Genentech says FDA accepts fenebrutinib filing for multiple sclerosis
Genentech said the U.S. FDA accepted its New Drug Application for fenebrutinib under priority review for relapsing and primary progressive multiple sclerosis. The filing is based on three Phase III studies, including FENhance 1 and 2 and FENtrepid.
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05:05:34 AM UTC
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Roche’s US FDA accepted its fenebrutinib NDA for relapsing MS, primary progressive MS under priority review. Phase III RMS trials cut annualized relapse rates by 51.1% and 58.5% versus teriflunomide over 96 weeks. In PPMS, fenebrutinib met non-inferiority versus Ocrevus on disability progression, showing a 12% numerical risk reduction. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Roche Holding AG published the original content used to generate this news brief via (Ref. ID: 202609300100OMX_____CNEWS_EN_GNW1001275352_en) on September 30, 2026, and is solely responsible for the information contained therein. (C)