Late-breaking Phase III FENtrepid results presented at ACTRIMS show fenebrutinib met primary endpoint compared to OCREVUS in reducing disability progression in PPMS, with a 12% reduction in risk as early as 24 weeks. Fenebrutinib has potential to become first-in-class oral BTK inhibitor for PPMS and RMS. Regulatory submission planned following FENhance 1 readout. Results shared at ACTRIMS Forum 2026. FENtrepid study involved 985 adult patients with PPMS. Fenebrutinib showed consistent clinical benefit, particularly in upper limb function. Adverse events comparable to OCREVUS, with transient liver enzyme elevations in fenebrutinib group. Fenebrutinib designed to target relapsing and progressive biology by inhibiting B cells and microglia. Late-breaking Phase III FENtrepid results showed fenebrutinib met its primary endpoint in reducing disability progression in PPMS compared to OCREVUS. Fenebrutinib has the potential to be a first-in-class treatment for multiple sclerosis. Regulatory submission is planned for 2026, pending Phase III FENhance 1 results. The Phase III program includes trials in both PPMS and RMS with over 2,700 patients treated. Roche is committed to neuroscience research and has a robust pipeline of medicines for neurological disorders. Sustainability and innovation are core values at Roche, aiming to improve global healthcare delivery.

Source: https://www.globenewswire.com/Tracker?data=SnoKxO5mfsnvxnLSUum55Go4kvuQWUI8wKcj8ZCp2u28qw-so-XGhCCV1fjtCvxym_Xmg4l4xZqW-r174GYOHZHiypAwnPv3x8joEmtaTdttw_jYQ_bgvXP2FHCMNEzJEOP5Oycyd52-9KSU-CWgYgNzADGhvu1LTgAoLXcbksyCgHtIRqrB197au-jCwMq2uTM2VSsRrKjx1daBYnvFF1f0FvgQFI_FTyW11m8l8iY

Read more at “GlobeNewswire”: Roche’s fenebrutinib is the first investigational medicine