyme elevations
Impact of FENhance 1 on PPMS submission timeline?
Fenebrutinib's liver risk vs. Tolebrutinib CRL
Fenebrutinib B-cell depletion vs. other BTKs
Fenebrutinib patient segments for market growth
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Frequently asked questions

The Vanguard of Biomedical Innovation

Roche Holding AG, commonly referred to as Roche is a Swiss multinational healthcare company with a rich history dating back to 1896. From its headquarters in Basel, Roche is active with operations in pharmaceuticals and diagnostics, with aportfolio spanning oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. As one of the largest healthcare companies globally, Roche's products and services reach millions of people all over the globe.

From Humble Origins to Global Impact

Founded by Fritz Hoffmann-La Roche, Roche started as a small drug factory but quickly grew to become a leading player in the pharmaceutical industry. In its early years, Roche distinguished itself through its focus on innovation and international outlook, becoming the first company to mass-produce synthetic vitamin C in the 1930s. The company's focus on innovation and the development of new medicines has not wavered since its inception. Roche's pharmaceutical pipeline remains a critical factor in its ongoing growth, continually reinforcing its position as an important player in global healthcare.

What They Do

The company develops and provides innovative healthcare solutions, with a significant emphasis on oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. Its pharmaceutical division works to research, develop, and market medications. Simultaneously, its diagnostics division delivers insights into diseases, providing doctors with tools for early detection, targeted treatment, and patient monitoring. Roche is a pioneer in integrated healthcare solutions, deeply investing in genomics and data analytics, underpinning its commitment to personalized medicine. As a global pharmaceutical and healthcare company they compete with names like Novartis, Pfizer, Novo Nordisk, and many others.

Strategic Acquisitions

The company is deeply invested in advancing the understanding and treatment of diseases through genetic insights. This commitment can be exemplified in its acquisition of Foundation Medicine and Flatiron Health, companies specializing in cancer genomics and real-world evidence solutions, respectively. These acquisitions supplement Roche's in-house efforts to develop therapies targeting the genetic drivers of disease.

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