Health
[Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis
The first (FENhance 2) of two pivotal RMS studies met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses compared to teriflunomideIn a pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as OCREVUS, the only approved therapy in PPMSFull data from both studies will be shared at upcoming medical meetings; once the second RMS study (FENhance 1) has read out, which is expected in the first half of 2026, all data to
About this update from Roche Holding Ltd
[{"type":"image","alt":"F. Hoffmann-La Roche Ltd","displaySize":"","headline":null,"caption":"F. Hoffmann-La Roche Ltd","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":198,"url":"https://media.zenfs.com/en/globenewswire.com/d295bae68c32358ba6ac888e76c1cca2"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/TdqKHuoAMRswPfW7YQ22wg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTI3NztjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/d295bae68c32358ba6ac888e76c1cca2","width":300,"height":198}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"The first (FENhance 2) of two pivotal RMS studies met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses compared to teriflunomide","length":169,"tagName":"p"}]},{"val":[{"type":"text","content":"In a pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as OCREVUS, the only approved therapy in PPMS","length":149,"tagName":"p"}]},{"val":[{"type":"text","content":"Full data from both studies will be shared at upcoming medical meetings; once the second RMS study (FENhance 1) has read out, which is expected in the first half of 2026, all data together will be considered for submission to regulatory authorities","length":248,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":566,"olType":false},{"type":"text","content":"Basel, 10 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the first Phase III (FENhance 2) of two pivotal, similarly-designed Phase III studies (FENhance 1 and 2) in patients with relapsing multiple sclerosis (RMS) met its primary endpoint. Fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, significantly reduced the annualised relapse rate (ARR) compared to teriflunomide over a period of at least 96 weeks of treatment.","length":470,"tagName":"p"},{"type":"text","content":"Additionally, the Phase III FENtrepid pivotal study evaluating fenebrutinib, compared with OCREVUS® (ocrelizumab) in patients with primary progressive multiple sclerosis (PPMS), met its primary endpoint. The results showed that fenebrutinib was non-inferior compared to ocrelizumab, the only approved therapy in PPMS, as measured by a delay in the onset of composite confirmed disability progression over a period of at least 120 weeks of treatment. A...